Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

Abbreviated New Drug Application (ANDA): 201172
Company: HIKMA
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
04/30/2012 ORIG-1 Approval Not Applicable

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

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English