Home Applications 216206 Application 216206
Type ANDA
Sponsor HIKMA Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 NEOSTIGMINE METHYLSULFATE NEOSTIGMINE METHYLSULFATE SOLUTION;INTRAVENOUS 3MG/3ML (1MG/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 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A216206-001 NEOSTIGMINE METHYLSULFATE NEOSTIGMINE METHYLSULFATE 3MG/3ML (1MG/ML) SOLUTION / INTRAVENOUS 2022-07-13
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.
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 A216206-001 NEOSTIGMINE METHYLSULFATE 3MG/3ML (1MG/ML) SOLUTION / INTRAVENOUS 2022-07-13 84e616aacf4f…2026-08-18 06:07:40 2026-07 A216206-001 NEOSTIGMINE METHYLSULFATE 3MG/3ML (1MG/ML) SOLUTION / INTRAVENOUS 2022-07-13 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A216206-001 NEOSTIGMINE METHYLSULFATE 3MG/3ML (1MG/ML) SOLUTION / INTRAVENOUS AP 2022-07-13 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A216206-001 NEOSTIGMINE METHYLSULFATE 3MG/3ML (1MG/ML) SOLUTION / INTRAVENOUS AP 2022-07-13 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A216206-001 NEOSTIGMINE METHYLSULFATE 3MG/3ML (1MG/ML) SOLUTION / INTRAVENOUS AP 2022-07-13 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A216206-001 NEOSTIGMINE METHYLSULFATE 3MG/3ML (1MG/ML) SOLUTION / INTRAVENOUS AP 2022-07-13 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A216206-001 NEOSTIGMINE METHYLSULFATE 3MG/3ML (1MG/ML) SOLUTION / INTRAVENOUS AP 2022-07-13 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A216206-001 NEOSTIGMINE METHYLSULFATE 3MG/3ML (1MG/ML) SOLUTION / INTRAVENOUS AP 2022-07-13 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A216206-001 NEOSTIGMINE METHYLSULFATE 3MG/3ML (1MG/ML) SOLUTION / INTRAVENOUS AP 2022-07-13 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A216206-001 NEOSTIGMINE METHYLSULFATE 3MG/3ML (1MG/ML) SOLUTION / INTRAVENOUS AP 2022-07-13 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A216206-001 NEOSTIGMINE METHYLSULFATE 3MG/3ML (1MG/ML) SOLUTION / INTRAVENOUS AP 2022-07-13 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A216206-001 NEOSTIGMINE METHYLSULFATE 3MG/3ML (1MG/ML) SOLUTION / INTRAVENOUS AP 2022-07-13 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A216206-001 NEOSTIGMINE METHYLSULFATE 3MG/3ML (1MG/ML) SOLUTION / INTRAVENOUS AP 2022-07-13 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A216206-001 NEOSTIGMINE METHYLSULFATE 3MG/3ML (1MG/ML) SOLUTION / INTRAVENOUS AP 2022-07-13 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A216206-001 NEOSTIGMINE METHYLSULFATE 3MG/3ML (1MG/ML) SOLUTION / INTRAVENOUS AP 2022-07-13 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A216206-001 NEOSTIGMINE METHYLSULFATE 3MG/3ML (1MG/ML) SOLUTION / INTRAVENOUS AP 2022-07-13 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A216206-001 NEOSTIGMINE METHYLSULFATE 3MG/3ML (1MG/ML) SOLUTION / INTRAVENOUS AP 2022-07-13 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A216206-001 NEOSTIGMINE METHYLSULFATE 3MG/3ML (1MG/ML) SOLUTION / INTRAVENOUS AP 2022-07-13 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A216206-001 NEOSTIGMINE METHYLSULFATE 3MG/3ML (1MG/ML) SOLUTION / INTRAVENOUS AP 2022-07-13 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A216206-001 NEOSTIGMINE METHYLSULFATE 3MG/3ML (1MG/ML) SOLUTION / INTRAVENOUS AP 2022-07-13 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A216206-001 NEOSTIGMINE METHYLSULFATE 3MG/3ML (1MG/ML) SOLUTION / INTRAVENOUS AP 2022-07-13 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A216206-001 NEOSTIGMINE METHYLSULFATE 3MG/3ML (1MG/ML) SOLUTION / INTRAVENOUS