Application 205920
- Type
- NDA
- Sponsor
- ARMSTRONG PHARMS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | PRIMATENE MIST | EPINEPHRINE | AEROSOL, METERED;INHALATION | 0.125MG/INH | Yes | Yes |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 17270-553 | Primatene Mist | Epinephrine Inhalation | Armstrong Pharmaceuticals, Inc. | NDA | Current |
| 17270-553 | Primatene Mist | Epinephrine Inhalation | Armstrong Pharmaceuticals, Inc. | NDA | Current |
| 17270-553 | Primatene Mist | Epinephrine Inhalation | Armstrong Pharmaceuticals, Inc. | NDA | Current |