CETIRIZINE HYDROCHLORIDE ALLERGY از شرکت ORCHID HLTHCARE

اطلاعات داروی نمایش داده شده مستقیما از دیتابیس اطلاعات دارویی سازمان غذا و دارو آمریکا (FDA) استخراج می شود و مرتبا به روز رسانی می شود
داروی نمایش داده شده مورد تایید FDA می باشد و اطلاعات ثبت آن در زیر قابل مشاهده است

CETIRIZINE HYDROCHLORIDE ALLERGY از شرکت ORCHID HLTHCARE

Abbreviated New Drug Application (ANDA): 078862

Company: ORCHID HLTHCARE

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CETIRIZINE HYDROCHLORIDE ALLERGY CETIRIZINE HYDROCHLORIDE 5MG TABLET;ORAL Over-the-counter

None

No No
CETIRIZINE HYDROCHLORIDE ALLERGY CETIRIZINE HYDROCHLORIDE 10MG TABLET;ORAL Over-the-counter

None

No No
CETIRIZINE HYDROCHLORIDE HIVES CETIRIZINE HYDROCHLORIDE 5MG TABLET;ORAL Over-the-counter

None

No No
CETIRIZINE HYDROCHLORIDE HIVES CETIRIZINE HYDROCHLORIDE 10MG TABLET;ORAL Over-the-counter

None

No No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
02/19/2009 ORIG-1 Approval

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
11/05/2014 SUPPL-3 Labeling-Container/Carton Labels, Labeling-Package Insert

Label is not available on this site.

11/07/2014 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

CETIRIZINE HYDROCHLORIDE ALLERGY

The products listed here are over-the-counter (OTC) drugs and do not receive therapeutic equivalence ratings. They may not be interchangeable.

