Application 020859
- Type
- NDA
- Sponsor
- PFIZER
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | SONATA | ZALEPLON | CAPSULE;ORAL | 5MG | Yes | No |
| 002 | SONATA | ZALEPLON | CAPSULE;ORAL | 10MG | Yes | Yes |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 21695-105 | ZALEPLON | ZALEPLON | Rebel Distributors Corp. | NDA | Current |
| 21695-376 | ZALEPLON | ZALEPLON | Rebel Distributors Corp. | NDA | Current |
| 60793-145 | Sonata | zaleplon | Pfizer Laboratories Div Pfizer Inc | NDA | Current |
| 60793-146 | Sonata | zaleplon | Pfizer Laboratories Div Pfizer Inc | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 59764 | SUPPL | 2019-08-20 |
| 59763 | SUPPL | 2019-08-20 |
| 59755 | SUPPL | 2019-08-20 |
| 57607 | SUPPL | 2019-02-14 |
| 57487 | SUPPL | 2019-02-07 |
| 57486 | SUPPL | 2019-02-07 |
| 23200 | ORIG | 2013-04-26 |
| 3593 | SUPPL | 2013-04-24 |
| 35522 | SUPPL | 2013-04-23 |
| 3592 | SUPPL | 2008-01-09 |
| 3591 | SUPPL | 2008-01-09 |
| 35521 | SUPPL | 2007-12-14 |
| 13628 | SUPPL | 2007-12-14 |
| 23606 | ORIG | 2003-12-12 |
| 26068 | SUPPL | 2003-06-08 |
| 26067 | SUPPL | 2003-06-08 |
| 3589 | SUPPL | 2002-06-03 |
| 3590 | SUPPL | 2002-05-31 |
| 35520 | SUPPL | 2001-02-22 |
| 3588 | SUPPL | 2001-02-22 |
| 21025 | ORIG | 2000-07-03 |
| 35519 | ORIG | 1999-08-13 |
| 3587 | ORIG | 1999-08-13 |