Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 201050
Company: HIKMA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PHENOXYBENZAMINE HYDROCHLORIDE PHENOXYBENZAMINE HYDROCHLORIDE 10MG CAPSULE;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
07/16/2012 ORIG-1 Approval Not Applicable Letter (PDF)
Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/201050Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/201050Orig1s000.pdf

PHENOXYBENZAMINE HYDROCHLORIDE

CAPSULE;ORAL; 10MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DIBENZYLINE PHENOXYBENZAMINE HYDROCHLORIDE 10MG CAPSULE;ORAL Prescription Yes AB 008708 CONCORDIA
PHENOXYBENZAMINE HYDROCHLORIDE PHENOXYBENZAMINE HYDROCHLORIDE 10MG CAPSULE;ORAL Prescription No AB 201050 HIKMA
PHENOXYBENZAMINE HYDROCHLORIDE PHENOXYBENZAMINE HYDROCHLORIDE 10MG CAPSULE;ORAL Prescription No AB 204522 PAR PHARM INC

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