Details for New Drug Application (NDA): 218492
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NDA 218492 describes PRUCALOPRIDE SUCCINATE, which is a drug marketed by Alkem Labs Ltd, Amneal, Annora Pharma, Apotex, Appco, H2-pharma, Hikma, Lupin Ltd, MSN, Novitium Pharma, Somerset Therap, Specgx Llc, Torrent, Zenara, and Zydus Lifesciences, and is included in fifteen NDAs. It is available from thirteen suppliers. Additional details are available on the PRUCALOPRIDE SUCCINATE profile page.
The generic ingredient in PRUCALOPRIDE SUCCINATE is prucalopride succinate. Fourteen 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. Fourteen suppliers are listed for this compound. Additional details are available on the prucalopride succinate profile page.
Summary for 218492
| Tradename: | PRUCALOPRIDE SUCCINATE |
| Applicant: | Novitium Pharma |
| Ingredient: | prucalopride succinate |
| Patents: | 0 |
Pharmacology for NDA: 218492
| Mechanism of Action | Serotonin 4 Receptor Agonists |
Suppliers and Packaging for NDA: 218492
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| PRUCALOPRIDE SUCCINATE | prucalopride succinate | TABLET;ORAL | 218492 | ANDA | ANI Pharmaceuticals, Inc. | 70954-596 | 70954-596-10 | 30 TABLET in 1 BOTTLE (70954-596-10) |
| PRUCALOPRIDE SUCCINATE | prucalopride succinate | TABLET;ORAL | 218492 | ANDA | ANI Pharmaceuticals, Inc. | 70954-597 | 70954-597-10 | 30 TABLET in 1 BOTTLE (70954-597-10) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 1MG BASE | ||||
| Approval Date: | Dec 26, 2024 | TE: | AB | RLD: | No | ||||
| Regulatory Exclusivity Expiration: | Jun 24, 2025 | ||||||||
| Regulatory Exclusivity Use: | COMPETITIVE GENERIC THERAPY | ||||||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 2MG BASE | ||||
| Approval Date: | Dec 26, 2024 | TE: | AB | RLD: | No | ||||
| Regulatory Exclusivity Expiration: | Jun 24, 2025 | ||||||||
| Regulatory Exclusivity Use: | COMPETITIVE GENERIC THERAPY | ||||||||
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