← FDA DRUG APPROVALS

FDA ANDA · ANDA070098

METHYLDOPA

Sponsor: HERITAGE PHARMA

APPLICATION
ANDA070098
TYPE
ANDA
ORIGINAL APPROVAL
1986-02-20
LATEST ACTION
2011-08-17
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

METHYLDOPADiscontinued
METHYLDOPA 250MG · TABLET · ORAL

Approval history

2011-08-17Labeling · Supplement 58AP
2005-07-26Labeling · Supplement 52AP
2002-07-29Manufacturing (CMC) · Supplement 47AP
2002-03-08Manufacturing (CMC) · Supplement 46AP
2001-09-12Manufacturing (CMC) · Supplement 45AP
2000-07-26Manufacturing (CMC) · Supplement 44AP
2000-07-26Manufacturing (CMC) · Supplement 42AP
2000-07-26Manufacturing (CMC) · Supplement 40AP
2000-07-26Manufacturing (CMC) · Supplement 41AP
2000-03-28Manufacturing (CMC) · Supplement 38AP
2000-03-22Manufacturing (CMC) · Supplement 36AP
2000-03-22Manufacturing (CMC) · Supplement 37AP
2000-03-22Labeling · Supplement 43AP
2000-01-28Manufacturing (CMC) · Supplement 35AP
2000-01-18Labeling · Supplement 39AP
1999-11-23Manufacturing (CMC) · Supplement 34AP
1999-08-20Manufacturing (CMC) · Supplement 33AP
1999-07-20Manufacturing (CMC) · Supplement 31AP
1999-01-28Labeling · Supplement 32AP
1998-12-09Manufacturing (CMC) · Supplement 30AP
1997-05-30Manufacturing (CMC) · Supplement 29AP
1997-01-06Manufacturing (CMC) · Supplement 26AP
1997-01-06Manufacturing (CMC) · Supplement 27AP
1996-12-10Labeling · Supplement 28AP
1996-03-13Manufacturing (CMC) · Supplement 25AP
1993-09-01Labeling · Supplement 24AP
1992-09-18Manufacturing (CMC) · Supplement 22AP
1992-09-18Manufacturing (CMC) · Supplement 23AP
1992-05-18Manufacturing (CMC) · Supplement 21AP
1991-08-12Labeling · Supplement 20AP
1989-03-08Bioequivalence · Supplement 19AP
1988-08-30Manufacturing (CMC) · Supplement 12AP
1988-06-10Labeling · Supplement 13AP
1987-12-29Manufacturing (CMC) · Supplement 5AP
1987-12-29Manufacturing (CMC) · Supplement 4AP
1987-10-20Manufacturing (CMC) · Supplement 11AP
1987-04-07Manufacturing (CMC) · Supplement 3AP
1986-07-10Manufacturing (CMC) · Supplement 1AP
1986-02-20OriginalAP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

Weekly Briefing

Get the Weekly GxP Briefing

Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.

Read a past issue →