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FDA ANDA · ANDA071060
PROPRANOLOL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE
Sponsor: CHARTWELL RX
APPLICATION
ANDA071060
TYPE
ANDA
ORIGINAL APPROVAL
1987-08-26
LATEST ACTION
2020-08-20
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
PROPRANOLOL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDEDiscontinued
HYDROCHLOROTHIAZIDE 25MG, PROPRANOLOL HYDROCHLORIDE 40MG · TABLET · ORAL
Approval history
2020-08-20Labeling · Supplement 16 · standardAP
2020-08-06Labeling · Supplement 15 · standardAP
2001-05-09Manufacturing (CMC) · Supplement 12AP
1998-12-31Manufacturing (CMC) · Supplement 10AP
1998-12-31Manufacturing (CMC) · Supplement 9AP
1998-09-08Labeling · Supplement 11AP
1995-03-27Manufacturing (CMC) · Supplement 8AP
1992-03-26Labeling · Supplement 7AP
1991-11-25Labeling · Supplement 6AP
1989-06-27Labeling · Supplement 5AP
1988-10-13Manufacturing (CMC) · Supplement 4AP
1988-10-13Manufacturing (CMC) · Supplement 2AP
1988-04-19Manufacturing (CMC) · Supplement 1AP
1987-08-26OriginalAP
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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