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FDA NDA · NDA019806

SEMPREX-D

Sponsor: ENDO OPERATIONS

APPLICATION
NDA019806
TYPE
NDA
ORIGINAL APPROVAL
1994-03-25
LATEST ACTION
2018-04-11
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Discontinued

Products

SEMPREX-D · ReferenceDiscontinued
ACRIVASTINE 8MG, PSEUDOEPHEDRINE HYDROCHLORIDE 60MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · CAPSULE · ORAL

Approval history

2018-04-11Labeling · Supplement 13 · standard — Label ↗AP
2004-02-25Labeling · Supplement 8 · standard — Letter ↗AP
2002-02-20Manufacturing (CMC) · Supplement 5 · standardAP
2000-01-21Manufacturing (CMC) · Supplement 4 · standardAP
1997-12-04Manufacturing (CMC) · Supplement 3 · standardAP
1996-07-30Manufacturing (CMC) · Supplement 2 · standardAP
1994-09-23Labeling · Supplement 1 · standardAP
1994-03-25Type 1 - New Molecular Entity and Type 4 - New Combination · 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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