TABLET;ORAL; 5MG
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD Application No. Company
CETIRIZINE HYDROCHLORIDE ALLERGY CETIRIZINE HYDROCHLORIDE 5MG TABLET;ORAL Over-the-counter No 078780 AMNEAL PHARMS NY
CETIRIZINE HYDROCHLORIDE ALLERGY CETIRIZINE HYDROCHLORIDE 5MG TABLET;ORAL Over-the-counter No 078317 APOTEX INC
CETIRIZINE HYDROCHLORIDE ALLERGY CETIRIZINE HYDROCHLORIDE 5MG TABLET;ORAL Over-the-counter No 090760 AUROBINDO PHARMA LTD
CETIRIZINE HYDROCHLORIDE ALLERGY CETIRIZINE HYDROCHLORIDE 5MG TABLET;ORAL Over-the-counter No 076047 CONTRACT PHARMACAL
CETIRIZINE HYDROCHLORIDE ALLERGY CETIRIZINE HYDROCHLORIDE 5MG TABLET;ORAL Over-the-counter No 078343 DR REDDYS LABS LTD
CETIRIZINE HYDROCHLORIDE ALLERGY CETIRIZINE HYDROCHLORIDE 5MG TABLET;ORAL Over-the-counter No 202277 IPCA LABS LTD
CETIRIZINE HYDROCHLORIDE ALLERGY CETIRIZINE HYDROCHLORIDE 5MG TABLET;ORAL Over-the-counter No 078933 MARKSANS PHARMA
CETIRIZINE HYDROCHLORIDE ALLERGY CETIRIZINE HYDROCHLORIDE 5MG TABLET;ORAL Over-the-counter No 076677 MYLAN
CETIRIZINE HYDROCHLORIDE ALLERGY CETIRIZINE HYDROCHLORIDE 5MG TABLET;ORAL Over-the-counter No 078862 ORCHID HLTHCARE
CETIRIZINE HYDROCHLORIDE ALLERGY CETIRIZINE HYDROCHLORIDE 5MG TABLET;ORAL Over-the-counter No 078336 PERRIGO R AND D
CETIRIZINE HYDROCHLORIDE ALLERGY CETIRIZINE HYDROCHLORIDE 5MG TABLET;ORAL Over-the-counter No 077946 PLD ACQUISITIONS
CETIRIZINE HYDROCHLORIDE ALLERGY CETIRIZINE HYDROCHLORIDE 5MG TABLET;ORAL Over-the-counter No 077498 SUN PHARM INDS LTD
CETIRIZINE HYDROCHLORIDE ALLERGY CETIRIZINE HYDROCHLORIDE 5MG TABLET;ORAL Over-the-counter No 078072 TARO
CETIRIZINE HYDROCHLORIDE ALLERGY CETIRIZINE HYDROCHLORIDE 5MG TABLET;ORAL Over-the-counter No 077829 UNIQUE PHARM LABS
CETIRIZINE HYDROCHLORIDE ALLERGY CETIRIZINE HYDROCHLORIDE 5MG TABLET;ORAL Over-the-counter No 078427 WOCKHARDT
CETIRIZINE HYDROCHLORIDE HIVES CETIRIZINE HYDROCHLORIDE 5MG TABLET;ORAL Over-the-counter No 078343 DR REDDYS LABS LTD
CETIRIZINE HYDROCHLORIDE HIVES CETIRIZINE HYDROCHLORIDE 5MG TABLET;ORAL Over-the-counter No 202277 IPCA LABS LTD
CETIRIZINE HYDROCHLORIDE HIVES CETIRIZINE HYDROCHLORIDE 5MG TABLET;ORAL Over-the-counter No 078933 MARKSANS PHARMA
CETIRIZINE HYDROCHLORIDE HIVES CETIRIZINE HYDROCHLORIDE 5MG TABLET;ORAL Over-the-counter No 076677 MYLAN
CETIRIZINE HYDROCHLORIDE HIVES CETIRIZINE HYDROCHLORIDE 5MG TABLET;ORAL Over-the-counter No 078862 ORCHID HLTHCARE
CETIRIZINE HYDROCHLORIDE HIVES CETIRIZINE HYDROCHLORIDE 5MG TABLET;ORAL Over-the-counter No 078336 PERRIGO R AND D
CETIRIZINE HYDROCHLORIDE HIVES CETIRIZINE HYDROCHLORIDE 5MG TABLET;ORAL Over-the-counter No 077498 SUN PHARM INDS LTD
CETIRIZINE HYDROCHLORIDE HIVES CETIRIZINE HYDROCHLORIDE 5MG TABLET;ORAL Over-the-counter No 077829 UNIQUE PHARM LABS
CETIRIZINE HYDROCHLORIDE HIVES RELIEF CETIRIZINE HYDROCHLORIDE 5MG TABLET;ORAL Over-the-counter No 078780 AMNEAL PHARMS NY
CETIRIZINE HYDROCHLORIDE HIVES RELIEF CETIRIZINE HYDROCHLORIDE 5MG TABLET;ORAL Over-the-counter No 090760 AUROBINDO PHARMA LTD

The products listed here are over-the-counter (OTC) drugs and do not receive therapeutic equivalence ratings. They may not be interchangeable.

