Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 021618
Company: MISSION PHARMA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TINDAMAX TINIDAZOLE 250MG TABLET;ORAL Prescription AB Yes No
TINDAMAX TINIDAZOLE 500MG TABLET;ORAL Prescription AB Yes Yes
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 1 - New Molecular Entity STANDARD; Orphan Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21618_tindamax_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21618ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/21-618_21-681_21-682_Tindamax.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
06/07/2019 SUPPL-6 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021618s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/021618Orig1s006ltr.pdf
04/01/2016 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

05/21/2007 SUPPL-3 Efficacy-New Indication Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021618s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021618s003ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
06/07/2019 SUPPL-6 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021618s006lbl.pdf
05/21/2007 SUPPL-3 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021618s003lbl.pdf
05/17/2004 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21618_tindamax_lbl.pdf

TINDAMAX

TABLET;ORAL; 250MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
TINDAMAX TINIDAZOLE 250MG TABLET;ORAL Prescription Yes AB 021618 MISSION PHARMA
TINIDAZOLE TINIDAZOLE 250MG TABLET;ORAL Prescription No AB 203808 EDENBRIDGE PHARMS
TINIDAZOLE TINIDAZOLE 250MG TABLET;ORAL Prescription No AB 201172 HIKMA
TINIDAZOLE TINIDAZOLE 250MG TABLET;ORAL Prescription No AB 202044 NOVEL LABS INC
TINIDAZOLE TINIDAZOLE 250MG TABLET;ORAL Prescription No AB 202489 UNIQUE PHARM LABS

TABLET;ORAL; 500MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
TINDAMAX TINIDAZOLE 500MG TABLET;ORAL Prescription Yes AB 021618 MISSION PHARMA
TINIDAZOLE TINIDAZOLE 500MG TABLET;ORAL Prescription No AB 203808 EDENBRIDGE PHARMS
TINIDAZOLE TINIDAZOLE 500MG TABLET;ORAL Prescription No AB 201172 HIKMA
TINIDAZOLE TINIDAZOLE 500MG TABLET;ORAL Prescription No AB 202044 NOVEL LABS INC
TINIDAZOLE TINIDAZOLE 500MG TABLET;ORAL Prescription No AB 202489 UNIQUE PHARM LABS

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