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FDA NDA · NDA008848

PAMINE FORTE

Sponsor: FOUGERA

APPLICATION
NDA008848
TYPE
NDA
ORIGINAL APPROVAL
1953-04-09
LATEST ACTION
2005-05-16
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

PAMINE FORTEDiscontinued
METHSCOPOLAMINE BROMIDE 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
PAMINEDiscontinued
METHSCOPOLAMINE BROMIDE 2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL

Approval history

2005-05-16Manufacturing (CMC) · Supplement 25 · standard — Letter ↗AP
2003-03-25Manufacturing (CMC) · Supplement 24 · standard — Letter ↗AP
2001-06-22Manufacturing (CMC) · Supplement 23 · standardAP
1999-11-08Manufacturing (CMC) · Supplement 22 · standardAP
1999-11-08Manufacturing (CMC) · Supplement 21 · standardAP
1997-10-24Manufacturing (CMC) · Supplement 20 · standardAP
1989-08-02Labeling · Supplement 17AP
1986-09-04Labeling · Supplement 18 — Review ↗AP
1980-11-28Supplement · Supplement 16 · standardAP
1980-11-28Manufacturing (CMC) · Supplement 14 · standardAP
1980-11-28Labeling · Supplement 15AP
1953-04-09Type 1 - New Molecular Entity · Original · standardAP
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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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