Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 076502
Company: DR REDDYS LABS LTD
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 FEXOFENADINE HYDROCHLORIDE 30MG TABLET;ORAL Prescription AB No No
FEXOFENADINE HYDROCHLORIDE FEXOFENADINE HYDROCHLORIDE 60MG TABLET;ORAL Prescription AB No No
FEXOFENADINE HYDROCHLORIDE FEXOFENADINE HYDROCHLORIDE 180MG TABLET;ORAL Prescription AB 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
04/11/2006 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
01/02/2013 SUPPL-9 Labeling-Container/Carton Labels

Label is not available on this site.

09/23/2011 SUPPL-8 Labeling-Package Insert

Label is not available on this site.

04/12/2011 SUPPL-7 Labeling-Container/Carton Labels

Label is not available on this site.

01/14/2009 SUPPL-2 Labeling

Label is not available on this site.

CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY

There are no Therapeutic Equivalents.

CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES

There are no Therapeutic Equivalents.

FEXOFENADINE HYDROCHLORIDE

TABLET;ORAL; 30MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
FEXOFENADINE HYDROCHLORIDE FEXOFENADINE HYDROCHLORIDE 30MG TABLET;ORAL Prescription No AB 076191 BARR
FEXOFENADINE HYDROCHLORIDE FEXOFENADINE HYDROCHLORIDE 30MG TABLET;ORAL Prescription No AB 076502 DR REDDYS LABS LTD
FEXOFENADINE HYDROCHLORIDE FEXOFENADINE HYDROCHLORIDE 30MG TABLET;ORAL Prescription No AB 076447 TEVA

TABLET;ORAL; 60MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
FEXOFENADINE HYDROCHLORIDE FEXOFENADINE HYDROCHLORIDE 60MG TABLET;ORAL Prescription No AB 076191 BARR
FEXOFENADINE HYDROCHLORIDE FEXOFENADINE HYDROCHLORIDE 60MG TABLET;ORAL Prescription No AB 076502 DR REDDYS LABS LTD
FEXOFENADINE HYDROCHLORIDE FEXOFENADINE HYDROCHLORIDE 60MG TABLET;ORAL Prescription No AB 077081 MYLAN
FEXOFENADINE HYDROCHLORIDE FEXOFENADINE HYDROCHLORIDE 60MG TABLET;ORAL Prescription No AB 076447 TEVA

TABLET;ORAL; 180MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
FEXOFENADINE HYDROCHLORIDE FEXOFENADINE HYDROCHLORIDE 180MG TABLET;ORAL Prescription No AB 076191 BARR
FEXOFENADINE HYDROCHLORIDE FEXOFENADINE HYDROCHLORIDE 180MG TABLET;ORAL Prescription No AB 076502 DR REDDYS LABS LTD
FEXOFENADINE HYDROCHLORIDE FEXOFENADINE HYDROCHLORIDE 180MG TABLET;ORAL Prescription No AB 077081 MYLAN
FEXOFENADINE HYDROCHLORIDE FEXOFENADINE HYDROCHLORIDE 180MG TABLET;ORAL Prescription No AB 076447 TEVA

FEXOFENADINE HYDROCHLORIDE ALLERGY

There are no Therapeutic Equivalents.

FEXOFENADINE HYDROCHLORIDE HIVES

There are no Therapeutic Equivalents.

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

There are no other OTC drugs with the same Active Ingredient, Strength and Dosage Form/Route.

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 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 INDIA LTD
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 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 INDIA LTD
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 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 INDIA LTD
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 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 INDIA LTD
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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