APPLICATION
NDA019059
TYPE
NDA
ORIGINAL APPROVAL
1985-07-03
LATEST ACTION
2001-11-01
ROUTE
ORAL
DOSAGE FORM
CAPSULE, EXTENDED RELEASE
MARKETING STATUS
Discontinued
Products
INDERIDE LA 160/50Discontinued
HYDROCHLOROTHIAZIDE 50MG, PROPRANOLOL HYDROCHLORIDE 160MG · CAPSULE, EXTENDED RELEASE · ORAL
INDERIDE LA 80/50Discontinued
HYDROCHLOROTHIAZIDE 50MG, PROPRANOLOL HYDROCHLORIDE 80MG · CAPSULE, EXTENDED RELEASE · ORAL
INDERIDE LA 120/50Discontinued
HYDROCHLOROTHIAZIDE 50MG, PROPRANOLOL HYDROCHLORIDE 120MG · CAPSULE, EXTENDED RELEASE · ORAL
Approval history
2001-11-01Labeling · Supplement 16 · standardAP
2001-05-03Labeling · Supplement 17 · standardAP
1998-05-08Labeling · Supplement 15 · standardAP
1990-05-14Manufacturing (CMC) · Supplement 14 · standardAP
1989-04-12Manufacturing (CMC) · Supplement 13 · standardAP
1989-04-10Manufacturing (CMC) · Supplement 12 · standardAP
1989-01-25Manufacturing (CMC) · Supplement 11 · standardAP
1988-05-25Manufacturing (CMC) · Supplement 10 · standardAP
1987-01-20Manufacturing (CMC) · Supplement 7 · standardAP
1987-01-06Manufacturing (CMC) · Supplement 9 · standardAP
1986-11-12Manufacturing (CMC) · Supplement 8 · standardAP
1986-07-24Manufacturing (CMC) · Supplement 2 · standardAP
1986-07-02Manufacturing (CMC) · Supplement 5 · standardAP
1986-03-20Manufacturing (CMC) · Supplement 4 · standardAP
1986-03-20Manufacturing (CMC) · Supplement 3 · standardAP
1985-10-22Manufacturing (CMC) · Supplement 1 · standardAP
1985-07-03Type 3 - New Dosage Form · Original · standardAP
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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