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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021682
Company: MISSION PHARMA

Products on NDA 021682

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
TINDAMAX	TINIDAZOLE	250MG	TABLET; ORAL	Prescription	None	No	No
TINDAMAX	TINIDAZOLE	500MG	TABLET; ORAL	Prescription	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 021682

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/17/2004	ORIG-1	Approval	Type 6 - New Indication (no longer used)	STANDARD; Orphan	Review	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/21-618_21-681_21-682_Tindamax.cfm

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