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CHILDREN’S FEXOFENADINE HYDROCHLORIDE ALLERGY از شرکت SUN PHARM INDS

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CHILDREN’S FEXOFENADINE HYDROCHLORIDE ALLERGY از شرکت SUN PHARM INDS

Abbreviated New Drug Application (ANDA): 091567

Company: SUN PHARM INDS

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CHILDREN’S FEXOFENADINE HYDROCHLORIDE ALLERGY FEXOFENADINE HYDROCHLORIDE 30MG TABLET;ORAL Over-the-counter

None

No No
CHILDREN’S FEXOFENADINE HYDROCHLORIDE HIVES FEXOFENADINE HYDROCHLORIDE 30MG TABLET;ORAL Over-the-counter

None

No No
FEXOFENADINE HYDROCHLORIDE ALLERGY FEXOFENADINE HYDROCHLORIDE 60MG TABLET;ORAL Over-the-counter

None

No No
FEXOFENADINE HYDROCHLORIDE ALLERGY FEXOFENADINE HYDROCHLORIDE 180MG TABLET;ORAL Over-the-counter

None

No No
FEXOFENADINE HYDROCHLORIDE HIVES FEXOFENADINE HYDROCHLORIDE 60MG TABLET;ORAL Over-the-counter

None

No No
FEXOFENADINE HYDROCHLORIDE HIVES FEXOFENADINE HYDROCHLORIDE 180MG 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
02/06/2012 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
02/25/2015 SUPPL-1 Labeling-Container/Carton Labels

Label is not available on this site.

CHILDREN’S FEXOFENADINE 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; 30MG
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD Application No. Company
CHILDREN’S FEXOFENADINE HYDROCHLORIDE ALLERGY FEXOFENADINE HYDROCHLORIDE 30MG TABLET;ORAL Over-the-counter No 202039 AUROLIFE PHARMA LLC
CHILDREN’S FEXOFENADINE HYDROCHLORIDE ALLERGY FEXOFENADINE HYDROCHLORIDE 30MG TABLET;ORAL Over-the-counter No 076502 DR REDDYS LABS LTD
CHILDREN’S FEXOFENADINE HYDROCHLORIDE ALLERGY FEXOFENADINE HYDROCHLORIDE 30MG TABLET;ORAL Over-the-counter No 204097 HETERO LABS LTD V
CHILDREN’S FEXOFENADINE HYDROCHLORIDE ALLERGY FEXOFENADINE HYDROCHLORIDE 30MG TABLET;ORAL Over-the-counter No 091567 SUN PHARM INDS
CHILDREN’S FEXOFENADINE HYDROCHLORIDE ALLERGY FEXOFENADINE HYDROCHLORIDE 30MG TABLET;ORAL Over-the-counter No 076447 TEVA
CHILDREN’S FEXOFENADINE HYDROCHLORIDE ALLERGY FEXOFENADINE HYDROCHLORIDE 30MG TABLET;ORAL Over-the-counter No 079112 WOCKHARDT LTD
CHILDREN’S FEXOFENADINE HYDROCHLORIDE HIVES FEXOFENADINE HYDROCHLORIDE 30MG TABLET;ORAL Over-the-counter No 076502 DR REDDYS LABS LTD
CHILDREN’S FEXOFENADINE HYDROCHLORIDE HIVES FEXOFENADINE HYDROCHLORIDE 30MG TABLET;ORAL Over-the-counter No 091567 SUN PHARM INDS
CHILDREN’S FEXOFENADINE HYDROCHLORIDE HIVES FEXOFENADINE HYDROCHLORIDE 30MG TABLET;ORAL Over-the-counter No 076447 TEVA
CHILDREN’S FEXOFENADINE HYDROCHLORIDE HIVES FEXOFENADINE HYDROCHLORIDE 30MG TABLET;ORAL Over-the-counter No 079112 WOCKHARDT LTD

