Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 203808
Company: EDENBRIDGE PHARMS

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
08/04/2015 ORIG-1 Approval

Label is not available on this site.

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 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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