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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 091158
Company: BAYSHORE PHARMS LLC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ORPHENADRINE CITRATE ORPHENADRINE CITRATE 100MG TABLET, EXTENDED RELEASE;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
07/27/2012 ORIG-1 Approval

Label is not available on this site.

ORPHENADRINE CITRATE

TABLET, EXTENDED RELEASE;ORAL; 100MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ORPHENADRINE CITRATE ORPHENADRINE CITRATE 100MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 040249 ANDA REPOSITORY
ORPHENADRINE CITRATE ORPHENADRINE CITRATE 100MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 091158 BAYSHORE PHARMS LLC
ORPHENADRINE CITRATE ORPHENADRINE CITRATE 100MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 040284 LUPIN
ORPHENADRINE CITRATE ORPHENADRINE CITRATE 100MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 040327 SANDOZ
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