CHILDREN’S FEXOFENADINE 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; 30MG
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD Application No. Company
CHILDREN’S FEXOFENADINE HYDROCHLORIDE ALLERGY FEXOFENADINE HYDROCHLORIDE 30MG TABLET;ORAL Over-the-counter No 202039 AUROLIFE PHARMA LLC
CHILDREN’S FEXOFENADINE HYDROCHLORIDE ALLERGY FEXOFENADINE HYDROCHLORIDE 30MG TABLET;ORAL Over-the-counter No 076502 DR REDDYS LABS LTD
CHILDREN’S FEXOFENADINE HYDROCHLORIDE ALLERGY FEXOFENADINE HYDROCHLORIDE 30MG TABLET;ORAL Over-the-counter No 204097 HETERO LABS LTD V
CHILDREN’S FEXOFENADINE HYDROCHLORIDE ALLERGY FEXOFENADINE HYDROCHLORIDE 30MG TABLET;ORAL Over-the-counter No 091567 SUN PHARM INDS
CHILDREN’S FEXOFENADINE HYDROCHLORIDE ALLERGY FEXOFENADINE HYDROCHLORIDE 30MG TABLET;ORAL Over-the-counter No 076447 TEVA
CHILDREN’S FEXOFENADINE HYDROCHLORIDE ALLERGY FEXOFENADINE HYDROCHLORIDE 30MG TABLET;ORAL Over-the-counter No 079112 WOCKHARDT LTD
CHILDREN’S FEXOFENADINE HYDROCHLORIDE HIVES FEXOFENADINE HYDROCHLORIDE 30MG TABLET;ORAL Over-the-counter No 076502 DR REDDYS LABS LTD
CHILDREN’S FEXOFENADINE HYDROCHLORIDE HIVES FEXOFENADINE HYDROCHLORIDE 30MG TABLET;ORAL Over-the-counter No 091567 SUN PHARM INDS
CHILDREN’S FEXOFENADINE HYDROCHLORIDE HIVES FEXOFENADINE HYDROCHLORIDE 30MG TABLET;ORAL Over-the-counter No 076447 TEVA
CHILDREN’S FEXOFENADINE HYDROCHLORIDE HIVES FEXOFENADINE HYDROCHLORIDE 30MG TABLET;ORAL Over-the-counter No 079112 WOCKHARDT LTD

