Application 076092
- Type
- ANDA
- Sponsor
- MYLAN INSTITUTIONAL
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | KETAMINE HYDROCHLORIDE | KETAMINE HYDROCHLORIDE | INJECTABLE;INJECTION | EQ 10MG BASE/ML | No | No |
| 002 | KETAMINE HYDROCHLORIDE | KETAMINE HYDROCHLORIDE | INJECTABLE;INJECTION | EQ 50MG BASE/ML | No | No |
| 003 | KETAMINE HYDROCHLORIDE | KETAMINE HYDROCHLORIDE | INJECTABLE;INJECTION | EQ 100MG BASE/ML | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 52584-108 | KETAMINE HYDROCHLORIDE | ketamine hydrochloride | General Injectables and Vaccines, Inc. | ANDA | Current |
| 52584-108 | KETAMINE HYDROCHLORIDE | ketamine hydrochloride | General Injectables and Vaccines, Inc. | ANDA | Current |
| 55150-438 | KETAMINE HYDROCHLORIDE | KETAMINE HYDROCHLORIDE | AuroMedics Pharma LLC | ANDA | Current |
| 55150-438 | KETAMINE HYDROCHLORIDE | KETAMINE HYDROCHLORIDE | AuroMedics Pharma LLC | ANDA | Current |
| 55150-439 | KETAMINE HYDROCHLORIDE | KETAMINE HYDROCHLORIDE | AuroMedics Pharma LLC | ANDA | Current |
| 55150-439 | KETAMINE HYDROCHLORIDE | KETAMINE HYDROCHLORIDE | AuroMedics Pharma LLC | ANDA | Current |
| 55150-440 | KETAMINE HYDROCHLORIDE | KETAMINE HYDROCHLORIDE | AuroMedics Pharma LLC | ANDA | Current |
| 55150-440 | KETAMINE HYDROCHLORIDE | KETAMINE HYDROCHLORIDE | AuroMedics Pharma LLC | ANDA | Current |
| 67457-001 | Ketamine Hydrochloride | Ketamine Hydrochloride | Mylan Institutional LLC | ANDA | Current |
| 67457-001 | Ketamine Hydrochloride | Ketamine Hydrochloride | Mylan Institutional LLC | ANDA | Current |
| 67457-108 | Ketamine Hydrochloride | Ketamine Hydrochloride | Mylan Institutional LLC | ANDA | Current |
| 67457-108 | Ketamine Hydrochloride | Ketamine Hydrochloride | Mylan Institutional LLC | ANDA | Current |
| 67457-181 | Ketamine Hydrochloride | Ketamine Hydrochloride | Mylan Institutional LLC | ANDA | Current |
| 67457-181 | Ketamine Hydrochloride | Ketamine Hydrochloride | Mylan Institutional LLC | ANDA | Current |
| 70518-2787 | Ketamine Hydrochloride | Ketamine Hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-2787 | Ketamine Hydrochloride | Ketamine Hydrochloride | REMEDYREPACK INC. | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 43051 | ORIG | 2006-04-20 |
| 8863 | ORIG | 2003-04-16 |