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. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
07/25/2022 | SUPPL-4 | Labeling-Package Insert |
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 | 202044 | CHARTWELL RX |
TINIDAZOLE | TINIDAZOLE | 250MG | TABLET;ORAL | Prescription | No | AB | 203808 | EDENBRIDGE PHARMS |
TINIDAZOLE | TINIDAZOLE | 250MG | TABLET;ORAL | Prescription | No | AB | 202489 | THINQ PHARM-CRO PVT |
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 | 202044 | CHARTWELL RX |
TINIDAZOLE | TINIDAZOLE | 500MG | TABLET;ORAL | Prescription | No | AB | 203808 | EDENBRIDGE PHARMS |
TINIDAZOLE | TINIDAZOLE | 500MG | TABLET;ORAL | Prescription | No | AB | 202489 | THINQ PHARM-CRO PVT |