Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 202489
Company: THINQ PHARM-CRO PVT
Company: THINQ PHARM-CRO PVT
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 |
---|---|---|---|---|---|
09/12/2023 | SUPPL-6 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
||
05/26/2020 | SUPPL-3 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
||
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 | 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 |