FEXOFENADINE 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; 60MG
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD Application No. Company
ALLEGRA ALLERGY FEXOFENADINE HYDROCHLORIDE 60MG TABLET;ORAL Over-the-counter Yes 020872 SANOFI AVENTIS US
FEXOFENADINE HYDROCHLORIDE FEXOFENADINE HYDROCHLORIDE 60MG TABLET;ORAL Over-the-counter No 212971 L PERRIGO CO
FEXOFENADINE HYDROCHLORIDE ALLERGY FEXOFENADINE HYDROCHLORIDE 60MG TABLET;ORAL Over-the-counter No 202039 AUROLIFE PHARMA LLC
FEXOFENADINE HYDROCHLORIDE ALLERGY FEXOFENADINE HYDROCHLORIDE 60MG TABLET;ORAL Over-the-counter No 076502 DR REDDYS LABS LTD
FEXOFENADINE HYDROCHLORIDE ALLERGY FEXOFENADINE HYDROCHLORIDE 60MG TABLET;ORAL Over-the-counter No 211075 GRANULES
FEXOFENADINE HYDROCHLORIDE ALLERGY FEXOFENADINE HYDROCHLORIDE 60MG TABLET;ORAL Over-the-counter No 204097 HETERO LABS LTD V
FEXOFENADINE HYDROCHLORIDE ALLERGY FEXOFENADINE HYDROCHLORIDE 60MG TABLET;ORAL Over-the-counter No 077081 MYLAN
FEXOFENADINE HYDROCHLORIDE ALLERGY FEXOFENADINE HYDROCHLORIDE 60MG TABLET;ORAL Over-the-counter No 204507 SCIEGEN PHARMS INC
FEXOFENADINE HYDROCHLORIDE ALLERGY FEXOFENADINE HYDROCHLORIDE 60MG TABLET;ORAL Over-the-counter No 091567 SUN PHARM INDS
FEXOFENADINE HYDROCHLORIDE ALLERGY FEXOFENADINE HYDROCHLORIDE 60MG TABLET;ORAL Over-the-counter No 076447 TEVA
FEXOFENADINE HYDROCHLORIDE ALLERGY FEXOFENADINE HYDROCHLORIDE 60MG TABLET;ORAL Over-the-counter No 079112 WOCKHARDT LTD
FEXOFENADINE HYDROCHLORIDE HIVES FEXOFENADINE HYDROCHLORIDE 60MG TABLET;ORAL Over-the-counter No 076502 DR REDDYS LABS LTD
FEXOFENADINE HYDROCHLORIDE HIVES FEXOFENADINE HYDROCHLORIDE 60MG TABLET;ORAL Over-the-counter No 077081 MYLAN
FEXOFENADINE HYDROCHLORIDE HIVES FEXOFENADINE HYDROCHLORIDE 60MG TABLET;ORAL Over-the-counter No 204507 SCIEGEN PHARMS INC
FEXOFENADINE HYDROCHLORIDE HIVES FEXOFENADINE HYDROCHLORIDE 60MG TABLET;ORAL Over-the-counter No 091567 SUN PHARM INDS
FEXOFENADINE HYDROCHLORIDE HIVES FEXOFENADINE HYDROCHLORIDE 60MG TABLET;ORAL Over-the-counter No 076447 TEVA
FEXOFENADINE HYDROCHLORIDE HIVES FEXOFENADINE HYDROCHLORIDE 60MG TABLET;ORAL Over-the-counter No 079112 WOCKHARDT 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; 180MG
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD Application No. Company
ALLEGRA ALLERGY FEXOFENADINE HYDROCHLORIDE 180MG TABLET;ORAL Over-the-counter Yes 020872 SANOFI AVENTIS US
FEXOFENADINE HYDROCHLORIDE FEXOFENADINE HYDROCHLORIDE 180MG TABLET;ORAL Over-the-counter No 212971 L PERRIGO CO
FEXOFENADINE HYDROCHLORIDE ALLERGY FEXOFENADINE HYDROCHLORIDE 180MG TABLET;ORAL Over-the-counter No 202039 AUROLIFE PHARMA LLC
FEXOFENADINE HYDROCHLORIDE ALLERGY FEXOFENADINE HYDROCHLORIDE 180MG TABLET;ORAL Over-the-counter No 076502 DR REDDYS LABS LTD
FEXOFENADINE HYDROCHLORIDE ALLERGY FEXOFENADINE HYDROCHLORIDE 180MG TABLET;ORAL Over-the-counter No 211075 GRANULES
FEXOFENADINE HYDROCHLORIDE ALLERGY FEXOFENADINE HYDROCHLORIDE 180MG TABLET;ORAL Over-the-counter No 204097 HETERO LABS LTD V
FEXOFENADINE HYDROCHLORIDE ALLERGY FEXOFENADINE HYDROCHLORIDE 180MG TABLET;ORAL Over-the-counter No 077081 MYLAN
FEXOFENADINE HYDROCHLORIDE ALLERGY FEXOFENADINE HYDROCHLORIDE 180MG TABLET;ORAL Over-the-counter No 204507 SCIEGEN PHARMS INC
FEXOFENADINE HYDROCHLORIDE ALLERGY FEXOFENADINE HYDROCHLORIDE 180MG TABLET;ORAL Over-the-counter No 091567 SUN PHARM INDS
FEXOFENADINE HYDROCHLORIDE ALLERGY FEXOFENADINE HYDROCHLORIDE 180MG TABLET;ORAL Over-the-counter No 076447 TEVA
FEXOFENADINE HYDROCHLORIDE ALLERGY FEXOFENADINE HYDROCHLORIDE 180MG TABLET;ORAL Over-the-counter No 210137 UNIQUE PHARM LABS
FEXOFENADINE HYDROCHLORIDE ALLERGY FEXOFENADINE HYDROCHLORIDE 180MG TABLET;ORAL Over-the-counter No 079112 WOCKHARDT LTD
FEXOFENADINE HYDROCHLORIDE HIVES FEXOFENADINE HYDROCHLORIDE 180MG TABLET;ORAL Over-the-counter No 076502 DR REDDYS LABS LTD
FEXOFENADINE HYDROCHLORIDE HIVES FEXOFENADINE HYDROCHLORIDE 180MG TABLET;ORAL Over-the-counter No 077081 MYLAN
FEXOFENADINE HYDROCHLORIDE HIVES FEXOFENADINE HYDROCHLORIDE 180MG TABLET;ORAL Over-the-counter No 204507 SCIEGEN PHARMS INC
FEXOFENADINE HYDROCHLORIDE HIVES FEXOFENADINE HYDROCHLORIDE 180MG TABLET;ORAL Over-the-counter No 091567 SUN PHARM INDS
FEXOFENADINE HYDROCHLORIDE HIVES FEXOFENADINE HYDROCHLORIDE 180MG TABLET;ORAL Over-the-counter No 076447 TEVA
FEXOFENADINE HYDROCHLORIDE HIVES FEXOFENADINE HYDROCHLORIDE 180MG TABLET;ORAL Over-the-counter No 079112 WOCKHARDT LTD

