Details for New Drug Application (NDA): 204521
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NDA 204521 describes PIMOZIDE, which is a drug marketed by Endo Operations and is included in one NDA. It is available from one supplier. Additional details are available on the PIMOZIDE profile page.
The generic ingredient in PIMOZIDE is pimozide. There are six drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the pimozide profile page.
The generic ingredient in PIMOZIDE is pimozide. There are six drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the pimozide profile page.
Summary for 204521
| Tradename: | PIMOZIDE |
| Applicant: | Endo Operations |
| Ingredient: | pimozide |
| Patents: | 0 |
Suppliers and Packaging for NDA: 204521
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| PIMOZIDE | pimozide | TABLET;ORAL | 204521 | ANDA | Endo USA, Inc. | 49884-347 | 49884-347-01 | 100 TABLET in 1 BOTTLE (49884-347-01) |
| PIMOZIDE | pimozide | TABLET;ORAL | 204521 | ANDA | Endo USA, Inc. | 49884-348 | 49884-348-01 | 100 TABLET in 1 BOTTLE (49884-348-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 1MG | ||||
| Approval Date: | Sep 28, 2015 | TE: | RLD: | No | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 2MG | ||||
| Approval Date: | Sep 28, 2015 | TE: | RLD: | No | |||||
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