TABLET;ORAL; 10MG
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD Application No. Company
CETIRIZINE HYDROCHLORIDE ALLERGY CETIRIZINE HYDROCHLORIDE 10MG TABLET;ORAL Over-the-counter No 078780 AMNEAL PHARMS NY
CETIRIZINE HYDROCHLORIDE ALLERGY CETIRIZINE HYDROCHLORIDE 10MG TABLET;ORAL Over-the-counter No 078317 APOTEX INC
CETIRIZINE HYDROCHLORIDE ALLERGY CETIRIZINE HYDROCHLORIDE 10MG TABLET;ORAL Over-the-counter No 090760 AUROBINDO PHARMA LTD
CETIRIZINE HYDROCHLORIDE ALLERGY CETIRIZINE HYDROCHLORIDE 10MG TABLET;ORAL Over-the-counter No 076047 CONTRACT PHARMACAL
CETIRIZINE HYDROCHLORIDE ALLERGY CETIRIZINE HYDROCHLORIDE 10MG TABLET;ORAL Over-the-counter No 078343 DR REDDYS LABS LTD
CETIRIZINE HYDROCHLORIDE ALLERGY CETIRIZINE HYDROCHLORIDE 10MG TABLET;ORAL Over-the-counter No 209274 GRANULES
CETIRIZINE HYDROCHLORIDE ALLERGY CETIRIZINE HYDROCHLORIDE 10MG TABLET;ORAL Over-the-counter No 202277 IPCA LABS LTD
CETIRIZINE HYDROCHLORIDE ALLERGY CETIRIZINE HYDROCHLORIDE 10MG TABLET;ORAL Over-the-counter No 078933 MARKSANS PHARMA
CETIRIZINE HYDROCHLORIDE ALLERGY CETIRIZINE HYDROCHLORIDE 10MG TABLET;ORAL Over-the-counter No 076677 MYLAN
CETIRIZINE HYDROCHLORIDE ALLERGY CETIRIZINE HYDROCHLORIDE 10MG TABLET;ORAL Over-the-counter No 078862 ORCHID HLTHCARE
CETIRIZINE HYDROCHLORIDE ALLERGY CETIRIZINE HYDROCHLORIDE 10MG TABLET;ORAL Over-the-counter No 078336 PERRIGO R AND D
CETIRIZINE HYDROCHLORIDE ALLERGY CETIRIZINE HYDROCHLORIDE 10MG TABLET;ORAL Over-the-counter No 077946 PLD ACQUISITIONS
CETIRIZINE HYDROCHLORIDE ALLERGY CETIRIZINE HYDROCHLORIDE 10MG TABLET;ORAL Over-the-counter No 077498 SUN PHARM INDS LTD
CETIRIZINE HYDROCHLORIDE ALLERGY CETIRIZINE HYDROCHLORIDE 10MG TABLET;ORAL Over-the-counter No 077829 UNIQUE PHARM LABS
CETIRIZINE HYDROCHLORIDE ALLERGY CETIRIZINE HYDROCHLORIDE 10MG TABLET;ORAL Over-the-counter No 078427 WOCKHARDT
CETIRIZINE HYDROCHLORIDE HIVES CETIRIZINE HYDROCHLORIDE 10MG TABLET;ORAL Over-the-counter No 078343 DR REDDYS LABS LTD
CETIRIZINE HYDROCHLORIDE HIVES CETIRIZINE HYDROCHLORIDE 10MG TABLET;ORAL Over-the-counter No 202277 IPCA LABS LTD
CETIRIZINE HYDROCHLORIDE HIVES CETIRIZINE HYDROCHLORIDE 10MG TABLET;ORAL Over-the-counter No 078933 MARKSANS PHARMA
CETIRIZINE HYDROCHLORIDE HIVES CETIRIZINE HYDROCHLORIDE 10MG TABLET;ORAL Over-the-counter No 076677 MYLAN
CETIRIZINE HYDROCHLORIDE HIVES CETIRIZINE HYDROCHLORIDE 10MG TABLET;ORAL Over-the-counter No 078862 ORCHID HLTHCARE
CETIRIZINE HYDROCHLORIDE HIVES CETIRIZINE HYDROCHLORIDE 10MG TABLET;ORAL Over-the-counter No 078336 PERRIGO R AND D
CETIRIZINE HYDROCHLORIDE HIVES CETIRIZINE HYDROCHLORIDE 10MG TABLET;ORAL Over-the-counter No 077498 SUN PHARM INDS LTD
CETIRIZINE HYDROCHLORIDE HIVES CETIRIZINE HYDROCHLORIDE 10MG TABLET;ORAL Over-the-counter No 077829 UNIQUE PHARM LABS
CETIRIZINE HYDROCHLORIDE HIVES RELIEF CETIRIZINE HYDROCHLORIDE 10MG TABLET;ORAL Over-the-counter No 078780 AMNEAL PHARMS NY
CETIRIZINE HYDROCHLORIDE HIVES RELIEF CETIRIZINE HYDROCHLORIDE 10MG TABLET;ORAL Over-the-counter No 090760 AUROBINDO PHARMA LTD
CETIRIZINE HYDROCHLORIDE HIVES RELIEF CETIRIZINE HYDROCHLORIDE 10MG TABLET;ORAL Over-the-counter No 078072 TARO
ZYRTEC ALLERGY CETIRIZINE HYDROCHLORIDE 10MG TABLET;ORAL Over-the-counter Yes 019835 J AND J CONSUMER INC

