Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 210166
Company: TAKEDA PHARMS USA
Company: TAKEDA PHARMS USA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
MOTEGRITY | PRUCALOPRIDE SUCCINATE | EQ 1MG BASE | TABLET;ORAL | Prescription | AB | Yes | No |
MOTEGRITY | PRUCALOPRIDE SUCCINATE | EQ 2MG BASE | 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 |
---|---|---|---|---|---|---|---|
12/14/2018 | ORIG-1 | Approval | Type 1 - New Molecular Entity | STANDARD |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210166s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/210166Orig1s000Ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/210166Orig1s000TOC.cfm |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
11/09/2020 | SUPPL-2 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/210166s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/210166Orig1s002ltr.pdf |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
11/09/2020 | SUPPL-2 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/210166s002lbl.pdf | |
12/14/2018 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210166s000lbl.pdf |
MOTEGRITY
TABLET;ORAL; EQ 1MG BASE
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
MOTEGRITY | PRUCALOPRIDE SUCCINATE | EQ 1MG BASE | TABLET;ORAL | Prescription | Yes | AB | 210166 | TAKEDA PHARMS USA |
PRUCALOPRIDE SUCCINATE | PRUCALOPRIDE SUCCINATE | EQ 1MG BASE | TABLET;ORAL | Prescription | No | AB | 218492 | NOVITIUM PHARMA |
TABLET;ORAL; EQ 2MG BASE
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
MOTEGRITY | PRUCALOPRIDE SUCCINATE | EQ 2MG BASE | TABLET;ORAL | Prescription | Yes | AB | 210166 | TAKEDA PHARMS USA |
PRUCALOPRIDE SUCCINATE | PRUCALOPRIDE SUCCINATE | EQ 2MG BASE | TABLET;ORAL | Prescription | No | AB | 218492 | NOVITIUM PHARMA |