Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 075227
Company: TEVA
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
06/30/1998 ORIG-1 Approval Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/75227ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
11/06/2019 SUPPL-20 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

11/06/2019 SUPPL-18 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

11/06/2019 SUPPL-17 Labeling-Package Insert

Label is not available on this site.

09/02/2015 SUPPL-12 Labeling-Package Insert

Label is not available on this site.

04/25/2008 SUPPL-9 Labeling

Label is not available on this site.

05/19/2006 SUPPL-8 Labeling

Label is not available on this site.

02/17/2006 SUPPL-7 Labeling

Label is not available on this site.

12/02/1999 SUPPL-3 Manufacturing (CMC)-Facility

Label is not available on this site.

12/02/1999 SUPPL-2 Manufacturing (CMC)-Facility

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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