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FDA NDA · NDA012715

GANTANOL-DS

Sponsor: ROCHE

APPLICATION
NDA012715
TYPE
NDA
ORIGINAL APPROVAL
1965-08-25
LATEST ACTION
2001-09-17
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

GANTANOL-DSDiscontinued
SULFAMETHOXAZOLE 1GM · TABLET · ORAL
GANTANOLDiscontinued
SULFAMETHOXAZOLE 500MG · TABLET · ORAL

Approval history

2001-09-17Labeling · Supplement 29AP
2001-09-17Labeling · Supplement 27AP
2001-09-17Labeling · Supplement 25AP
1978-05-04Labeling · Supplement 24AP
1978-01-05Labeling · Supplement 20AP
1977-05-04Labeling · Supplement 19AP
1965-08-25Type 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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