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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 217252
Company: ANI PHARMS

Products on ANDA 217252

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
BACLOFEN	BACLOFEN	25MG/5ML	SUSPENSION;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 217252

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/08/2023	ORIG-1	Approval		STANDARD	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/217252Orig1s000ltr.pdf

Therapeutic Equivalents for ANDA 217252

BACLOFEN

SUSPENSION;ORAL; 25MG/5ML
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
BACLOFEN	BACLOFEN	25MG/5ML	SUSPENSION;ORAL	Prescription	No	AB	217252	ANI PHARMS
FLEQSUVY	BACLOFEN	25MG/5ML	SUSPENSION;ORAL	Prescription	Yes	AB	215602	AZURITY

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