Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 216082
Company: GRANULES

Products on ANDA 216082

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	Discontinued	None	No	No
GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE	GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE	1.2GM;120MG	TABLET, EXTENDED RELEASE;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 216082

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/22/2022	ORIG-1	Approval		STANDARD		Label is not available on this site.