Application 213209
- Type
- ANDA
- Sponsor
- DR REDDYS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | NALOXONE HYDROCHLORIDE | NALOXONE HYDROCHLORIDE | INJECTABLE;INJECTION | 1MG/ML | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 43598-750 | Naloxone Hydrochloride | Naloxone Hydrochloride | Dr. Reddy | ANDA | Current |
| 51662-1529 | NALOXONE HYDROCHLORIDE | NALOXONE HYDROCHLORIDE | HF Acquisition Co LLC, DBA HealthFirst | ANDA | Current |
| 51662-1529 | NALOXONE HYDROCHLORIDE | NALOXONE HYDROCHLORIDE | HF Acquisition Co LLC, DBA HealthFirst | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 62989 | ORIG | 2020-05-14 |