Application 071949
- Type
- ANDA
- Sponsor
- QUAD PHARMS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | KETAMINE HCL | KETAMINE HYDROCHLORIDE | Injectable; Injection | EQ 10MG BASE/ML | No | No |
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| KETAMINE HYDROCHLORIDE | KETAMINE HYDROCHLORIDE | Henry Schein, Inc. | 76d6aad3-0515-49da-a6e1-3fe2a1938a24 | 2026-09-08 | Warnings, Adverse reactions | KETAMINE HYDROCHLORIDE |
| Ketamine Hydrochloride | KETAMINE HYDROCHLORIDE | Civica, Inc. | 58c86d9b-8694-4bd8-8254-f19ee3ad60b0 | 2026-06-09 | Warnings, Adverse reactions | KETAMINE HYDROCHLORIDE |
| Ketamine Hydrochloride | KETAMINE HYDROCHLORIDE | Hospira, Inc. | bb912318-2e22-4469-b0a2-774803ee1bb8 | 2026-05-12 | Warnings, Adverse reactions | KETAMINE HYDROCHLORIDE |
| Ketamine Hydrochloride | KETAMINE HYDROCHLORIDE | Gland Pharma Limited | b96a0a23-3ca0-4a92-bd8b-1e9921931772 | 2026-04-16 | Warnings, Adverse reactions | KETAMINE HYDROCHLORIDE |
| Ketalar | KETAMINE HYDROCHLORIDE | Par Health USA, LLC | 14e8f864-8b8a-4e7e-8439-e510d3107063 | 2026-03-27 | Warnings, Adverse reactions | KETAMINE HYDROCHLORIDE |
| ketamine hydrochloride | KETAMINE HYDROCHLORIDE | Fresenius Kabi USA, LLC | ac2e715d-251c-4e3f-b91c-972f466d0beb | 2025-10-03 | Warnings, Adverse reactions | KETAMINE HYDROCHLORIDE |
| KETAMINE HYDROCHLORIDE | KETAMINE HYDROCHLORIDE | Baxter Healthcare Corporation | 549d6ed3-3c9b-4ea2-8aaf-f61d43e04602 | 2025-06-26 | Warnings, Adverse reactions | KETAMINE HYDROCHLORIDE |
| ketamine hydrochloride | KETAMINE HYDROCHLORIDE | Fresenius Kabi USA, LLC | cc67b0fd-ca73-49f6-b5ca-705dc7331776 | 2025-04-23 | Warnings, Adverse reactions | KETAMINE HYDROCHLORIDE |
| KETALAR | KETAMINE HYDROCHLORIDE | Henry Schein, Inc | 46dab560-8ecd-4d92-8c92-6baa2310b09b | 2025-01-27 | Warnings, Adverse reactions | KETAMINE HYDROCHLORIDE |
| Ketamine Hydrochloride | KETAMINE HYDROCHLORIDE | Hikma Pharmaceuticals USA Inc. | 58487c78-a641-4278-acc0-343596ee8683 | 2024-02-26 | Warnings, Adverse reactions | KETAMINE HYDROCHLORIDE |
| Ketamine Hydrochloride | KETAMINE HYDROCHLORIDE | Sagent Pharmaceuticals | 902c3785-a3cb-472b-ac15-394ac646271d | 2023-05-01 | Warnings, Adverse reactions | KETAMINE HYDROCHLORIDE |
| Ketamine Hydrochloride | KETAMINE HYDROCHLORIDE | Medical Purchasing Solutions, LLC | c8e90cec-621e-f8d8-e053-2a95a90a49d4 | 2023-04-27 | Warnings, Adverse reactions | KETAMINE HYDROCHLORIDE |
| Ketamine Hydrochloride | KETAMINE HYDROCHLORIDE | Medical Purchasing Solutions, LLC | ea600f8a-857f-4e0e-e053-2995a90a017d | 2023-04-24 | Warnings, Adverse reactions | KETAMINE HYDROCHLORIDE |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.