Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 077381
Company: DR REDDYS LABS INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE NAPROXEN SODIUM; PSEUDOEPHEDRINE HYDROCHLORIDE 220MG;120MG TABLET, EXTENDED RELEASE;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
09/27/2006 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
05/04/2015 SUPPL-6 Labeling-Container/Carton Labels

Label is not available on this site.

05/24/2011 SUPPL-3 Labeling

Label is not available on this site.

NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE

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

TABLET, EXTENDED RELEASE;ORAL; 220MG;120MG
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD Application No. Company
ALEVE-D SINUS & COLD NAPROXEN SODIUM; PSEUDOEPHEDRINE HYDROCHLORIDE 220MG;120MG TABLET, EXTENDED RELEASE;ORAL Over-the-counter Yes 021076 BAYER
NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE NAPROXEN SODIUM; PSEUDOEPHEDRINE HYDROCHLORIDE 220MG;120MG TABLET, EXTENDED RELEASE;ORAL Over-the-counter No 077381 DR REDDYS LABS INC
NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE NAPROXEN SODIUM; PSEUDOEPHEDRINE HYDROCHLORIDE 220MG;120MG TABLET, EXTENDED RELEASE;ORAL Over-the-counter No 076518 PERRIGO

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