Application 209058
- Type
- ANDA
- Sponsor
- GLAND PHARMA LTD
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | ETOMIDATE | ETOMIDATE | INJECTABLE;INJECTION | 2MG/ML | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 68083-234 | Etomidate | Etomidate Injection | Gland Pharma Limited | ANDA | Current |
| 68083-235 | Etomidate | Etomidate Injection | Gland Pharma Limited | ANDA | Current |
| 70518-1003 | Etomidate | etomidate | REMEDYREPACK INC. | ANDA | Current |
| 70518-3203 | Etomidate | Etomidate Injection | REMEDYREPACK INC. | ANDA | Current |
| 70860-652 | Etomidate | etomidate | Athenex Pharmaceutical Division, LLC. | ANDA | Current |
| 70860-652 | Etomidate | etomidate | Athenex Pharmaceutical Division, LLC. | ANDA | Current |
| 72266-146 | Etomidate | Etomidate Injection | Fosun Pharma USA Inc | ANDA | Current |
| 72266-146 | Etomidate | Etomidate Injection | Fosun Pharma USA Inc | ANDA | Current |
| 72266-147 | Etomidate | Etomidate Injection | Fosun Pharma USA Inc | ANDA | Current |
| 72266-147 | Etomidate | Etomidate Injection | Fosun Pharma USA Inc | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 48074 | ORIG | 2017-04-21 |