Application 016812
- Type
- NDA
- Sponsor
- PAR STERILE PRODUCTS
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | KETALAR | KETAMINE HYDROCHLORIDE | INJECTABLE;INJECTION | EQ 10MG BASE/ML | Yes | Yes |
| 002 | KETALAR | KETAMINE HYDROCHLORIDE | INJECTABLE;INJECTION | EQ 50MG BASE/ML | Yes | Yes |
| 003 | KETALAR | KETAMINE HYDROCHLORIDE | INJECTABLE;INJECTION | EQ 100MG BASE/ML | Yes | Yes |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 0404-9880 | KETALAR | ketamine hydrochloride | Henry Schein, Inc | NDA | Current |
| 0404-9880 | KETALAR | ketamine hydrochloride | Henry Schein, Inc | NDA | Current |
| 42023-113 | Ketalar | ketamine hydrochloride | Par Pharmaceutical, Inc. | NDA | Current |
| 42023-113 | Ketalar | ketamine hydrochloride | Par Pharmaceutical, Inc. | NDA | Current |
| 42023-113 | Ketalar | ketamine hydrochloride | Par Pharmaceutical, Inc. | NDA | Current |
| 42023-113 | Ketalar | ketamine hydrochloride | Par Pharmaceutical, Inc. | NDA | Current |
| 42023-114 | Ketalar | ketamine hydrochloride | Par Pharmaceutical, Inc. | NDA | Current |
| 42023-114 | Ketalar | ketamine hydrochloride | Par Pharmaceutical, Inc. | NDA | Current |
| 42023-114 | Ketalar | ketamine hydrochloride | Par Pharmaceutical, Inc. | NDA | Current |
| 42023-114 | Ketalar | ketamine hydrochloride | Par Pharmaceutical, Inc. | NDA | Current |
| 42023-115 | Ketalar | ketamine hydrochloride | Par Pharmaceutical, Inc. | NDA | Current |
| 42023-115 | Ketalar | ketamine hydrochloride | Par Pharmaceutical, Inc. | NDA | Current |
| 42023-115 | Ketalar | ketamine hydrochloride | Par Pharmaceutical, Inc. | NDA | Current |
| 42023-115 | Ketalar | ketamine hydrochloride | Par Pharmaceutical, Inc. | NDA | Current |
| 52584-037 | KETALAR | ketamine hydrochloride | General Injectables & Vaccines, Inc | NDA | Current |
| 52584-037 | KETALAR | ketamine hydrochloride | General Injectables & Vaccines, Inc | NDA | Current |
| 52584-037 | KETALAR | ketamine hydrochloride | General Injectables & Vaccines, Inc | NDA | Current |
| 52584-037 | KETALAR | ketamine hydrochloride | General Injectables & Vaccines, Inc | NDA | Current |
| 52584-037 | KETALAR | ketamine hydrochloride | General Injectables & Vaccines, Inc | NDA | Current |
| 52584-037 | KETALAR | ketamine hydrochloride | General Injectables & Vac | NDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 85520 | SUPPL | 2026-03-24 |
| 85519 | SUPPL | 2026-03-24 |
| 84026 | SUPPL | 2025-10-31 |
| 83999 | SUPPL | 2025-10-31 |
| 72046 | SUPPL | 2022-09-08 |
| 71253 | SUPPL | 2022-06-08 |
| 71218 | SUPPL | 2022-06-06 |
| 64409 | SUPPL | 2020-08-25 |
| 64402 | SUPPL | 2020-08-25 |
| 55139 | SUPPL | 2018-08-09 |
| 48217 | SUPPL | 2017-05-02 |
| 48189 | SUPPL | 2017-05-02 |
| 500 | SUPPL | 2012-03-13 |
| 33199 | SUPPL | 2012-03-09 |
| 499 | SUPPL | 2003-07-31 |