Application 214785
- Type
- ANDA
- Sponsor
- BAXTER HLTHCARE CORP
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | NALOXONE HYDROCHLORIDE | NALOXONE HYDROCHLORIDE | INJECTABLE;INJECTION | 0.4MG/ML | No | No |
| 002 | NALOXONE HYDROCHLORIDE | NALOXONE HYDROCHLORIDE | INJECTABLE;INJECTION | 1MG/ML | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 36000-308 | naloxone hydrochloride | naloxone hydrochloride | Baxter Healthcare Corporation | ANDA | Current |
| 36000-308 | naloxone hydrochloride | naloxone hydrochloride | Baxter Healthcare Corporation | ANDA | Current |
| 36000-308 | naloxone hydrochloride | naloxone hydrochloride | Baxter Healthcare Corporation | ANDA | Current |
| 36000-308 | naloxone hydrochloride | naloxone hydrochloride | Baxter Healthcare Corporation | ANDA | Current |
| 36000-308 | naloxone hydrochloride | naloxone hydrochloride | Baxter Healthcare Corporation | ANDA | Current |