Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 091009
Company: ACTAVIS LABS FL

Products on ANDA 091009

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
GUAIFENESIN	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE;ORAL	Over-the-counter	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 091009

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/03/2015	ORIG-1	Approval				Label is not available on this site.

Other OTC Drugs with the Same Active Ingredient, Strength and Dosage Form/Route

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; 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
GUAIFENESIN	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE;ORAL	Over-the-counter	No	215932	DR REDDYS
GUAIFENESIN	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE;ORAL	Over-the-counter	No	213420	GRANULES
GUAIFENESIN	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE;ORAL	Over-the-counter	No	209215	GUARDIAN DRUG
GUAIFENESIN	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE;ORAL	Over-the-counter	No	217780	MARKSANS PHARMA
GUAIFENESIN	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE;ORAL	Over-the-counter	No	209254	OHM LABS INC
GUAIFENESIN	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE;ORAL	Over-the-counter	No	078912	PERRIGO R AND D
MUCINEX	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE;ORAL	Over-the-counter	Yes	021282	RB HLTH