Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 075498
Company: HIKMA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TERAZOSIN HYDROCHLORIDE TERAZOSIN HYDROCHLORIDE EQ 1MG BASE CAPSULE;ORAL Prescription AB No No
TERAZOSIN HYDROCHLORIDE TERAZOSIN HYDROCHLORIDE EQ 2MG BASE CAPSULE;ORAL Prescription AB No No
TERAZOSIN HYDROCHLORIDE TERAZOSIN HYDROCHLORIDE EQ 5MG BASE CAPSULE;ORAL Prescription AB No No
TERAZOSIN HYDROCHLORIDE TERAZOSIN HYDROCHLORIDE EQ 10MG BASE 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
04/12/2001 ORIG-1 Approval Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75498ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
06/07/2006 SUPPL-7 Labeling

Label is not available on this site.

10/01/2002 SUPPL-1 Labeling

Label is not available on this site.

TERAZOSIN HYDROCHLORIDE

CAPSULE;ORAL; EQ 1MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
TERAZOSIN HYDROCHLORIDE TERAZOSIN HYDROCHLORIDE EQ 1MG BASE CAPSULE;ORAL Prescription No AB 074823 APNAR PHARMA LP
TERAZOSIN HYDROCHLORIDE TERAZOSIN HYDROCHLORIDE EQ 1MG BASE CAPSULE;ORAL Prescription No AB 075614 HERITAGE PHARMA
TERAZOSIN HYDROCHLORIDE TERAZOSIN HYDROCHLORIDE EQ 1MG BASE CAPSULE;ORAL Prescription No AB 075498 HIKMA
TERAZOSIN HYDROCHLORIDE TERAZOSIN HYDROCHLORIDE EQ 1MG BASE CAPSULE;ORAL Prescription No AB 075317 JUBILANT CADISTA
TERAZOSIN HYDROCHLORIDE TERAZOSIN HYDROCHLORIDE EQ 1MG BASE CAPSULE;ORAL Prescription No AB 075140 MYLAN

CAPSULE;ORAL; EQ 2MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
TERAZOSIN HYDROCHLORIDE TERAZOSIN HYDROCHLORIDE EQ 2MG BASE CAPSULE;ORAL Prescription No AB 074823 APNAR PHARMA LP
TERAZOSIN HYDROCHLORIDE TERAZOSIN HYDROCHLORIDE EQ 2MG BASE CAPSULE;ORAL Prescription No AB 075614 HERITAGE PHARMA
TERAZOSIN HYDROCHLORIDE TERAZOSIN HYDROCHLORIDE EQ 2MG BASE CAPSULE;ORAL Prescription No AB 075498 HIKMA
TERAZOSIN HYDROCHLORIDE TERAZOSIN HYDROCHLORIDE EQ 2MG BASE CAPSULE;ORAL Prescription No AB 075317 JUBILANT CADISTA
TERAZOSIN HYDROCHLORIDE TERAZOSIN HYDROCHLORIDE EQ 2MG BASE CAPSULE;ORAL Prescription No AB 075140 MYLAN

CAPSULE;ORAL; EQ 5MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
TERAZOSIN HYDROCHLORIDE TERAZOSIN HYDROCHLORIDE EQ 5MG BASE CAPSULE;ORAL Prescription No AB 074823 APNAR PHARMA LP
TERAZOSIN HYDROCHLORIDE TERAZOSIN HYDROCHLORIDE EQ 5MG BASE CAPSULE;ORAL Prescription No AB 075614 HERITAGE PHARMA
TERAZOSIN HYDROCHLORIDE TERAZOSIN HYDROCHLORIDE EQ 5MG BASE CAPSULE;ORAL Prescription No AB 075498 HIKMA
TERAZOSIN HYDROCHLORIDE TERAZOSIN HYDROCHLORIDE EQ 5MG BASE CAPSULE;ORAL Prescription No AB 075317 JUBILANT CADISTA
TERAZOSIN HYDROCHLORIDE TERAZOSIN HYDROCHLORIDE EQ 5MG BASE CAPSULE;ORAL Prescription No AB 075140 MYLAN

CAPSULE;ORAL; EQ 10MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
TERAZOSIN HYDROCHLORIDE TERAZOSIN HYDROCHLORIDE EQ 10MG BASE CAPSULE;ORAL Prescription No AB 074823 APNAR PHARMA LP
TERAZOSIN HYDROCHLORIDE TERAZOSIN HYDROCHLORIDE EQ 10MG BASE CAPSULE;ORAL Prescription No AB 075614 HERITAGE PHARMA
TERAZOSIN HYDROCHLORIDE TERAZOSIN HYDROCHLORIDE EQ 10MG BASE CAPSULE;ORAL Prescription No AB 075498 HIKMA
TERAZOSIN HYDROCHLORIDE TERAZOSIN HYDROCHLORIDE EQ 10MG BASE CAPSULE;ORAL Prescription No AB 075317 JUBILANT CADISTA
TERAZOSIN HYDROCHLORIDE TERAZOSIN HYDROCHLORIDE EQ 10MG BASE CAPSULE;ORAL Prescription No AB 075140 MYLAN

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