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Application 017473
- Type
- NDA
- Sponsor
- TEVA
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | ORAP | PIMOZIDE | TABLET;ORAL | 2MG | Yes | No |
| 003 | ORAP | PIMOZIDE | TABLET;ORAL | 1MG | Yes | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 57844-151 | ORAP | Pimozide | Teva Select Brands | NDA | Current |
| 57844-198 | ORAP | Pimozide | Teva Select Brands | NDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 40744 | SUPPL | 2012-01-27 |
| 13152 | SUPPL | 2011-10-03 |
| 11000 | SUPPL | 2011-09-30 |
| 13151 | SUPPL | 2010-12-06 |
| 10999 | SUPPL | 2010-12-04 |
| 13150 | SUPPL | 2009-07-23 |
| 33280 | SUPPL | 2009-07-21 |
| 33279 | SUPPL | 2009-05-11 |
| 598 | SUPPL | 2009-05-06 |
| 597 | SUPPL | 2003-11-05 |
| 13149 | SUPPL | 2002-11-14 |