Details for New Drug Application (NDA): 219897
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NDA 219897 describes PIMOZIDE, which is a drug marketed by Novitium Pharma and Ph Health and is included in two NDAs. It is available from two suppliers. Additional details are available on the PIMOZIDE profile page.
The generic ingredient in PIMOZIDE is pimozide. There is one drug master file entry for this compound. Two suppliers are listed for this compound. Additional details are available on the pimozide profile page.
The generic ingredient in PIMOZIDE is pimozide. There is one drug master file entry for this compound. Two suppliers are listed for this compound. Additional details are available on the pimozide profile page.
Summary for 219897
| Tradename: | PIMOZIDE |
| Applicant: | Novitium Pharma |
| Ingredient: | pimozide |
| Patents: | 0 |
Suppliers and Packaging for NDA: 219897
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| PIMOZIDE | pimozide | TABLET;ORAL | 219897 | ANDA | ANI Pharmaceuticals, Inc. | 70954-853 | 70954-853-10 | 100 TABLET in 1 BOTTLE (70954-853-10) |
| PIMOZIDE | pimozide | TABLET;ORAL | 219897 | ANDA | ANI Pharmaceuticals, Inc. | 70954-854 | 70954-854-10 | 100 TABLET in 1 BOTTLE (70954-854-10) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 1MG | ||||
| Approval Date: | Apr 13, 2026 | TE: | AB | RLD: | No | ||||
| Regulatory Exclusivity Expiration: | Oct 18, 2026 | ||||||||
| Regulatory Exclusivity Use: | COMPETITIVE GENERIC THERAPY | ||||||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 2MG | ||||
| Approval Date: | Apr 13, 2026 | TE: | AB | RLD: | No | ||||
| Regulatory Exclusivity Expiration: | Oct 18, 2026 | ||||||||
| Regulatory Exclusivity Use: | COMPETITIVE GENERIC THERAPY | ||||||||
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