Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 072235
Company: IVAX SUB TEVA PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
BACLOFEN BACLOFEN 20MG TABLET;ORAL Prescription AB No Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
07/21/1988 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
12/01/2010 SUPPL-30 Labeling-Container/Carton Labels

Label is not available on this site.

04/03/2009 SUPPL-26 Labeling

Label is not available on this site.

07/29/2002 SUPPL-12 Manufacturing (CMC)-Facility

Label is not available on this site.

06/04/2001 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

01/28/2000 SUPPL-7 Manufacturing (CMC)-Facility

Label is not available on this site.

04/19/1999 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

10/26/1998 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

04/06/1995 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

07/12/1995 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

09/05/1996 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

BACLOFEN

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 077971 IMPAX LABS
BACLOFEN BACLOFEN 20MG TABLET;ORAL Prescription No AB 072235 IVAX SUB TEVA PHARMS
BACLOFEN BACLOFEN 20MG TABLET;ORAL Prescription No AB 077241 LANNETT
BACLOFEN BACLOFEN 20MG TABLET;ORAL Prescription No AB 077121 MYLAN
BACLOFEN BACLOFEN 20MG TABLET;ORAL Prescription No AB 090334 MYLAN PHARMS INC
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 077862 SUN PHARM INDS INC
BACLOFEN BACLOFEN 20MG TABLET;ORAL Prescription No AB 074584 USL PHARMA
BACLOFEN BACLOFEN 20MG TABLET;ORAL Prescription No AB 077068 VINTAGE PHARMS

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