Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 208369
Company: DR REDDYS LABS LTD
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE 600MG;60MG TABLET, EXTENDED RELEASE;ORAL Over-the-counter None No No
GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE 1.2GM;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
12/29/2017 ORIG-1 Approval STANDARD

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
04/23/2018 SUPPL-1 Labeling-Package Insert

Label is not available on this site.

GUAIFENESIN 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; 600MG;60MG
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD Application No. Company
GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE 600MG;60MG TABLET, EXTENDED RELEASE;ORAL Over-the-counter No 091071 ACTAVIS LABS FL
GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE 600MG;60MG TABLET, EXTENDED RELEASE;ORAL Over-the-counter No 208369 DR REDDYS LABS LTD
MUCINEX D GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE 600MG;60MG TABLET, EXTENDED RELEASE;ORAL Over-the-counter Yes 021585 RB HLTH

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; 1.2GM;120MG
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD Application No. Company
GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE 1.2GM;120MG TABLET, EXTENDED RELEASE;ORAL Over-the-counter No 091071 ACTAVIS LABS FL
GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE 1.2GM;120MG TABLET, EXTENDED RELEASE;ORAL Over-the-counter No 208369 DR REDDYS LABS LTD
MUCINEX D GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE 1.2GM;120MG TABLET, EXTENDED RELEASE;ORAL Over-the-counter Yes 021585 RB HLTH

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