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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 208193
Company: METACEL PHARMS LLC

Products on NDA 208193

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 208193

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/18/2019	ORIG-1	Approval	Type 3 - New Dosage Form	STANDARD; Orphan	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208193s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/208193Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/208193Orig1s000TOC.html

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/12/2023	SUPPL-2	Manufacturing (CMC)-Facility	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/208193Orig1s002lbl.pdf

Labels for NDA 208193

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/12/2023	SUPPL-2	Manufacturing (CMC)-Facility	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/208193Orig1s002lbl.pdf
09/18/2019	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208193s000lbl.pdf

Therapeutic Equivalents for NDA 208193

OZOBAX

There are no Therapeutic Equivalents.

OZOBAX DS

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

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