← FDA DRUG APPROVALS

FDA NDA · NDA021438

INNOPRAN XL

propranolol hydrochloride

Sponsor: ANI PHARMS

APPLICATION
NDA021438
TYPE
NDA
ORIGINAL APPROVAL
2003-03-12
LATEST ACTION
2023-12-22
ROUTE
ORAL
DOSAGE FORM
CAPSULE, EXTENDED RELEASE
MARKETING STATUS
Prescription

Products

INNOPRAN XL · ReferencePrescription
PROPRANOLOL HYDROCHLORIDE 80MG · CAPSULE, EXTENDED RELEASE · ORAL
INNOPRAN XL · ReferencePrescription
PROPRANOLOL HYDROCHLORIDE 120MG · CAPSULE, EXTENDED RELEASE · ORAL

Approval history

2023-12-22Labeling · Supplement 32 · standard — Letter ↗AP
2021-08-16Labeling · Supplement 25 · standard — Letter ↗AP
2013-11-19Labeling · Supplement 16 · unknown — Label ↗AP
2013-10-24Manufacturing (CMC) · Supplement 17 · standardAP
2010-12-14Labeling · Supplement 13 · unknown — Label ↗AP
2010-12-14Labeling · Supplement 14 · unknown — Letter ↗AP
2009-12-30Labeling · Supplement 12 · standard — Letter ↗AP
2008-01-02Labeling · Supplement 11 · standard — Letter ↗AP
2004-10-22Labeling · Supplement 5 · standard — Letter ↗AP
2003-03-12Type 5 - New Formulation or New Manufacturer · Original · standard — Review ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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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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