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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 209592
Company: MYLAN LABS LTD

Products on ANDA 209592

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
BACLOFEN	BACLOFEN	0.5MG/ML	INJECTABLE;INTRATHECAL	Prescription	AP	No	No
BACLOFEN	BACLOFEN	2MG/ML	INJECTABLE;INTRATHECAL	Prescription	AP	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 209592

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/21/2018	ORIG-1	Approval		STANDARD	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/209592Orig1s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/209592Orig1s000ltr.pdf

Labels for ANDA 209592

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/21/2018	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/209592Orig1s000lbl.pdf

Therapeutic Equivalents for ANDA 209592

BACLOFEN

INJECTABLE;INTRATHECAL; 0.5MG/ML
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
BACLOFEN	BACLOFEN	0.5MG/ML	INJECTABLE;INTRATHECAL	Prescription	No	AP	091193	AMNEAL
BACLOFEN	BACLOFEN	0.5MG/ML	INJECTABLE;INTRATHECAL	Prescription	No	AP	210048	MAIA PHARMS INC
BACLOFEN	BACLOFEN	0.5MG/ML	INJECTABLE;INTRATHECAL	Prescription	No	AP	209592	MYLAN LABS LTD
BACLOFEN	BACLOFEN	0.5MG/ML	INJECTABLE;INTRATHECAL	Prescription	No	AP	217324	RUBICON
GABLOFEN	BACLOFEN	0.5MG/ML	INJECTABLE;INTRATHECAL	Prescription	Yes	AP	022462	PIRAMAL CRITICAL
LIORESAL	BACLOFEN	0.5MG/ML	INJECTABLE;INTRATHECAL	Prescription	Yes	AP	020075	AMNEAL

INJECTABLE;INTRATHECAL; 2MG/ML
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
BACLOFEN	BACLOFEN	2MG/ML	INJECTABLE;INTRATHECAL	Prescription	No	AP	091193	AMNEAL
BACLOFEN	BACLOFEN	2MG/ML	INJECTABLE;INTRATHECAL	Prescription	No	AP	210048	MAIA PHARMS INC
BACLOFEN	BACLOFEN	2MG/ML	INJECTABLE;INTRATHECAL	Prescription	No	AP	209592	MYLAN LABS LTD
BACLOFEN	BACLOFEN	2MG/ML	INJECTABLE;INTRATHECAL	Prescription	No	AP	217324	RUBICON
GABLOFEN	BACLOFEN	2MG/ML	INJECTABLE;INTRATHECAL	Prescription	Yes	AP	022462	PIRAMAL CRITICAL
LIORESAL	BACLOFEN	2MG/ML	INJECTABLE;INTRATHECAL	Prescription	Yes	AP	020075	AMNEAL

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