Home Applications 076092 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
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
Orange Book products# Current product rows page 1 of 1 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A076092-001 KETAMINE HYDROCHLORIDE KETAMINE HYDROCHLORIDE EQ 10MG BASE/ML INJECTABLE / INJECTION AP 2008-09-30 A076092-002 KETAMINE HYDROCHLORIDE KETAMINE HYDROCHLORIDE EQ 50MG BASE/ML INJECTABLE / INJECTION AP 2001-12-28 A076092-003 KETAMINE HYDROCHLORIDE KETAMINE HYDROCHLORIDE EQ 100MG BASE/ML INJECTABLE / INJECTION AP 2002-10-25
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 3 matching rows.
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Product history page 1 of 4 · 129 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-09-14 22:38:34 2026-08 A076092-001 KETAMINE HYDROCHLORIDE EQ 10MG BASE/ML INJECTABLE / INJECTION AP 2008-09-30 84e616aacf4f…2026-09-14 22:38:34 2026-08 A076092-002 KETAMINE HYDROCHLORIDE EQ 50MG BASE/ML INJECTABLE / INJECTION AP 2001-12-28 84e616aacf4f…2026-09-14 22:38:34 2026-08 A076092-003 KETAMINE HYDROCHLORIDE EQ 100MG BASE/ML INJECTABLE / INJECTION AP 2002-10-25 84e616aacf4f…2026-08-18 06:07:40 2026-07 A076092-001 KETAMINE HYDROCHLORIDE EQ 10MG BASE/ML INJECTABLE / INJECTION AP 2008-09-30 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A076092-002 KETAMINE HYDROCHLORIDE EQ 50MG BASE/ML INJECTABLE / INJECTION AP 2001-12-28 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A076092-003 KETAMINE HYDROCHLORIDE EQ 100MG BASE/ML INJECTABLE / INJECTION AP 2002-10-25 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A076092-001 KETAMINE HYDROCHLORIDE EQ 10MG BASE/ML INJECTABLE / INJECTION AP 2008-09-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A076092-002 KETAMINE HYDROCHLORIDE EQ 50MG BASE/ML INJECTABLE / INJECTION AP 2001-12-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A076092-003 KETAMINE HYDROCHLORIDE EQ 100MG BASE/ML INJECTABLE / INJECTION AP 2002-10-25 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076092-001 KETAMINE HYDROCHLORIDE EQ 10MG BASE/ML INJECTABLE / INJECTION AP 2008-09-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076092-002 KETAMINE HYDROCHLORIDE EQ 50MG BASE/ML INJECTABLE / INJECTION AP 2001-12-28 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076092-003 KETAMINE HYDROCHLORIDE EQ 100MG BASE/ML INJECTABLE / INJECTION AP 2002-10-25 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A076092-001 KETAMINE HYDROCHLORIDE EQ 10MG BASE/ML INJECTABLE / INJECTION AP 2008-09-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A076092-002 KETAMINE HYDROCHLORIDE EQ 50MG BASE/ML INJECTABLE / INJECTION AP 2001-12-28 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A076092-003 KETAMINE HYDROCHLORIDE EQ 100MG BASE/ML INJECTABLE / INJECTION AP 2002-10-25 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076092-001 KETAMINE HYDROCHLORIDE EQ 10MG BASE/ML INJECTABLE / INJECTION AP 2008-09-30 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076092-002 KETAMINE HYDROCHLORIDE EQ 50MG BASE/ML INJECTABLE / INJECTION AP 2001-12-28 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076092-003 KETAMINE HYDROCHLORIDE EQ 100MG BASE/ML INJECTABLE / INJECTION AP 2002-10-25 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076092-001 KETAMINE HYDROCHLORIDE EQ 10MG BASE/ML INJECTABLE / INJECTION AP 2008-09-30 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076092-002 KETAMINE HYDROCHLORIDE EQ 50MG BASE/ML INJECTABLE / INJECTION AP 2001-12-28 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076092-003 KETAMINE HYDROCHLORIDE EQ 100MG BASE/ML INJECTABLE / INJECTION AP 2002-10-25 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076092-001 KETAMINE HYDROCHLORIDE EQ 10MG BASE/ML INJECTABLE / INJECTION AP 2008-09-30 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076092-002 KETAMINE HYDROCHLORIDE EQ 50MG BASE/ML INJECTABLE / INJECTION AP 2001-12-28 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076092-003 KETAMINE HYDROCHLORIDE EQ 100MG BASE/ML INJECTABLE / INJECTION AP 2002-10-25 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076092-001 KETAMINE HYDROCHLORIDE EQ 10MG BASE/ML INJECTABLE / INJECTION AP 2008-09-30 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076092-002 KETAMINE HYDROCHLORIDE EQ 50MG BASE/ML INJECTABLE / INJECTION AP 2001-12-28 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076092-003 KETAMINE HYDROCHLORIDE EQ 100MG BASE/ML INJECTABLE / INJECTION AP 2002-10-25 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076092-001 KETAMINE HYDROCHLORIDE EQ 10MG BASE/ML INJECTABLE / INJECTION AP 2008-09-30 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076092-002 KETAMINE HYDROCHLORIDE EQ 50MG BASE/ML INJECTABLE / INJECTION AP 2001-12-28 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076092-003 KETAMINE HYDROCHLORIDE EQ 100MG BASE/ML INJECTABLE / INJECTION AP 2002-10-25 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A076092-001 KETAMINE HYDROCHLORIDE EQ 10MG BASE/ML INJECTABLE / INJECTION AP 2008-09-30 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A076092-002 KETAMINE HYDROCHLORIDE EQ 50MG BASE/ML INJECTABLE / INJECTION AP 2001-12-28 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A076092-003 KETAMINE HYDROCHLORIDE EQ 100MG BASE/ML INJECTABLE / INJECTION AP 2002-10-25 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A076092-001 KETAMINE HYDROCHLORIDE EQ 10MG BASE/ML INJECTABLE / INJECTION AP 2008-09-30 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A076092-002 KETAMINE HYDROCHLORIDE EQ 50MG BASE/ML INJECTABLE / INJECTION AP 2001-12-28 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A076092-003 KETAMINE HYDROCHLORIDE EQ 100MG BASE/ML INJECTABLE / INJECTION AP 2002-10-25 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A076092-001 KETAMINE HYDROCHLORIDE EQ 10MG BASE/ML INJECTABLE / INJECTION AP 2008-09-30 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A076092-002 KETAMINE HYDROCHLORIDE EQ 50MG BASE/ML INJECTABLE / INJECTION AP 2001-12-28 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A076092-003 KETAMINE HYDROCHLORIDE EQ 100MG BASE/ML INJECTABLE / INJECTION AP 2002-10-25 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A076092-001 KETAMINE HYDROCHLORIDE EQ 10MG BASE/ML INJECTABLE / INJECTION AP 2008-09-30 301d65b070ca…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 129 observed states.
