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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 040284
Company: LUPIN
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
06/19/1998 ORIG-1 Approval Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/40284ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
01/28/2014 SUPPL-21 Labeling-Package Insert

Label is not available on this site.

04/27/2009 SUPPL-19 Labeling

Label is not available on this site.

10/08/2002 SUPPL-11 Manufacturing (CMC)-Packaging

Label is not available on this site.

10/08/2002 SUPPL-10 Manufacturing (CMC)-Control

Label is not available on this site.

10/08/2002 SUPPL-9 Manufacturing (CMC)-Manufacturing Process

Label is not available on this site.

10/08/2002 SUPPL-8 Manufacturing (CMC)-Facility

Label is not available on this site.

03/22/2002 SUPPL-7 Manufacturing (CMC)-Packaging

Label is not available on this site.

03/22/2002 SUPPL-6 Manufacturing (CMC)-Facility

Label is not available on this site.

07/24/2002 SUPPL-5 Manufacturing (CMC)-Control

Label is not available on this site.

07/24/2002 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

01/26/1999 SUPPL-1 Manufacturing (CMC)

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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