Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 209215
Company: GUARDIAN DRUG
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
GUAIFENESIN GUAIFENESIN 600MG TABLET, EXTENDED RELEASE;ORAL Over-the-counter None No No
GUAIFENESIN GUAIFENESIN 1.2GM 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
09/06/2017 ORIG-1 Approval STANDARD Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/209215Orig1s000ltr.pdf

GUAIFENESIN

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
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD Application No. Company
GUAIFENESIN GUAIFENESIN 600MG TABLET, EXTENDED RELEASE;ORAL Over-the-counter No 207342 AMNEAL PHARMS
GUAIFENESIN GUAIFENESIN 600MG TABLET, EXTENDED RELEASE;ORAL Over-the-counter No 210453 AUROBINDO PHARMA LTD
GUAIFENESIN GUAIFENESIN 600MG TABLET, EXTENDED RELEASE;ORAL Over-the-counter No 209215 GUARDIAN DRUG
GUAIFENESIN GUAIFENESIN 600MG TABLET, EXTENDED RELEASE;ORAL Over-the-counter No 078912 PERRIGO R AND D
MUCINEX GUAIFENESIN 600MG TABLET, EXTENDED RELEASE;ORAL Over-the-counter Yes 021282 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
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD Application No. Company
GUAIFENESIN GUAIFENESIN 1.2GM TABLET, EXTENDED RELEASE;ORAL Over-the-counter No 091009 ACTAVIS LABS FL
GUAIFENESIN GUAIFENESIN 1.2GM TABLET, EXTENDED RELEASE;ORAL Over-the-counter No 207342 AMNEAL PHARMS
GUAIFENESIN GUAIFENESIN 1.2GM TABLET, EXTENDED RELEASE;ORAL Over-the-counter No 210453 AUROBINDO PHARMA LTD
GUAIFENESIN GUAIFENESIN 1.2GM TABLET, EXTENDED RELEASE;ORAL Over-the-counter No 209215 GUARDIAN DRUG
MUCINEX GUAIFENESIN 1.2GM TABLET, EXTENDED RELEASE;ORAL Over-the-counter Yes 021282 RB HLTH

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