CETIRIZINE HYDROCHLORIDE ALLERGY از شرکت BIONPHARMA INC

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 BIONPHARMA INC

New Drug Application (NDA): 022429

Company: BIONPHARMA INC

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

None

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

None

Yes Yes
CETIRIZINE HYDROCHLORIDE HIVES RELIEF CETIRIZINE HYDROCHLORIDE 10MG CAPSULE;ORAL Over-the-counter

None

Yes Yes
CETIRIZINE HYDROCHLORIDE HIVES RELIEF CETIRIZINE HYDROCHLORIDE 5MG CAPSULE;ORAL Over-the-counter

None

Yes 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
07/23/2009 ORIG-1 Approval

Type 3 – New Dosage Form

STANDARD

Review

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022429_cetirizine_hydrochloride_toc.cfm

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
12/07/2020 SUPPL-17 Labeling-Container/Carton Labels

Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/022429Orig1s017ltr.pdf

12/13/2019 SUPPL-14 Labeling-Container/Carton Labels

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022429Orig1s014lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/022429Orig1s014ltr.pdf

02/06/2013 SUPPL-9 Labeling-Container/Carton Labels

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022429Orig1s009lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022429Orig1s009ltr.pdf

04/06/2010 SUPPL-3 Manufacturing (CMC)

Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022429s003ltr.pdf

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
12/13/2019 SUPPL-14

Labeling-Container/Carton Labels

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022429Orig1s014lbl.pdf
02/06/2013 SUPPL-9

Labeling-Container/Carton Labels

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022429Orig1s009lbl.pdf

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.

CAPSULE;ORAL; 5MG
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD Application No. Company
CETIRIZINE HYDROCHLORIDE ALLERGY CETIRIZINE HYDROCHLORIDE 5MG CAPSULE;ORAL Over-the-counter Yes 022429 BIONPHARMA INC
CETIRIZINE HYDROCHLORIDE HIVES RELIEF CETIRIZINE HYDROCHLORIDE 5MG CAPSULE;ORAL Over-the-counter Yes 022429 BIONPHARMA INC

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

CAPSULE;ORAL; 10MG
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD Application No. Company
CETIRIZINE HYDROCHLORIDE ALLERGY CETIRIZINE HYDROCHLORIDE 10MG CAPSULE;ORAL Over-the-counter No 207235 APOTEX
CETIRIZINE HYDROCHLORIDE ALLERGY CETIRIZINE HYDROCHLORIDE 10MG CAPSULE;ORAL Over-the-counter No 209107 AUROBINDO PHARMA LTD
CETIRIZINE HYDROCHLORIDE ALLERGY CETIRIZINE HYDROCHLORIDE 10MG CAPSULE;ORAL Over-the-counter Yes 022429 BIONPHARMA INC
CETIRIZINE HYDROCHLORIDE ALLERGY CETIRIZINE HYDROCHLORIDE 10MG CAPSULE;ORAL Over-the-counter No 205291 STRIDES PHARMA
CETIRIZINE HYDROCHLORIDE HIVES RELIEF CETIRIZINE HYDROCHLORIDE 10MG CAPSULE;ORAL Over-the-counter No 209107 AUROBINDO PHARMA LTD
CETIRIZINE HYDROCHLORIDE HIVES RELIEF CETIRIZINE HYDROCHLORIDE 10MG CAPSULE;ORAL Over-the-counter Yes 022429 BIONPHARMA INC

CETIRIZINE HYDROCHLORIDE HIVES RELIEF

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

CAPSULE;ORAL; 5MG
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD Application No. Company
CETIRIZINE HYDROCHLORIDE ALLERGY CETIRIZINE HYDROCHLORIDE 5MG CAPSULE;ORAL Over-the-counter Yes 022429 BIONPHARMA INC
CETIRIZINE HYDROCHLORIDE HIVES RELIEF CETIRIZINE HYDROCHLORIDE 5MG CAPSULE;ORAL Over-the-counter Yes 022429 BIONPHARMA INC

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

CAPSULE;ORAL; 10MG
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD Application No. Company
CETIRIZINE HYDROCHLORIDE ALLERGY CETIRIZINE HYDROCHLORIDE 10MG CAPSULE;ORAL Over-the-counter No 207235 APOTEX
CETIRIZINE HYDROCHLORIDE ALLERGY CETIRIZINE HYDROCHLORIDE 10MG CAPSULE;ORAL Over-the-counter No 209107 AUROBINDO PHARMA LTD
CETIRIZINE HYDROCHLORIDE ALLERGY CETIRIZINE HYDROCHLORIDE 10MG CAPSULE;ORAL Over-the-counter Yes 022429 BIONPHARMA INC
CETIRIZINE HYDROCHLORIDE ALLERGY CETIRIZINE HYDROCHLORIDE 10MG CAPSULE;ORAL Over-the-counter No 205291 STRIDES PHARMA
CETIRIZINE HYDROCHLORIDE HIVES RELIEF CETIRIZINE HYDROCHLORIDE 10MG CAPSULE;ORAL Over-the-counter No 209107 AUROBINDO PHARMA LTD
CETIRIZINE HYDROCHLORIDE HIVES RELIEF CETIRIZINE HYDROCHLORIDE 10MG CAPSULE;ORAL Over-the-counter Yes 022429 BIONPHARMA INC
بخوانید  BROMPHENIRAMINE MALEATE از شرکت NEXGEN PHARMA INC
به بالای صفحه بردن