Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 203808
Company: EDENBRIDGE PHARMS
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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