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FDA NDA · NDA021076

ALEVE-D SINUS & COLD

Sponsor: BAYER

APPLICATION
NDA021076
TYPE
NDA
ORIGINAL APPROVAL
1999-11-29
LATEST ACTION
2023-07-11
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Discontinued

Products

ALEVE-D SINUS & COLD · ReferenceDiscontinued
NAPROXEN SODIUM 220MG, PSEUDOEPHEDRINE HYDROCHLORIDE 120MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET, EXTENDED RELEASE · ORAL

Approval history

2023-07-11Labeling · Supplement 19 · standard — Letter ↗AP
2022-03-02Labeling · Supplement 17 · standard — Letter ↗AP
2020-04-06Labeling · Supplement 16 · standard — Label ↗AP
2017-09-12Labeling · Supplement 15 · standard — Letter ↗AP
2009-04-17Labeling · Supplement 14 · standard — Letter ↗AP
2008-08-04Labeling · Supplement 13 · standard — Letter ↗AP
2006-01-06Labeling · Supplement 11 · standard — Letter ↗AP
2002-07-31Labeling · Supplement 7 · standard — Letter ↗AP
2001-12-21Manufacturing (CMC) · Supplement 5 · standardAP
2001-10-18Manufacturing (CMC) · Supplement 4 · standardAP
2001-02-15Manufacturing (CMC) · Supplement 3 · standardAP
2000-05-15Labeling · Supplement 1 · standardAP
2000-04-26Manufacturing (CMC) · Supplement 2 · standardAP
1999-11-29Type 4 - New Combination · Original · standard — Letter ↗AP
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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