Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 214445
Company: RUBICON RESEARCH

Products on ANDA 214445

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
BACLOFEN	BACLOFEN	5MG/5ML	SOLUTION;ORAL	Prescription	None	No	No
BACLOFEN	BACLOFEN	10MG/5ML	SOLUTION;ORAL	Prescription	AA	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 214445

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/06/2024	ORIG-1	Approval		STANDARD	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/214445Orig1s000ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/03/2025	SUPPL-2	Labeling-Container/Carton Labels, Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 214445

BACLOFEN

SOLUTION;ORAL; 10MG/5ML
TE Code = AA

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
BACLOFEN	BACLOFEN	10MG/5ML	SOLUTION;ORAL	Prescription	No	AA	214445	RUBICON RESEARCH
OZOBAX DS	BACLOFEN	10MG/5ML	SOLUTION;ORAL	Prescription	Yes	AA	208193	METACEL PHARMS LLC