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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 209102
Company: RUBICON

Products on ANDA 209102

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
BACLOFEN	BACLOFEN	5MG	TABLET;ORAL	Prescription	AB	No	Yes
BACLOFEN	BACLOFEN	10MG	TABLET;ORAL	Prescription	AB	No	No
BACLOFEN	BACLOFEN	20MG	TABLET;ORAL	Prescription	AB	No	No
BACLOFEN	BACLOFEN	15MG	TABLET;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 209102

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/28/2017	ORIG-1	Approval		STANDARD	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/209102Orig1s000ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/05/2024	SUPPL-15	Labeling-Package Insert, Labeling-Container/Carton Labels		Label is not available on this site.
09/12/2023	SUPPL-8	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 209102

BACLOFEN

TABLET;ORAL; 5MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
BACLOFEN	BACLOFEN	5MG	TABLET;ORAL	Prescription	No	AB	212378	ANDAS 5 HOLDING
BACLOFEN	BACLOFEN	5MG	TABLET;ORAL	Prescription	No	AB	214114	BEXIMCO PHARMS USA
BACLOFEN	BACLOFEN	5MG	TABLET;ORAL	Prescription	No	AB	217788	GRAVITI PHARMS
BACLOFEN	BACLOFEN	5MG	TABLET;ORAL	Prescription	No	AB	077241	LANNETT CO INC
BACLOFEN	BACLOFEN	5MG	TABLET;ORAL	Prescription	No	AB	215885	MANKIND PHARMA
BACLOFEN	BACLOFEN	5MG	TABLET;ORAL	Prescription	No	AB	217687	MICRO LABS
BACLOFEN	BACLOFEN	5MG	TABLET;ORAL	Prescription	No	AB	214374	RISING
BACLOFEN	BACLOFEN	5MG	TABLET;ORAL	Prescription	No	AB	209102	RUBICON
BACLOFEN	BACLOFEN	5MG	TABLET;ORAL	Prescription	No	AB	212067	UNICHEM
BACLOFEN	BACLOFEN	5MG	TABLET;ORAL	Prescription	No	AB	211659	ZYDUS LIFESCIENCES

TABLET;ORAL; 10MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
BACLOFEN	BACLOFEN	10MG	TABLET;ORAL	Prescription	No	AB	212378	ANDAS 5 HOLDING
BACLOFEN	BACLOFEN	10MG	TABLET;ORAL	Prescription	No	AB	214099	AUROBINDO PHARMA LTD
BACLOFEN	BACLOFEN	10MG	TABLET;ORAL	Prescription	No	AB	214114	BEXIMCO PHARMS USA
BACLOFEN	BACLOFEN	10MG	TABLET;ORAL	Prescription	No	AB	077068	ENDO OPERATIONS
BACLOFEN	BACLOFEN	10MG	TABLET;ORAL	Prescription	No	AB	217788	GRAVITI PHARMS
BACLOFEN	BACLOFEN	10MG	TABLET;ORAL	Prescription	No	AB	072234	IVAX SUB TEVA PHARMS
BACLOFEN	BACLOFEN	10MG	TABLET;ORAL	Prescription	No	AB	077241	LANNETT CO INC
BACLOFEN	BACLOFEN	10MG	TABLET;ORAL	Prescription	No	AB	215885	MANKIND PHARMA
BACLOFEN	BACLOFEN	10MG	TABLET;ORAL	Prescription	No	AB	217687	MICRO LABS
BACLOFEN	BACLOFEN	10MG	TABLET;ORAL	Prescription	No	AB	078401	NORTHSTAR HLTHCARE
BACLOFEN	BACLOFEN	10MG	TABLET;ORAL	Prescription	No	AB	078504	NORTHSTAR HLTHCARE
BACLOFEN	BACLOFEN	10MG	TABLET;ORAL	Prescription	No	AB	077088	OXFORD PHARMS
BACLOFEN	BACLOFEN	10MG	TABLET;ORAL	Prescription	No	AB	214374	RISING
BACLOFEN	BACLOFEN	10MG	TABLET;ORAL	Prescription	No	AB	209102	RUBICON
BACLOFEN	BACLOFEN	10MG	TABLET;ORAL	Prescription	No	AB	212067	UNICHEM
BACLOFEN	BACLOFEN	10MG	TABLET;ORAL	Prescription	No	AB	074584	UPSHER SMITH LABS
BACLOFEN	BACLOFEN	10MG	TABLET;ORAL	Prescription	No	AB	211659	ZYDUS LIFESCIENCES

TABLET;ORAL; 20MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
BACLOFEN	BACLOFEN	20MG	TABLET;ORAL	Prescription	No	AB	212378	ANDAS 5 HOLDING
BACLOFEN	BACLOFEN	20MG	TABLET;ORAL	Prescription	No	AB	214099	AUROBINDO PHARMA LTD
BACLOFEN	BACLOFEN	20MG	TABLET;ORAL	Prescription	No	AB	214114	BEXIMCO PHARMS USA
BACLOFEN	BACLOFEN	20MG	TABLET;ORAL	Prescription	No	AB	077068	ENDO OPERATIONS
BACLOFEN	BACLOFEN	20MG	TABLET;ORAL	Prescription	No	AB	217788	GRAVITI PHARMS
BACLOFEN	BACLOFEN	20MG	TABLET;ORAL	Prescription	No	AB	072235	IVAX SUB TEVA PHARMS
BACLOFEN	BACLOFEN	20MG	TABLET;ORAL	Prescription	No	AB	077241	LANNETT CO INC
BACLOFEN	BACLOFEN	20MG	TABLET;ORAL	Prescription	No	AB	215885	MANKIND PHARMA
BACLOFEN	BACLOFEN	20MG	TABLET;ORAL	Prescription	No	AB	217687	MICRO LABS
BACLOFEN	BACLOFEN	20MG	TABLET;ORAL	Prescription	No	AB	078401	NORTHSTAR HLTHCARE
BACLOFEN	BACLOFEN	20MG	TABLET;ORAL	Prescription	No	AB	077088	OXFORD PHARMS
BACLOFEN	BACLOFEN	20MG	TABLET;ORAL	Prescription	No	AB	214374	RISING
BACLOFEN	BACLOFEN	20MG	TABLET;ORAL	Prescription	No	AB	209102	RUBICON
BACLOFEN	BACLOFEN	20MG	TABLET;ORAL	Prescription	No	AB	212067	UNICHEM
BACLOFEN	BACLOFEN	20MG	TABLET;ORAL	Prescription	No	AB	074584	UPSHER SMITH LABS
BACLOFEN	BACLOFEN	20MG	TABLET;ORAL	Prescription	No	AB	211659	ZYDUS LIFESCIENCES

TABLET;ORAL; 15MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
BACLOFEN	BACLOFEN	15MG	TABLET;ORAL	Prescription	No	AB	209102	RUBICON
BACLOFEN	BACLOFEN	15MG	TABLET;ORAL	Prescription	No	AB	211659	ZYDUS LIFESCIENCES

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