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FDA NDA · NDA020453

PANDEL

Sponsor: ANI PHARMS

APPLICATION
NDA020453
TYPE
NDA
ORIGINAL APPROVAL
1997-02-28
LATEST ACTION
2017-01-25
ROUTE
TOPICAL
DOSAGE FORM
CREAM
MARKETING STATUS
Discontinued

Products

PANDEL · ReferenceDiscontinued
HYDROCORTISONE PROBUTATE 0.1% · CREAM · TOPICAL

Approval history

2017-01-25Efficacy · Supplement 7 · standard — Label ↗AP
2015-10-20Manufacturing (CMC) · Supplement 5 · standardAP
1997-02-28Type 2 - New Active Ingredient · Original · standardAP
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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