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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 040249
Company: ANDA REPOSITORY
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
01/29/1999 ORIG-1 Approval Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/anda/99/40249_Orphenadrine%20Citrate_Prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/40249ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/99/040249_orphenadrine_toc.cfm
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
01/29/1999 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/anda/99/40249_Orphenadrine%20Citrate_Prntlbl.pdf

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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