Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 078504
Company: NORTHSTAR HLTHCARE

Products on ANDA 078504

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 078504

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/18/2009	ORIG-1	Approval				Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/15/2015	SUPPL-5	Labeling-Package Insert		Label is not available on this site.
04/15/2015	SUPPL-4	Labeling-Package Insert		Label is not available on this site.
12/28/2011	SUPPL-2	Labeling-Package Insert		Label is not available on this site.
03/25/2010	SUPPL-1	Labeling-Container/Carton Labels		Label is not available on this site.

Therapeutic Equivalents for ANDA 078504

BACLOFEN

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	214099	AUROBINDO PHARMA LTD
BACLOFEN	BACLOFEN	10MG	TABLET;ORAL	Prescription	No	AB	214114	BEXIMCO PHARMS USA
BACLOFEN	BACLOFEN	10MG	TABLET;ORAL	Prescription	No	AB	211555	EYWA PHARMA
BACLOFEN	BACLOFEN	10MG	TABLET;ORAL	Prescription	No	AB	217788	GRAVITI PHARMS
BACLOFEN	BACLOFEN	10MG	TABLET;ORAL	Prescription	No	AB	212378	INNOGENIX
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	077068	VINTAGE PHARMS
BACLOFEN	BACLOFEN	10MG	TABLET;ORAL	Prescription	No	AB	211659	ZYDUS LIFESCIENCES