Details for New Drug Application (NDA): 218812
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NDA 218812 describes PRUCALOPRIDE SUCCINATE, which is a drug marketed by Ajanta Pharma Ltd, Alembic, Alkem Labs Ltd, Amneal, Annora Pharma, Apotex, Appco, H2-pharma, Hikma, Lupin, Micro Labs, MSN, Novitium Pharma, Somerset Therap, Specgx Llc, Teva Pharms Inc, Torrent, Zenara, and Zydus Lifesciences, and is included in nineteen NDAs. It is available from eighteen suppliers. Additional details are available on the PRUCALOPRIDE SUCCINATE profile page.
The generic ingredient in PRUCALOPRIDE SUCCINATE 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 PRUCALOPRIDE SUCCINATE 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 218812
| Tradename: | PRUCALOPRIDE SUCCINATE |
| Applicant: | Amneal |
| Ingredient: | prucalopride succinate |
| Patents: | 0 |
Pharmacology for NDA: 218812
| Mechanism of Action | Serotonin 4 Receptor Agonists |
Suppliers and Packaging for NDA: 218812
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| PRUCALOPRIDE SUCCINATE | prucalopride succinate | TABLET;ORAL | 218812 | ANDA | Amneal Pharmaceuticals NY LLC | 69238-2698 | 69238-2698-1 | 30 TABLET, FILM COATED in 1 BOTTLE (69238-2698-1) |
| PRUCALOPRIDE SUCCINATE | prucalopride succinate | TABLET;ORAL | 218812 | ANDA | Amneal Pharmaceuticals NY LLC | 69238-2699 | 69238-2699-1 | 30 TABLET, FILM COATED in 1 BOTTLE (69238-2699-1) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 1MG BASE | ||||
| Approval Date: | Jun 24, 2025 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 2MG BASE | ||||
| Approval Date: | Jun 24, 2025 | TE: | AB | RLD: | No | ||||
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