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.
Matched openFDA labels page 1 of 1 · 13 matching rows.
Brand, Generic, Manufacturer table 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 Name fallback brand name: KETAMINE HYDROCHLORIDE generic name: KETAMINE HYDROCHLORIDE Ketamine Hydrochloride KETAMINE HYDROCHLORIDE Civica, Inc. 58c86d9b-8694-4bd8-8254-f19ee3ad60b0 2026-06-09 Warnings, Adverse reactions Name fallback brand name: Ketamine Hydrochloride generic name: KETAMINE HYDROCHLORIDE Ketamine Hydrochloride KETAMINE HYDROCHLORIDE Hospira, Inc. bb912318-2e22-4469-b0a2-774803ee1bb8 2026-05-12 Warnings, Adverse reactions Name fallback brand name: Ketamine Hydrochloride generic name: KETAMINE HYDROCHLORIDE Ketamine Hydrochloride KETAMINE HYDROCHLORIDE Gland Pharma Limited b96a0a23-3ca0-4a92-bd8b-1e9921931772 2026-04-16 Warnings, Adverse reactions Name fallback brand name: Ketamine Hydrochloride generic name: KETAMINE HYDROCHLORIDE Ketalar KETAMINE HYDROCHLORIDE Par Health USA, LLC 14e8f864-8b8a-4e7e-8439-e510d3107063 2026-03-27 Warnings, Adverse reactions Name fallback generic name: KETAMINE HYDROCHLORIDE ketamine hydrochloride KETAMINE HYDROCHLORIDE Fresenius Kabi USA, LLC ac2e715d-251c-4e3f-b91c-972f466d0beb 2025-10-03 Warnings, Adverse reactions Name fallback brand name: ketamine hydrochloride generic name: KETAMINE HYDROCHLORIDE KETAMINE HYDROCHLORIDE KETAMINE HYDROCHLORIDE Baxter Healthcare Corporation 549d6ed3-3c9b-4ea2-8aaf-f61d43e04602 2025-06-26 Warnings, Adverse reactions Name fallback brand name: KETAMINE HYDROCHLORIDE generic name: KETAMINE HYDROCHLORIDE ketamine hydrochloride KETAMINE HYDROCHLORIDE Fresenius Kabi USA, LLC cc67b0fd-ca73-49f6-b5ca-705dc7331776 2025-04-23 Warnings, Adverse reactions Name fallback brand name: ketamine hydrochloride generic name: KETAMINE HYDROCHLORIDE KETALAR KETAMINE HYDROCHLORIDE Henry Schein, Inc 46dab560-8ecd-4d92-8c92-6baa2310b09b 2025-01-27 Warnings, Adverse reactions Name fallback generic name: KETAMINE HYDROCHLORIDE Ketamine Hydrochloride KETAMINE HYDROCHLORIDE Hikma Pharmaceuticals USA Inc. 58487c78-a641-4278-acc0-343596ee8683 2024-02-26 Warnings, Adverse reactions Name fallback brand name: Ketamine Hydrochloride generic name: KETAMINE HYDROCHLORIDE Ketamine Hydrochloride KETAMINE HYDROCHLORIDE Sagent Pharmaceuticals 902c3785-a3cb-472b-ac15-394ac646271d 2023-05-01 Warnings, Adverse reactions Name fallback brand name: Ketamine Hydrochloride generic name: KETAMINE HYDROCHLORIDE Ketamine Hydrochloride KETAMINE HYDROCHLORIDE Medical Purchasing Solutions, LLC c8e90cec-621e-f8d8-e053-2a95a90a49d4 2023-04-27 Warnings, Adverse reactions Name fallback brand name: Ketamine Hydrochloride generic name: KETAMINE HYDROCHLORIDE Ketamine Hydrochloride KETAMINE HYDROCHLORIDE Medical Purchasing Solutions, LLC ea600f8a-857f-4e0e-e053-2995a90a017d 2023-04-24 Warnings, Adverse reactions Name fallback brand name: Ketamine Hydrochloride generic name: KETAMINE HYDROCHLORIDE
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 16 matching rows.
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