← FDA DRUG APPROVALS

FDA NDA · NDA018553

INDERAL LA

propranolol hydrochloride

Sponsor: ANI PHARMS

APPLICATION
NDA018553
TYPE
NDA
ORIGINAL APPROVAL
1983-04-19
LATEST ACTION
2023-11-07
ROUTE
ORAL
DOSAGE FORM
CAPSULE, EXTENDED RELEASE
MARKETING STATUS
Prescription

Products

INDERAL LA · ReferencePrescription
PROPRANOLOL HYDROCHLORIDE 60MG · CAPSULE, EXTENDED RELEASE · ORAL
INDERAL LA · ReferencePrescription
PROPRANOLOL HYDROCHLORIDE 80MG · CAPSULE, EXTENDED RELEASE · ORAL
INDERAL LA · ReferencePrescription
PROPRANOLOL HYDROCHLORIDE 120MG · CAPSULE, EXTENDED RELEASE · ORAL
INDERAL LA · ReferencePrescription
PROPRANOLOL HYDROCHLORIDE 160MG · CAPSULE, EXTENDED RELEASE · ORAL

Approval history

2023-11-07Manufacturing (CMC) · Supplement 48 · standard — Label ↗AP
2023-11-07Labeling · Supplement 52 · standard — Label ↗AP
2015-12-21Manufacturing (CMC) · Supplement 39 · standardAP
2015-10-22Manufacturing (CMC) · Supplement 38 · standardAP
2011-03-17Labeling · Supplement 37 · unknown — Letter ↗AP
2007-10-31Labeling · Supplement 36 · standard — Letter ↗AP
2007-02-21Labeling · Supplement 35 · standard — Letter ↗AP
2007-01-03Labeling · Supplement 34 · standard — Letter ↗AP
2004-06-09Labeling · Supplement 30 · standard — Letter ↗AP
2002-02-06Labeling · Supplement 29 · standardAP
2000-03-31Manufacturing (CMC) · Supplement 28 · standardAP
1999-08-22Labeling · Supplement 27 · standardAP
1997-11-07Labeling · Supplement 26 · standardAP
1990-04-17Manufacturing (CMC) · Supplement 25 · standardAP
1990-02-09Manufacturing (CMC) · Supplement 24 · standardAP
1989-07-10Manufacturing (CMC) · Supplement 23 · standardAP
1989-06-05Manufacturing (CMC) · Supplement 22 · standardAP
1989-04-10Manufacturing (CMC) · Supplement 21 · standardAP
1989-01-25Manufacturing (CMC) · Supplement 20 · standardAP
1988-08-08Manufacturing (CMC) · Supplement 19 · standardAP
1988-05-25Manufacturing (CMC) · Supplement 18 · standardAP
1987-03-18Efficacy · Supplement 13 — Review ↗AP
1987-01-20Manufacturing (CMC) · Supplement 17 · standardAP
1986-09-02Manufacturing (CMC) · Supplement 16 · standardAP
1986-05-27Manufacturing (CMC) · Supplement 15 · standard — Review ↗AP
1986-03-04Manufacturing (CMC) · Supplement 12 · standard — Review ↗AP
1986-01-07Manufacturing (CMC) · Supplement 9 · standardAP
1985-11-20Manufacturing (CMC) · Supplement 11 · standardAP
1985-08-20Efficacy · Supplement 8AP
1985-04-02Manufacturing (CMC) · Supplement 10 · standardAP
1985-03-21Labeling · Supplement 6 — Review ↗AP
1984-10-11Manufacturing (CMC) · Supplement 4 · standardAP
1984-08-09Manufacturing (CMC) · Supplement 5 · standard — Review ↗AP
1984-03-06Manufacturing (CMC) · Supplement 2 · standardAP
1984-01-09Efficacy · Supplement 1AP
1983-04-19Type 3 - New Dosage Form · Original · standardAP
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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