AP 2022-07-13 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A216206-001 NEOSTIGMINE METHYLSULFATE 3MG/3ML (1MG/ML) SOLUTION / INTRAVENOUS AP 2022-07-13 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A216206-001 NEOSTIGMINE METHYLSULFATE 3MG/3ML (1MG/ML) SOLUTION / INTRAVENOUS AP 2022-07-13 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A216206-001 NEOSTIGMINE METHYLSULFATE 3MG/3ML (1MG/ML) SOLUTION / INTRAVENOUS AP 2022-07-13 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A216206-001 NEOSTIGMINE METHYLSULFATE 3MG/3ML (1MG/ML) SOLUTION / INTRAVENOUS AP 2022-07-13 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A216206-001 NEOSTIGMINE METHYLSULFATE 3MG/3ML (1MG/ML) SOLUTION / INTRAVENOUS AP 2022-07-13 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A216206-001 NEOSTIGMINE METHYLSULFATE 3MG/3ML (1MG/ML) SOLUTION / INTRAVENOUS AP 2022-07-13 e64feba35796…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A216206-001 NEOSTIGMINE METHYLSULFATE 3MG/3ML (1MG/ML) SOLUTION / INTRAVENOUS 2022-07-13 a50c72e98297…
Observed Orange Book normalized TE history# 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 2 of 2 · 29 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Neostigmine Methylsulfate NEOSTIGMINE METHYLSULFATE Medical Purchasing Solutions, LLC ea6027ca-aac5-c33a-e053-2995a90a87fc 2023-05-03 Warnings, Adverse reactions Name fallback brand name: Neostigmine Methylsulfate generic name: NEOSTIGMINE METHYLSULFATE Neostigmine Methylsulfate NEOSTIGMINE METHYLSULFATE Fresenius Kabi USA, LLC 6448229c-e650-47ba-bb00-cba3604502c5 2022-12-13 Warnings, Adverse reactions Name fallback brand name: Neostigmine Methylsulfate generic name: NEOSTIGMINE METHYLSULFATE Neostigmine methylsulfate NEOSTIGMINE METHYLSULFATE BE Pharmaceuticals Inc. 971713db-d5ac-44c1-ada5-a56a943d79bf 2022-02-18 Warnings, Adverse reactions Name fallback brand name: Neostigmine methylsulfate generic name: NEOSTIGMINE METHYLSULFATE Neostigmine Methylsulfate NEOSTIGMINE METHYLSULFATE Somerset Therapeutics, LLC ea767851-b0ab-4a4c-a4b2-680ff4086636 2021-10-26 Warnings, Adverse reactions Name fallback brand name: Neostigmine Methylsulfate generic name: NEOSTIGMINE METHYLSULFATE Neostigmine Methylsulfate NEOSTIGMINE METHYLSULFATE Xellia Pharmaceuticals USA LLC 398d8193-e1e8-42b5-a95a-86cde967c7d0 2021-10-25 Warnings, Adverse reactions Name fallback brand name: Neostigmine Methylsulfate generic name: NEOSTIGMINE METHYLSULFATE Neostigmine methylsulfate NEOSTIGMINE METHYLSULFATE Xiromed LLC 801225d9-eb71-dbef-e860-4caf7a22f27f 2021-10-13 Warnings, Adverse reactions Name fallback brand name: Neostigmine methylsulfate generic name: NEOSTIGMINE METHYLSULFATE Neostigmine Methylsulfate NEOSTIGMINE METHYLSULFATE Caplin Steriles Limited 11f38ea2-be55-4119-8eee-776f84c5e7f8 2021-04-26 Warnings, Adverse reactions Name fallback brand name: Neostigmine Methylsulfate generic name: NEOSTIGMINE METHYLSULFATE neostigmine methylsulfate NEOSTIGMINE METHYLSULFATE Camber Pharmaceuticals Inc. d07ff23f-54a5-4036-8005-a3515d4e2194 2021-04-22 Warnings, Adverse reactions Name fallback brand name: neostigmine methylsulfate generic name: NEOSTIGMINE METHYLSULFATE neostigmine methylsulfate NEOSTIGMINE METHYLSULFATE Meitheal Pharmaceuticals Inc. 5a01a429-a346-4253-8994-b58d34b57974 2021-04-05 Warnings, Adverse reactions Name fallback brand name: neostigmine methylsulfate generic name: NEOSTIGMINE METHYLSULFATE
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 · 1 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0641-6240 Neostigmine Methylsulfate Neostigmine Methylsulfate Hikma Pharmaceuticals USA Inc. ANDA Current