Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 091183
Company: SUN PHARM INDS LTD

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
NAPROXEN SODIUM NAPROXEN SODIUM 220MG 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
05/20/2011 ORIG-1 Approval

Label is not available on this site.

NAPROXEN SODIUM

The products listed here are over-the-counter (OTC) drugs and do not receive therapeutic equivalence ratings. They may not be interchangeable.

TABLET;ORAL; 220MG
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD Application No. Company
ALEVE NAPROXEN SODIUM 220MG TABLET;ORAL Over-the-counter Yes 020204 BAYER
NAPROXEN SODIUM NAPROXEN SODIUM 220MG TABLET;ORAL Over-the-counter No 079096 AMNEAL PHARMS NY
NAPROXEN SODIUM NAPROXEN SODIUM 220MG TABLET;ORAL Over-the-counter No 205497 AUROBINDO PHARMA LTD
NAPROXEN SODIUM NAPROXEN SODIUM 220MG TABLET;ORAL Over-the-counter No 074635 CONTRACT PHARMACAL
NAPROXEN SODIUM NAPROXEN SODIUM 220MG TABLET;ORAL Over-the-counter No 075168 DR REDDYS LABS INC
NAPROXEN SODIUM NAPROXEN SODIUM 220MG TABLET;ORAL Over-the-counter No 091353 GRANULES INDIA
NAPROXEN SODIUM NAPROXEN SODIUM 220MG TABLET;ORAL Over-the-counter No 204872 LNK INTL INC
NAPROXEN SODIUM NAPROXEN SODIUM 220MG TABLET;ORAL Over-the-counter No 090545 MARKSANS PHARMA
NAPROXEN SODIUM NAPROXEN SODIUM 220MG TABLET;ORAL Over-the-counter No 207612 NOVELGENIX THERAPS
NAPROXEN SODIUM NAPROXEN SODIUM 220MG TABLET;ORAL Over-the-counter No 074661 PERRIGO
NAPROXEN SODIUM NAPROXEN SODIUM 220MG TABLET;ORAL Over-the-counter No 091183 SUN PHARM INDS LTD

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