Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 077862
Company: SUN PHARM INDS INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
BACLOFEN BACLOFEN 20MG TABLET;ORAL Prescription AB No No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
08/14/2006 ORIG-1 Approval

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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