CETIRIZINE HYDROCHLORIDE HIVES

The products listed here are over-the-counter (OTC) drugs and do not receive therapeutic equivalence ratings. They may not be interchangeable.

TABLET;ORAL; 5MG
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD Application No. Company
CETIRIZINE HYDROCHLORIDE ALLERGY CETIRIZINE HYDROCHLORIDE 5MG TABLET;ORAL Over-the-counter No 078780 AMNEAL PHARMS NY
CETIRIZINE HYDROCHLORIDE ALLERGY CETIRIZINE HYDROCHLORIDE 5MG TABLET;ORAL Over-the-counter No 078317 APOTEX INC
CETIRIZINE HYDROCHLORIDE ALLERGY CETIRIZINE HYDROCHLORIDE 5MG TABLET;ORAL Over-the-counter No 090760 AUROBINDO PHARMA LTD
CETIRIZINE HYDROCHLORIDE ALLERGY CETIRIZINE HYDROCHLORIDE 5MG TABLET;ORAL Over-the-counter No 076047 CONTRACT PHARMACAL
CETIRIZINE HYDROCHLORIDE ALLERGY CETIRIZINE HYDROCHLORIDE 5MG TABLET;ORAL Over-the-counter No 078343 DR REDDYS LABS LTD
CETIRIZINE HYDROCHLORIDE ALLERGY CETIRIZINE HYDROCHLORIDE 5MG TABLET;ORAL Over-the-counter No 202277 IPCA LABS LTD
CETIRIZINE HYDROCHLORIDE ALLERGY CETIRIZINE HYDROCHLORIDE 5MG TABLET;ORAL Over-the-counter No 078933 MARKSANS PHARMA
CETIRIZINE HYDROCHLORIDE ALLERGY CETIRIZINE HYDROCHLORIDE 5MG TABLET;ORAL Over-the-counter No 076677 MYLAN
CETIRIZINE HYDROCHLORIDE ALLERGY CETIRIZINE HYDROCHLORIDE 5MG TABLET;ORAL Over-the-counter No 078862 ORCHID HLTHCARE
CETIRIZINE HYDROCHLORIDE ALLERGY CETIRIZINE HYDROCHLORIDE 5MG TABLET;ORAL Over-the-counter No 078336 PERRIGO R AND D
CETIRIZINE HYDROCHLORIDE ALLERGY CETIRIZINE HYDROCHLORIDE 5MG TABLET;ORAL Over-the-counter No 077946 PLD ACQUISITIONS
CETIRIZINE HYDROCHLORIDE ALLERGY CETIRIZINE HYDROCHLORIDE 5MG TABLET;ORAL Over-the-counter No 077498 SUN PHARM INDS LTD
CETIRIZINE HYDROCHLORIDE ALLERGY CETIRIZINE HYDROCHLORIDE 5MG TABLET;ORAL Over-the-counter No 078072 TARO
CETIRIZINE HYDROCHLORIDE ALLERGY CETIRIZINE HYDROCHLORIDE 5MG TABLET;ORAL Over-the-counter No 077829 UNIQUE PHARM LABS
CETIRIZINE HYDROCHLORIDE ALLERGY CETIRIZINE HYDROCHLORIDE 5MG TABLET;ORAL Over-the-counter No 078427 WOCKHARDT
CETIRIZINE HYDROCHLORIDE HIVES CETIRIZINE HYDROCHLORIDE 5MG TABLET;ORAL Over-the-counter No 078343 DR REDDYS LABS LTD
CETIRIZINE HYDROCHLORIDE HIVES CETIRIZINE HYDROCHLORIDE 5MG TABLET;ORAL Over-the-counter No 202277 IPCA LABS LTD
CETIRIZINE HYDROCHLORIDE HIVES CETIRIZINE HYDROCHLORIDE 5MG TABLET;ORAL Over-the-counter No 078933 MARKSANS PHARMA
CETIRIZINE HYDROCHLORIDE HIVES CETIRIZINE HYDROCHLORIDE 5MG TABLET;ORAL Over-the-counter No 076677 MYLAN
CETIRIZINE HYDROCHLORIDE HIVES CETIRIZINE HYDROCHLORIDE 5MG TABLET;ORAL Over-the-counter No 078862 ORCHID HLTHCARE
CETIRIZINE HYDROCHLORIDE HIVES CETIRIZINE HYDROCHLORIDE 5MG TABLET;ORAL Over-the-counter No 078336 PERRIGO R AND D
CETIRIZINE HYDROCHLORIDE HIVES CETIRIZINE HYDROCHLORIDE 5MG TABLET;ORAL Over-the-counter No 077498 SUN PHARM INDS LTD
CETIRIZINE HYDROCHLORIDE HIVES CETIRIZINE HYDROCHLORIDE 5MG TABLET;ORAL Over-the-counter No 077829 UNIQUE PHARM LABS
CETIRIZINE HYDROCHLORIDE HIVES RELIEF CETIRIZINE HYDROCHLORIDE 5MG TABLET;ORAL Over-the-counter No 078780 AMNEAL PHARMS NY
CETIRIZINE HYDROCHLORIDE HIVES RELIEF CETIRIZINE HYDROCHLORIDE 5MG TABLET;ORAL Over-the-counter No 090760 AUROBINDO PHARMA LTD

