Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 209594
Company: MYLAN LABS LTD

Products on ANDA 209594

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
BACLOFEN	BACLOFEN	1MG/ML	INJECTABLE;INTRATHECAL	Prescription	AP	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 209594

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/06/2018	ORIG-1	Approval		STANDARD	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/209594Orig1s000ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/22/2020	SUPPL-2	Labeling-Package Insert		Label is not available on this site.
10/22/2020	SUPPL-1	Labeling-Package Insert, Labeling-Container/Carton Labels		Label is not available on this site.

Therapeutic Equivalents for ANDA 209594

BACLOFEN

INJECTABLE;INTRATHECAL; 1MG/ML
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
BACLOFEN	BACLOFEN	1MG/ML	INJECTABLE;INTRATHECAL	Prescription	No	AP	210315	MAIA PHARMS INC
BACLOFEN	BACLOFEN	1MG/ML	INJECTABLE;INTRATHECAL	Prescription	No	AP	209594	MYLAN LABS LTD
BACLOFEN	BACLOFEN	1MG/ML	INJECTABLE;INTRATHECAL	Prescription	No	AP	217324	RUBICON
GABLOFEN	BACLOFEN	1MG/ML	INJECTABLE;INTRATHECAL	Prescription	Yes	AP	022462	PIRAMAL CRITICAL