Application 209522
- Type
- ANDA
- Sponsor
- TEVA PHARMS USA
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | NALOXONE HYDROCHLORIDE | NALOXONE HYDROCHLORIDE | SPRAY, METERED;NASAL | 4MG/SPRAY | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0093-2165 | Naloxone Hydrochloride | Naloxone Hydrochloride | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0093-2165 | Naloxone Hydrochloride | Naloxone Hydrochloride | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0093-2165 | Naloxone Hydrochloride | Naloxone Hydrochloride | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 58822 | ORIG | 2019-05-22 |