The products listed here are over-the-counter (OTC) drugs and do not receive therapeutic equivalence ratings. They may not be interchangeable.

TABLET;ORAL; 10MG
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD Application No. Company
CETIRIZINE HYDROCHLORIDE ALLERGY CETIRIZINE HYDROCHLORIDE 10MG TABLET;ORAL Over-the-counter No 078780 AMNEAL PHARMS NY
CETIRIZINE HYDROCHLORIDE ALLERGY CETIRIZINE HYDROCHLORIDE 10MG TABLET;ORAL Over-the-counter No 078317 APOTEX INC
CETIRIZINE HYDROCHLORIDE ALLERGY CETIRIZINE HYDROCHLORIDE 10MG TABLET;ORAL Over-the-counter No 090760 AUROBINDO PHARMA LTD
CETIRIZINE HYDROCHLORIDE ALLERGY CETIRIZINE HYDROCHLORIDE 10MG TABLET;ORAL Over-the-counter No 076047 CONTRACT PHARMACAL
CETIRIZINE HYDROCHLORIDE ALLERGY CETIRIZINE HYDROCHLORIDE 10MG TABLET;ORAL Over-the-counter No 078343 DR REDDYS LABS LTD
CETIRIZINE HYDROCHLORIDE ALLERGY CETIRIZINE HYDROCHLORIDE 10MG TABLET;ORAL Over-the-counter No 209274 GRANULES
CETIRIZINE HYDROCHLORIDE ALLERGY CETIRIZINE HYDROCHLORIDE 10MG TABLET;ORAL Over-the-counter No 202277 IPCA LABS LTD
CETIRIZINE HYDROCHLORIDE ALLERGY CETIRIZINE HYDROCHLORIDE 10MG TABLET;ORAL Over-the-counter No 078933 MARKSANS PHARMA
CETIRIZINE HYDROCHLORIDE ALLERGY CETIRIZINE HYDROCHLORIDE 10MG TABLET;ORAL Over-the-counter No 076677 MYLAN
CETIRIZINE HYDROCHLORIDE ALLERGY CETIRIZINE HYDROCHLORIDE 10MG TABLET;ORAL Over-the-counter No 078862 ORCHID HLTHCARE
CETIRIZINE HYDROCHLORIDE ALLERGY CETIRIZINE HYDROCHLORIDE 10MG TABLET;ORAL Over-the-counter No 078336 PERRIGO R AND D
CETIRIZINE HYDROCHLORIDE ALLERGY CETIRIZINE HYDROCHLORIDE 10MG TABLET;ORAL Over-the-counter No 077946 PLD ACQUISITIONS
CETIRIZINE HYDROCHLORIDE ALLERGY CETIRIZINE HYDROCHLORIDE 10MG TABLET;ORAL Over-the-counter No 077498 SUN PHARM INDS LTD
