Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 091432
Company: INVAGEN PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
NAPROXEN NAPROXEN 375MG TABLET, DELAYED RELEASE;ORAL Prescription AB No No
NAPROXEN NAPROXEN 500MG TABLET, DELAYED RELEASE;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
09/19/2011 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
05/04/2015 SUPPL-2 Labeling-Patient Package Insert, Labeling-Package Insert

Label is not available on this site.

NAPROXEN

TABLET, DELAYED RELEASE;ORAL; 375MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
EC-NAPROSYN NAPROXEN 375MG TABLET, DELAYED RELEASE;ORAL Prescription Yes AB 020067 ATNAHS PHARMA US
NAPROXEN NAPROXEN 375MG TABLET, DELAYED RELEASE;ORAL Prescription No AB 091432 INVAGEN PHARMS
NAPROXEN NAPROXEN 375MG TABLET, DELAYED RELEASE;ORAL Prescription No AB 075337 PLIVA
NAPROXEN NAPROXEN 375MG TABLET, DELAYED RELEASE;ORAL Prescription No AB 075227 TEVA

TABLET, DELAYED RELEASE;ORAL; 500MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
EC-NAPROSYN NAPROXEN 500MG TABLET, DELAYED RELEASE;ORAL Prescription Yes AB 020067 ATNAHS PHARMA US
NAPROXEN NAPROXEN 500MG TABLET, DELAYED RELEASE;ORAL Prescription No AB 091432 INVAGEN PHARMS
NAPROXEN NAPROXEN 500MG TABLET, DELAYED RELEASE;ORAL Prescription No AB 075337 PLIVA
NAPROXEN NAPROXEN 500MG TABLET, DELAYED RELEASE;ORAL Prescription No AB 075227 TEVA

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