Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 072573
Company: MYLAN

Products on ANDA 072573

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
PRAZOSIN HYDROCHLORIDE	PRAZOSIN HYDROCHLORIDE	EQ 1MG BASE	CAPSULE; ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 072573

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
02/28/1989	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
06/03/2002	SUPPL-8	Labeling		Label is not available on this site.
08/01/2000	SUPPL-7	Manufacturing (CMC)		Label is not available on this site.
02/25/1998	SUPPL-6	Manufacturing (CMC)		Label is not available on this site.
02/05/1998	SUPPL-5	Manufacturing (CMC)		Label is not available on this site.
10/15/1993	SUPPL-4	Manufacturing (CMC)		Label is not available on this site.
10/04/1990	SUPPL-2	Labeling		Label is not available on this site.
01/31/1990	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.

Therapeutic Equivalents for ANDA 072573

PRAZOSIN 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
PRAZOSIN HYDROCHLORIDE	PRAZOSIN HYDROCHLORIDE	EQ 1MG BASE	CAPSULE; ORAL	Prescription	No	AB	072573	MYLAN