← FDA DRUG APPROVALS

FDA NDA · NDA021618

TINDAMAX

tinidazole

Sponsor: MISSION PHARMA

APPLICATION
NDA021618
TYPE
NDA
ORIGINAL APPROVAL
2004-05-17
LATEST ACTION
2021-12-15
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

TINDAMAX · ReferencePrescription
TINIDAZOLE 250MG · TABLET · ORAL
TINDAMAX · ReferencePrescription
TINIDAZOLE 500MG · TABLET · ORAL

Approval history

2021-12-15Labeling · Supplement 8 · standard — Label ↗AP
2020-10-09Labeling · Supplement 7 · standard — Letter ↗AP
2019-06-07Labeling · Supplement 6 · standard — Letter ↗AP
2016-04-01Manufacturing (CMC) · Supplement 5 · standardAP
2007-05-21Efficacy · Supplement 3 · unknown — Label ↗AP
2004-05-17Type 1 - New Molecular Entity · Original · standard — Review ↗AP
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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