Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 040463
Company: WEST-WARD PHARMS INT
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ORPHENADRINE CITRATE ORPHENADRINE CITRATE 30MG/ML INJECTABLE;INJECTION Prescription AP 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
03/04/2003 ORIG-1 Approval

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
07/23/2019 SUPPL-10 Labeling-Container/Carton Labels

Label is not available on this site.

08/11/2008 SUPPL-5 Labeling

Label is not available on this site.

ORPHENADRINE CITRATE

INJECTABLE;INJECTION; 30MG/ML
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ORPHENADRINE CITRATE ORPHENADRINE CITRATE 30MG/ML INJECTABLE;INJECTION Prescription No AP 040484 AKORN
ORPHENADRINE CITRATE ORPHENADRINE CITRATE 30MG/ML INJECTABLE;INJECTION Prescription No AP 090585 SAGENT PHARMS
ORPHENADRINE CITRATE ORPHENADRINE CITRATE 30MG/ML INJECTABLE;INJECTION Prescription No AP 084779 WATSON LABS
ORPHENADRINE CITRATE ORPHENADRINE CITRATE 30MG/ML INJECTABLE;INJECTION Prescription No AP 040463 WEST-WARD PHARMS INT

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