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FDA NDA · NDA020951

TAGAMET HB 200

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APPLICATION
NDA020951
TYPE
NDA
ORIGINAL APPROVAL
1999-07-09
LATEST ACTION
2000-07-28
ROUTE
ORAL
DOSAGE FORM
SUSPENSION
MARKETING STATUS
Discontinued

Products

TAGAMET HB 200Discontinued
CIMETIDINE 200MG/20ML · SUSPENSION · ORAL

Approval history

2000-07-28Manufacturing (CMC) · Supplement 3 · standardAP
2000-07-24Manufacturing (CMC) · Supplement 2 · standardAP
2000-03-14Manufacturing (CMC) · Supplement 1 · standardAP
1999-07-09Type 3 - New Dosage Form · Original · standardLabelAP
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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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