U.S. flag An official website of the United States government
  1. Home
  2. Drug Databases
  3. Drugs@FDA

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 204522
Company: PAR PHARM INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PHENOXYBENZAMINE HYDROCHLORIDE PHENOXYBENZAMINE HYDROCHLORIDE 10MG CAPSULE;ORAL Prescription AB No Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
01/24/2017 ORIG-1 Approval Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/204522Orig1s000ltr.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 212568 AMNEAL
PHENOXYBENZAMINE HYDROCHLORIDE PHENOXYBENZAMINE HYDROCHLORIDE 10MG CAPSULE;ORAL Prescription No AB 201050 HIKMA
PHENOXYBENZAMINE HYDROCHLORIDE PHENOXYBENZAMINE HYDROCHLORIDE 10MG CAPSULE;ORAL Prescription No AB 215042 NOVITIUM PHARMA
PHENOXYBENZAMINE HYDROCHLORIDE PHENOXYBENZAMINE HYDROCHLORIDE 10MG CAPSULE;ORAL Prescription No AB 204522 PAR PHARM INC
Back to Top