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FDA ANDA · ANDA070614

METHYLDOPA AND HYDROCHLOROTHIAZIDE

Sponsor: STRIDES PHARMA INTL

APPLICATION
ANDA070614
TYPE
ANDA
ORIGINAL APPROVAL
1987-02-02
LATEST ACTION
2020-08-20
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

METHYLDOPA AND HYDROCHLOROTHIAZIDEDiscontinued
HYDROCHLOROTHIAZIDE 30MG, METHYLDOPA 500MG · TABLET · ORAL
METHYLDOPA AND HYDROCHLOROTHIAZIDEDiscontinued
HYDROCHLOROTHIAZIDE 15MG, METHYLDOPA 250MG · TABLET · ORAL
METHYLDOPA AND HYDROCHLOROTHIAZIDEDiscontinued
HYDROCHLOROTHIAZIDE 25MG, METHYLDOPA 250MG · TABLET · ORAL
METHYLDOPA AND HYDROCHLOROTHIAZIDEDiscontinued
HYDROCHLOROTHIAZIDE 50MG, METHYLDOPA 500MG · TABLET · ORAL

Approval history

2020-08-20Labeling · Supplement 27 · standardAP
1998-01-21Manufacturing (CMC) · Supplement 26AP
1997-07-30Manufacturing (CMC) · Supplement 18AP
1997-07-30Manufacturing (CMC) · Supplement 16AP
1997-07-30Manufacturing (CMC) · Supplement 17AP
1997-07-30Manufacturing (CMC) · Supplement 15AP
1996-06-06Labeling · Supplement 25AP
1994-01-27Labeling · Supplement 24AP
1993-12-22Manufacturing (CMC) · Supplement 19AP
1993-07-02Labeling · Supplement 23AP
1992-07-29Labeling · Supplement 22AP
1992-06-09Labeling · Supplement 21AP
1989-01-17Labeling · Supplement 14AP
1988-08-18Labeling · Supplement 13AP
1988-03-24Manufacturing (CMC) · Supplement 9AP
1988-02-04Manufacturing (CMC) · Supplement 10AP
1988-01-22Labeling · Supplement 12AP
1987-10-14Manufacturing (CMC) · Supplement 7AP
1987-10-13Manufacturing (CMC) · Supplement 8AP
1987-10-13Manufacturing (CMC) · Supplement 6AP
1987-09-29Labeling · Supplement 3AP
1987-09-29Manufacturing (CMC) · Supplement 4AP
1987-09-29Manufacturing (CMC) · Supplement 5AP
1987-08-06Manufacturing (CMC) · Supplement 2AP
1987-05-28Manufacturing (CMC) · Supplement 1AP
1987-02-02OriginalAP
VIEW ON DRUGS@FDA ↗

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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.

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