CETIRIZINE HYDROCHLORIDE ALLERGY CETIRIZINE HYDROCHLORIDE 10MG TABLET;ORAL Over-the-counter No 077829 UNIQUE PHARM LABS
CETIRIZINE HYDROCHLORIDE ALLERGY CETIRIZINE HYDROCHLORIDE 10MG TABLET;ORAL Over-the-counter No 078427 WOCKHARDT
CETIRIZINE HYDROCHLORIDE HIVES CETIRIZINE HYDROCHLORIDE 10MG TABLET;ORAL Over-the-counter No 078343 DR REDDYS LABS LTD
CETIRIZINE HYDROCHLORIDE HIVES CETIRIZINE HYDROCHLORIDE 10MG TABLET;ORAL Over-the-counter No 202277 IPCA LABS LTD
CETIRIZINE HYDROCHLORIDE HIVES CETIRIZINE HYDROCHLORIDE 10MG TABLET;ORAL Over-the-counter No 078933 MARKSANS PHARMA
CETIRIZINE HYDROCHLORIDE HIVES CETIRIZINE HYDROCHLORIDE 10MG TABLET;ORAL Over-the-counter No 076677 MYLAN
CETIRIZINE HYDROCHLORIDE HIVES CETIRIZINE HYDROCHLORIDE 10MG TABLET;ORAL Over-the-counter No 078862 ORCHID HLTHCARE
CETIRIZINE HYDROCHLORIDE HIVES CETIRIZINE HYDROCHLORIDE 10MG TABLET;ORAL Over-the-counter No 078336 PERRIGO R AND D
CETIRIZINE HYDROCHLORIDE HIVES CETIRIZINE HYDROCHLORIDE 10MG TABLET;ORAL Over-the-counter No 077498 SUN PHARM INDS LTD
CETIRIZINE HYDROCHLORIDE HIVES CETIRIZINE HYDROCHLORIDE 10MG TABLET;ORAL Over-the-counter No 077829 UNIQUE PHARM LABS
CETIRIZINE HYDROCHLORIDE HIVES RELIEF CETIRIZINE HYDROCHLORIDE 10MG TABLET;ORAL Over-the-counter No 078780 AMNEAL PHARMS NY
CETIRIZINE HYDROCHLORIDE HIVES RELIEF CETIRIZINE HYDROCHLORIDE 10MG TABLET;ORAL Over-the-counter No 090760 AUROBINDO PHARMA LTD
CETIRIZINE HYDROCHLORIDE HIVES RELIEF CETIRIZINE HYDROCHLORIDE 10MG TABLET;ORAL Over-the-counter No 078072 TARO
ZYRTEC ALLERGY CETIRIZINE HYDROCHLORIDE 10MG TABLET;ORAL Over-the-counter Yes 019835 J AND J CONSUMER INC
بخوانید  CETIRIZINE HYDROCHLORIDE ALLERGY از شرکت DR REDDYS LABS LTD
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