← FDA DRUG APPROVALS

FDA NDA · NDA205410

HEMANGEOL

propranolol hydrochloride

Sponsor: ETON

APPLICATION
NDA205410
TYPE
NDA
ORIGINAL APPROVAL
2014-03-14
LATEST ACTION
2021-06-22
ROUTE
ORAL
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription

Products

HEMANGEOL · ReferencePrescription
PROPRANOLOL HYDROCHLORIDE 4.28MG/ML · SOLUTION · ORAL

Approval history

2021-06-22Labeling · Supplement 6 · standard — Label ↗AP
2020-04-02Labeling · Supplement 5 · standard — Letter ↗AP
2019-12-18Labeling · Supplement 3 · standard — Label ↗AP
2015-05-18Manufacturing (CMC) · Supplement 1 · standardAP
2014-03-14Type 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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