FEXOFENADINE 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; 60MG
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD Application No. Company
ALLEGRA ALLERGY FEXOFENADINE HYDROCHLORIDE 60MG TABLET;ORAL Over-the-counter Yes 020872 SANOFI AVENTIS US
FEXOFENADINE HYDROCHLORIDE FEXOFENADINE HYDROCHLORIDE 60MG TABLET;ORAL Over-the-counter No 212971 L PERRIGO CO
FEXOFENADINE HYDROCHLORIDE ALLERGY FEXOFENADINE HYDROCHLORIDE 60MG TABLET;ORAL Over-the-counter No 202039 AUROLIFE PHARMA LLC
FEXOFENADINE HYDROCHLORIDE ALLERGY FEXOFENADINE HYDROCHLORIDE 60MG TABLET;ORAL Over-the-counter No 076502 DR REDDYS LABS LTD
FEXOFENADINE HYDROCHLORIDE ALLERGY FEXOFENADINE HYDROCHLORIDE 60MG TABLET;ORAL Over-the-counter No 211075 GRANULES
FEXOFENADINE HYDROCHLORIDE ALLERGY FEXOFENADINE HYDROCHLORIDE 60MG TABLET;ORAL Over-the-counter No 204097 HETERO LABS LTD V
FEXOFENADINE HYDROCHLORIDE ALLERGY FEXOFENADINE HYDROCHLORIDE 60MG TABLET;ORAL Over-the-counter No 077081 MYLAN
FEXOFENADINE HYDROCHLORIDE ALLERGY FEXOFENADINE HYDROCHLORIDE 60MG TABLET;ORAL Over-the-counter No 204507 SCIEGEN PHARMS INC
FEXOFENADINE HYDROCHLORIDE ALLERGY FEXOFENADINE HYDROCHLORIDE 60MG TABLET;ORAL Over-the-counter No 091567 SUN PHARM INDS
FEXOFENADINE HYDROCHLORIDE ALLERGY FEXOFENADINE HYDROCHLORIDE 60MG TABLET;ORAL Over-the-counter No 076447 TEVA
FEXOFENADINE HYDROCHLORIDE ALLERGY FEXOFENADINE HYDROCHLORIDE 60MG TABLET;ORAL Over-the-counter No 079112 WOCKHARDT LTD
FEXOFENADINE HYDROCHLORIDE HIVES FEXOFENADINE HYDROCHLORIDE 60MG TABLET;ORAL Over-the-counter No 076502 DR REDDYS LABS LTD
FEXOFENADINE HYDROCHLORIDE HIVES FEXOFENADINE HYDROCHLORIDE 60MG TABLET;ORAL Over-the-counter No 077081 MYLAN
FEXOFENADINE HYDROCHLORIDE HIVES FEXOFENADINE HYDROCHLORIDE 60MG TABLET;ORAL Over-the-counter No 204507 SCIEGEN PHARMS INC
FEXOFENADINE HYDROCHLORIDE HIVES FEXOFENADINE HYDROCHLORIDE 60MG TABLET;ORAL Over-the-counter No 091567 SUN PHARM INDS
FEXOFENADINE HYDROCHLORIDE HIVES FEXOFENADINE HYDROCHLORIDE 60MG TABLET;ORAL Over-the-counter No 076447 TEVA
FEXOFENADINE HYDROCHLORIDE HIVES FEXOFENADINE HYDROCHLORIDE 60MG TABLET;ORAL Over-the-counter No 079112 WOCKHARDT 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; 180MG
