Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 202489
Company: UNIQUE PHARM LABS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TINIDAZOLE TINIDAZOLE 250MG TABLET;ORAL Prescription AB No No
TINIDAZOLE TINIDAZOLE 500MG TABLET;ORAL Prescription AB No No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
10/09/2013 ORIG-1 Approval

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
10/09/2013 SUPPL-1 Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202489Orig1s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/202489Orig1s000ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
10/09/2013 SUPPL-1 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202489Orig1s000lbl.pdf

TINIDAZOLE

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 202044 NOVEL LABS INC
TINIDAZOLE TINIDAZOLE 250MG TABLET;ORAL Prescription No AB 202489 UNIQUE PHARM LABS
TINIDAZOLE TINIDAZOLE 250MG TABLET;ORAL Prescription No AB 201172 WEST-WARD PHARMS INT

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 202044 NOVEL LABS INC
TINIDAZOLE TINIDAZOLE 500MG TABLET;ORAL Prescription No AB 202489 UNIQUE PHARM LABS
TINIDAZOLE TINIDAZOLE 500MG TABLET;ORAL Prescription No AB 201172 WEST-WARD PHARMS INT

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