Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 091305
Company: INVAGEN PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
NAPROXEN NAPROXEN 250MG TABLET;ORAL Prescription AB No No
NAPROXEN NAPROXEN 375MG TABLET;ORAL Prescription AB No No
NAPROXEN NAPROXEN 500MG TABLET;ORAL Prescription AB 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
08/24/2011 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
08/03/2016 SUPPL-6 Labeling-Package Insert

Label is not available on this site.

08/03/2016 SUPPL-5 Labeling-Package Insert

Label is not available on this site.

NAPROXEN

TABLET;ORAL; 250MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
NAPROXEN NAPROXEN 250MG TABLET;ORAL Prescription No AB 075927 AMNEAL PHARMS NY
NAPROXEN NAPROXEN 250MG TABLET;ORAL Prescription No AB 200429 AUROBINDO PHARMA LTD
NAPROXEN NAPROXEN 250MG TABLET;ORAL Prescription No AB 078250 GLENMARK GENERICS
NAPROXEN NAPROXEN 250MG TABLET;ORAL Prescription No AB 091305 INVAGEN PHARMS
NAPROXEN NAPROXEN 250MG TABLET;ORAL Prescription No AB 091416 MARKSANS PHARMA
NAPROXEN NAPROXEN 250MG TABLET;ORAL Prescription No AB 074121 MYLAN
NAPROXEN NAPROXEN 250MG TABLET;ORAL Prescription No AB 077339 PERRIGO R AND D
NAPROXEN NAPROXEN 250MG TABLET;ORAL Prescription No AB 074201 TEVA
NAPROXEN NAPROXEN 250MG TABLET;ORAL Prescription No AB 078620 ZYDUS PHARMS USA

TABLET;ORAL; 375MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
NAPROXEN NAPROXEN 375MG TABLET;ORAL Prescription No AB 075927 AMNEAL PHARMS NY
NAPROXEN NAPROXEN 375MG TABLET;ORAL Prescription No AB 200429 AUROBINDO PHARMA LTD
NAPROXEN NAPROXEN 375MG TABLET;ORAL Prescription No AB 078250 GLENMARK GENERICS
NAPROXEN NAPROXEN 375MG TABLET;ORAL Prescription No AB 091305 INVAGEN PHARMS
NAPROXEN NAPROXEN 375MG TABLET;ORAL Prescription No AB 091416 MARKSANS PHARMA
NAPROXEN NAPROXEN 375MG TABLET;ORAL Prescription No AB 074121 MYLAN
NAPROXEN NAPROXEN 375MG TABLET;ORAL Prescription No AB 077339 PERRIGO R AND D
NAPROXEN NAPROXEN 375MG TABLET;ORAL Prescription No AB 074201 TEVA
NAPROXEN NAPROXEN 375MG TABLET;ORAL Prescription No AB 078620 ZYDUS PHARMS USA

TABLET;ORAL; 500MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
NAPROSYN NAPROXEN 500MG TABLET;ORAL Prescription Yes AB 017581 ATNAHS PHARMA US
NAPROXEN NAPROXEN 500MG TABLET;ORAL Prescription No AB 075927 AMNEAL PHARMS NY
NAPROXEN NAPROXEN 500MG TABLET;ORAL Prescription No AB 200429 AUROBINDO PHARMA LTD
NAPROXEN NAPROXEN 500MG TABLET;ORAL Prescription No AB 078250 GLENMARK GENERICS
NAPROXEN NAPROXEN 500MG TABLET;ORAL Prescription No AB 091305 INVAGEN PHARMS
NAPROXEN NAPROXEN 500MG TABLET;ORAL Prescription No AB 091416 MARKSANS PHARMA
NAPROXEN NAPROXEN 500MG TABLET;ORAL Prescription No AB 074121 MYLAN
NAPROXEN NAPROXEN 500MG TABLET;ORAL Prescription No AB 077339 PERRIGO R AND D
NAPROXEN NAPROXEN 500MG TABLET;ORAL Prescription No AB 074201 TEVA
NAPROXEN NAPROXEN 500MG TABLET;ORAL Prescription No AB 078620 ZYDUS PHARMS USA

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