Details for New Drug Application (NDA): 210166
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NDA 210166 describes MOTEGRITY, which is a drug marketed by Takeda Pharms Usa and is included in one NDA. It is available from one supplier. Additional details are available on the MOTEGRITY profile page.
The generic ingredient in MOTEGRITY is prucalopride succinate. There is one drug master file entry for this compound. Nineteen suppliers are listed for this compound. Additional details are available on the prucalopride succinate profile page.
The generic ingredient in MOTEGRITY is prucalopride succinate. There is one drug master file entry for this compound. Nineteen suppliers are listed for this compound. Additional details are available on the prucalopride succinate profile page.
Summary for 210166
| Tradename: | MOTEGRITY |
| Applicant: | Takeda Pharms Usa |
| Ingredient: | prucalopride succinate |
| Patents: | 0 |
Pharmacology for NDA: 210166
| Mechanism of Action | Serotonin 4 Receptor Agonists |
Suppliers and Packaging for NDA: 210166
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| MOTEGRITY | prucalopride succinate | TABLET;ORAL | 210166 | NDA | Takeda Pharmaceuticals America, Inc. | 54092-546 | 54092-546-01 | 30 TABLET, FILM COATED in 1 BOTTLE (54092-546-01) |
| MOTEGRITY | prucalopride succinate | TABLET;ORAL | 210166 | NDA | Takeda Pharmaceuticals America, Inc. | 54092-547 | 54092-547-01 | 30 TABLET, FILM COATED in 1 BOTTLE (54092-547-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 1MG BASE | ||||
| Approval Date: | Dec 14, 2018 | TE: | AB | RLD: | Yes | ||||
| Regulatory Exclusivity Expiration: | Jul 10, 2028 | ||||||||
| Regulatory Exclusivity Use: | ADDITIONAL CLINICAL TRIAL INFORMATION ADDED TO PEDIATRIC USE SUBSECTION | ||||||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 2MG BASE | ||||
| Approval Date: | Dec 14, 2018 | TE: | AB | RLD: | Yes | ||||
| Regulatory Exclusivity Expiration: | Jul 10, 2028 | ||||||||
| Regulatory Exclusivity Use: | ADDITIONAL CLINICAL TRIAL INFORMATION ADDED TO PEDIATRIC USE SUBSECTION | ||||||||
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