Application 022408
- Type
- NDA
- Sponsor
- PARAPRO LLC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | NATROBA | SPINOSAD | SUSPENSION;TOPICAL | 0.9% | Yes | Yes |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 28595-570 | Spinosad | spinosad | Allegis Pharmaceuticals, LLC | NDA | Current |
| 28595-570 | Spinosad | spinosad | Allegis Pharmaceuticals, LLC | NDA | Current |
| 28595-570 | Spinosad | spinosad | Allegis Pharmaceuticals, LLC | NDA | Current |
| 52246-929 | Natroba | spinosad | ParaPRO LLC | NDA | Current |
| 52246-929 | Natroba | spinosad | ParaPRO LLC | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 67380 | SUPPL | 2021-05-03 |
| 67276 | SUPPL | 2021-04-30 |
| 7340 | SUPPL | 2015-01-07 |
| 38668 | SUPPL | 2015-01-05 |
| 24299 | ORIG | 2011-02-17 |
| 42511 | ORIG | 2011-02-16 |
| 29698 | ORIG | 2011-01-20 |
| 17552 | ORIG | 2011-01-19 |
| 68902 | SUPPL | 1900-01-01 |
| 67208 | SUPPL | 1900-01-01 |
| 67207 | SUPPL | 1900-01-01 |
| 63562 | ORIG | 1900-01-01 |
| 63561 | ORIG | 1900-01-01 |
| 63560 | ORIG | 1900-01-01 |
| 63559 | ORIG | 1900-01-01 |
| 51488 | SUPPL | 1900-01-01 |
| 51483 | SUPPL | 1900-01-01 |