Application 022510
- Type
- NDA
- Sponsor
- SENTYNL THERAPS INC
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | ABSTRAL | FENTANYL CITRATE | TABLET;SUBLINGUAL | EQ 0.1MG BASE | Yes | No |
| 002 | ABSTRAL | FENTANYL CITRATE | TABLET;SUBLINGUAL | EQ 0.2MG BASE | Yes | No |
| 003 | ABSTRAL | FENTANYL CITRATE | TABLET;SUBLINGUAL | EQ 0.3MG BASE | Yes | No |
| 004 | ABSTRAL | FENTANYL CITRATE | TABLET;SUBLINGUAL | EQ 0.4MG BASE | Yes | No |
| 005 | ABSTRAL | FENTANYL CITRATE | TABLET;SUBLINGUAL | EQ 0.6MG BASE | Yes | No |
| 006 | ABSTRAL | FENTANYL CITRATE | TABLET;SUBLINGUAL | EQ 0.8MG BASE | Yes | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 42358-100 | Abstral | fentanyl citrate | Sentynl Therapeutics, Inc. | NDA | Current |
| 42358-100 | Abstral | fentanyl citrate | Sentynl Therapeutics, Inc. | NDA | Current |
| 42358-100 | Abstral | fentanyl citrate | Sentynl Therapeutics, Inc. | NDA | Current |
| 42358-200 | Abstral | fentanyl citrate | Sentynl Therapeutics, Inc. | NDA | Current |
| 42358-200 | Abstral | fentanyl citrate | Sentynl Therapeutics, Inc. | NDA | Current |
| 42358-200 | Abstral | fentanyl citrate | Sentynl Therapeutics, Inc. | NDA | Current |
| 42358-300 | Abstral | fentanyl citrate | Sentynl Therapeutics, Inc. | NDA | Current |
| 42358-300 | Abstral | fentanyl citrate | Sentynl Therapeutics, Inc. | NDA | Current |
| 42358-400 | Abstral | fentanyl citrate | Sentynl Therapeutics, Inc. | NDA | Current |
| 42358-400 | Abstral | fentanyl citrate | Sentynl Therapeutics, Inc. | NDA | Current |
| 42358-400 | Abstral | fentanyl citrate | Sentynl Therapeutics, Inc. | NDA | Current |
| 42358-600 | Abstral | fentanyl citrate | Sentynl Therapeutics, Inc. | NDA | Current |
| 42358-600 | Abstral | fentanyl citrate | Sentynl Therapeutics, Inc. | NDA | Current |
| 42358-600 | Abstral | fentanyl citrate | Sentynl Therapeutics, Inc. | NDA | Current |
| 42358-800 | Abstral | fentanyl citrate | Sentynl Therapeutics, Inc. | NDA | Current |
| 42358-800 | Abstral | fentanyl citrate | Sentynl Therapeutics, Inc. | NDA | Current |
| 42358-800 | Abstral | fentanyl citrate | Sentynl Therapeutics, Inc. | NDA | Current |
| 42747-221 | Abstral | fentanyl | ProStrakan, Inc. | NDA | Current |
| 42747-222 | Abstral | fentanyl | ProStrakan, Inc. | NDA | Current |
| 42747-223 | Abstral | fentanyl | ProStrakan, Inc. | NDA | Current |
| 42747-224 | Abstral | fentanyl | ProStrakan, Inc. | NDA | Current |
| 42747-226 | Abstral | fentanyl | ProStrakan, Inc. | NDA | Current |
| 42747-228 | Abstral | fentanyl | ProStrakan, Inc. | NDA | Current |
| 57881-331 | Abstral | fentanyl citrate | Galena Biopharma, Inc. | NDA | Current |
| 57881-332 | Abstral | fentanyl citrate | Galena Biopharma, Inc. | NDA | Current |
| 57881-333 | Abstral | fentanyl citrate | Galena Biopharma, Inc. | NDA | Current |
| 57881-334 | Abstral | fentanyl citrate | Galena Biopharma, Inc. | NDA | Current |
| 57881-336 | Abstral | fentanyl citrate | Galena Biopharma, Inc. | NDA | Current |
| 57881-338 | Abstral | fentanyl citrate | Galena Biopharma, Inc. | NDA | Current |