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD Application No. Company
ALLEGRA ALLERGY FEXOFENADINE HYDROCHLORIDE 180MG TABLET;ORAL Over-the-counter Yes 020872 SANOFI AVENTIS US
FEXOFENADINE HYDROCHLORIDE FEXOFENADINE HYDROCHLORIDE 180MG TABLET;ORAL Over-the-counter No 212971 L PERRIGO CO
FEXOFENADINE HYDROCHLORIDE ALLERGY FEXOFENADINE HYDROCHLORIDE 180MG TABLET;ORAL Over-the-counter No 202039 AUROLIFE PHARMA LLC
FEXOFENADINE HYDROCHLORIDE ALLERGY FEXOFENADINE HYDROCHLORIDE 180MG TABLET;ORAL Over-the-counter No 076502 DR REDDYS LABS LTD
FEXOFENADINE HYDROCHLORIDE ALLERGY FEXOFENADINE HYDROCHLORIDE 180MG TABLET;ORAL Over-the-counter No 211075 GRANULES
FEXOFENADINE HYDROCHLORIDE ALLERGY FEXOFENADINE HYDROCHLORIDE 180MG TABLET;ORAL Over-the-counter No 204097 HETERO LABS LTD V
FEXOFENADINE HYDROCHLORIDE ALLERGY FEXOFENADINE HYDROCHLORIDE 180MG TABLET;ORAL Over-the-counter No 077081 MYLAN
FEXOFENADINE HYDROCHLORIDE ALLERGY FEXOFENADINE HYDROCHLORIDE 180MG TABLET;ORAL Over-the-counter No 204507 SCIEGEN PHARMS INC
FEXOFENADINE HYDROCHLORIDE ALLERGY FEXOFENADINE HYDROCHLORIDE 180MG TABLET;ORAL Over-the-counter No 091567 SUN PHARM INDS
FEXOFENADINE HYDROCHLORIDE ALLERGY FEXOFENADINE HYDROCHLORIDE 180MG TABLET;ORAL Over-the-counter No 076447 TEVA
FEXOFENADINE HYDROCHLORIDE ALLERGY FEXOFENADINE HYDROCHLORIDE 180MG TABLET;ORAL Over-the-counter No 210137 UNIQUE PHARM LABS
FEXOFENADINE HYDROCHLORIDE ALLERGY FEXOFENADINE HYDROCHLORIDE 180MG TABLET;ORAL Over-the-counter No 079112 WOCKHARDT LTD
FEXOFENADINE HYDROCHLORIDE HIVES FEXOFENADINE HYDROCHLORIDE 180MG TABLET;ORAL Over-the-counter No 076502 DR REDDYS LABS LTD
FEXOFENADINE HYDROCHLORIDE HIVES FEXOFENADINE HYDROCHLORIDE 180MG TABLET;ORAL Over-the-counter No 077081 MYLAN
FEXOFENADINE HYDROCHLORIDE HIVES FEXOFENADINE HYDROCHLORIDE 180MG TABLET;ORAL Over-the-counter No 204507 SCIEGEN PHARMS INC
FEXOFENADINE HYDROCHLORIDE HIVES FEXOFENADINE HYDROCHLORIDE 180MG TABLET;ORAL Over-the-counter No 091567 SUN PHARM INDS
FEXOFENADINE HYDROCHLORIDE HIVES FEXOFENADINE HYDROCHLORIDE 180MG TABLET;ORAL Over-the-counter No 076447 TEVA
FEXOFENADINE HYDROCHLORIDE HIVES FEXOFENADINE HYDROCHLORIDE 180MG TABLET;ORAL Over-the-counter No 079112 WOCKHARDT LTD
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