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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 209102
Company: RUBICON
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
BACLOFEN BACLOFEN 5MG TABLET;ORAL Prescription AB No No
BACLOFEN BACLOFEN 10MG TABLET;ORAL Prescription AB No No
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
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

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 211555 EYWA PHARMA
BACLOFEN BACLOFEN 5MG TABLET;ORAL Prescription No AB 077971 IMPAX
BACLOFEN BACLOFEN 5MG TABLET;ORAL Prescription No AB 212378 INNOGENIX
BACLOFEN BACLOFEN 5MG TABLET;ORAL Prescription No AB 214374 KARTHA
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 209102 RUBICON
BACLOFEN BACLOFEN 5MG TABLET;ORAL Prescription No AB 211659 ZYDUS

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 077971 IMPAX
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 214374 KARTHA
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 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 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

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 214099 AUROBINDO PHARMA LTD
BACLOFEN BACLOFEN 20MG TABLET;ORAL Prescription No AB 214114 BEXIMCO PHARMS USA
BACLOFEN BACLOFEN 20MG TABLET;ORAL Prescription No AB 211555 EYWA PHARMA
BACLOFEN BACLOFEN 20MG TABLET;ORAL Prescription No AB 077971 IMPAX
BACLOFEN BACLOFEN 20MG TABLET;ORAL Prescription No AB 212378 INNOGENIX
BACLOFEN BACLOFEN 20MG TABLET;ORAL Prescription No AB 072235 IVAX SUB TEVA PHARMS
BACLOFEN BACLOFEN 20MG TABLET;ORAL Prescription No AB 214374 KARTHA
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 078401 NORTHSTAR HLTHCARE
BACLOFEN BACLOFEN 20MG TABLET;ORAL Prescription No AB 077088 OXFORD PHARMS
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 077068 VINTAGE PHARMS
BACLOFEN BACLOFEN 20MG TABLET;ORAL Prescription No AB 211659 ZYDUS
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