Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 074823
Company: APNAR PHARMA LP
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 Yes
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
03/30/1998 ORIG-1 Approval Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/anda/98/74823ap.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
08/09/2007 SUPPL-15 Labeling

Label is not available on this site.

10/01/2002 SUPPL-11 Labeling

Label is not available on this site.

03/05/2002 SUPPL-9 Manufacturing (CMC)-Control

Label is not available on this site.

04/19/2002 SUPPL-8 Manufacturing (CMC)-Control

Label is not available on this site.

11/06/2001 SUPPL-7 Manufacturing (CMC)-Control

Label is not available on this site.

06/07/2001 SUPPL-6 Manufacturing (CMC)-Control

Label is not available on this site.

06/28/2000 SUPPL-5 Manufacturing (CMC)-Control

Label is not available on this site.

06/18/1999 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

09/07/1999 SUPPL-3 Labeling

Label is not available on this site.

09/07/1999 SUPPL-2 Manufacturing (CMC)-Packaging

Label is not available on this site.

06/18/1999 SUPPL-1 Manufacturing (CMC)

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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