Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 021618
Company: MISSION PHARMA
Company: MISSION PHARMA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
TINDAMAX | TINIDAZOLE | 250MG | TABLET;ORAL | Prescription | AB | Yes | No |
TINDAMAX | TINIDAZOLE | 500MG | TABLET;ORAL | Prescription | AB | Yes | Yes |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
05/17/2004 | ORIG-1 | Approval | Type 1 - New Molecular Entity | STANDARD; Orphan |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21618_tindamax_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21618ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/21-618_21-681_21-682_Tindamax.cfm |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
12/15/2021 | SUPPL-8 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021618s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/021618Orig1s008ltr.pdf | |
10/09/2020 | SUPPL-7 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/21618s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/021618Orig1s007ltr.pdf | |
06/07/2019 | SUPPL-6 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021618s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/021618Orig1s006ltr.pdf | |
04/01/2016 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
05/21/2007 | SUPPL-3 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021618s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021618s003ltr.pdf |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
12/15/2021 | SUPPL-8 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021618s008lbl.pdf | |
10/09/2020 | SUPPL-7 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/21618s007lbl.pdf | |
06/07/2019 | SUPPL-6 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021618s006lbl.pdf | |
05/21/2007 | SUPPL-3 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021618s003lbl.pdf | |
05/17/2004 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21618_tindamax_lbl.pdf |
TINDAMAX
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 |