Home Applications 208230 Application 208230
Type ANDA
Sponsor AVET LIFESCIENCES Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 NEOSTIGMINE METHYSULFATE NEOSTIGMINE METHYLSULFATE SOLUTION;INTRAVENOUS 5MG/10ML (0.5MG/ML) No No 002 NEOSTIGMINE METHYSULFATE NEOSTIGMINE METHYLSULFATE SOLUTION;INTRAVENOUS 10MG/10ML (1MG/ML) No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A208230-001 NEOSTIGMINE METHYLSULFATE NEOSTIGMINE METHYLSULFATE 5MG/10ML (0.5MG/ML) SOLUTION / INTRAVENOUS AP 2022-11-25 A208230-002 NEOSTIGMINE METHYLSULFATE NEOSTIGMINE METHYLSULFATE 10MG/10ML (1MG/ML) SOLUTION / INTRAVENOUS AP 2022-11-25
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 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 2 · 50 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 2026-08-18 06:07:40 2026-07 A208230-001 NEOSTIGMINE METHYLSULFATE 5MG/10ML (0.5MG/ML) SOLUTION / INTRAVENOUS AP 2022-11-25 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A208230-002 NEOSTIGMINE METHYLSULFATE 10MG/10ML (1MG/ML) SOLUTION / INTRAVENOUS AP 2022-11-25 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A208230-001 NEOSTIGMINE METHYLSULFATE 5MG/10ML (0.5MG/ML) SOLUTION / INTRAVENOUS AP 2022-11-25 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A208230-002 NEOSTIGMINE METHYLSULFATE 10MG/10ML (1MG/ML) SOLUTION / INTRAVENOUS AP 2022-11-25 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A208230-001 NEOSTIGMINE METHYLSULFATE 5MG/10ML (0.5MG/ML) SOLUTION / INTRAVENOUS AP 2022-11-25 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A208230-002 NEOSTIGMINE METHYLSULFATE 10MG/10ML (1MG/ML) SOLUTION / INTRAVENOUS AP 2022-11-25 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A208230-001 NEOSTIGMINE METHYLSULFATE 5MG/10ML (0.5MG/ML) SOLUTION / INTRAVENOUS AP 2022-11-25 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A208230-002 NEOSTIGMINE METHYLSULFATE 10MG/10ML (1MG/ML) SOLUTION / INTRAVENOUS AP 2022-11-25 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A208230-001 NEOSTIGMINE METHYSULFATE 5MG/10ML (0.5MG/ML) SOLUTION / INTRAVENOUS AP 2022-11-25 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A208230-002 NEOSTIGMINE METHYSULFATE 10MG/10ML (1MG/ML) SOLUTION / INTRAVENOUS AP 2022-11-25 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A208230-001 NEOSTIGMINE METHYSULFATE 5MG/10ML (0.5MG/ML) SOLUTION / INTRAVENOUS AP 2022-11-25 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A208230-002 NEOSTIGMINE METHYSULFATE 10MG/10ML (1MG/ML) SOLUTION / INTRAVENOUS AP 2022-11-25 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A208230-001 NEOSTIGMINE METHYSULFATE 5MG/10ML (0.5MG/ML) SOLUTION / INTRAVENOUS AP 2022-11-25 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A208230-002 NEOSTIGMINE METHYSULFATE 10MG/10ML (1MG/ML) SOLUTION / INTRAVENOUS AP 2022-11-25 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A208230-001 NEOSTIGMINE METHYSULFATE 5MG/10ML (0.5MG/ML) SOLUTION / INTRAVENOUS AP 2022-11-25 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A208230-002 NEOSTIGMINE METHYSULFATE 10MG/10ML (1MG/ML) SOLUTION / INTRAVENOUS AP 2022-11-25 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A208230-001 NEOSTIGMINE METHYSULFATE 5MG/10ML (0.5MG/ML) SOLUTION / INTRAVENOUS AP 2022-11-25 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A208230-002 NEOSTIGMINE METHYSULFATE 10MG/10ML (1MG/ML) SOLUTION / INTRAVENOUS AP 2022-11-25 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A208230-001 NEOSTIGMINE METHYSULFATE 5MG/10ML (0.5MG/ML) SOLUTION / INTRAVENOUS AP 2022-11-25 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A208230-002 NEOSTIGMINE METHYSULFATE 10MG/10ML (1MG/ML) SOLUTION / INTRAVENOUS AP 2022-11-25 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A208230-001 NEOSTIGMINE METHYSULFATE 5MG/10ML (0.5MG/ML) SOLUTION / INTRAVENOUS AP 2022-11-25 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A208230-002 NEOSTIGMINE METHYSULFATE 10MG/10ML (1MG/ML) SOLUTION / INTRAVENOUS AP 2022-11-25 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A208230-001 NEOSTIGMINE METHYSULFATE 5MG/10ML (0.5MG/ML) SOLUTION / INTRAVENOUS AP 2022-11-25 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A208230-002 NEOSTIGMINE METHYSULFATE 10MG/10ML (1MG/ML) SOLUTION / INTRAVENOUS AP 2022-11-25 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A208230-001 NEOSTIGMINE METHYSULFATE 5MG/10ML (0.5MG/ML) SOLUTION / INTRAVENOUS AP 2022-11-25 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A208230-002 NEOSTIGMINE METHYSULFATE 10MG/10ML (1MG/ML) SOLUTION / INTRAVENOUS AP 2022-11-25 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A208230-001 NEOSTIGMINE METHYSULFATE 5MG/10ML (0.5MG/ML) SOLUTION / INTRAVENOUS AP 2022-11-25 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A208230-002 NEOSTIGMINE METHYSULFATE 10MG/10ML (1MG/ML) SOLUTION / INTRAVENOUS AP 2022-11-25 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A208230-001 NEOSTIGMINE METHYSULFATE 5MG/10ML (0.5MG/ML) SOLUTION / INTRAVENOUS AP 2022-11-25 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A208230-002 NEOSTIGMINE METHYSULFATE 10MG/10ML (1MG/ML) SOLUTION / INTRAVENOUS AP 2022-11-25 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A208230-001 NEOSTIGMINE METHYSULFATE 5MG/10ML (0.5MG/ML) SOLUTION / INTRAVENOUS AP 2022-11-25 6a51e52b5d6a…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A208230-002 NEOSTIGMINE METHYSULFATE 10MG/10ML (1MG/ML) SOLUTION / INTRAVENOUS AP 2022-11-25 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A208230-001 NEOSTIGMINE METHYSULFATE 5MG/10ML (0.5MG/ML) SOLUTION / INTRAVENOUS AP 2022-11-25 1c564ffb4f44…2024-02-18 07:12 UTC 2024-02 A208230-002 NEOSTIGMINE METHYSULFATE 10MG/10ML (1MG/ML) SOLUTION / INTRAVENOUS AP 2022-11-25 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A208230-001 NEOSTIGMINE METHYSULFATE 5MG/10ML (0.5MG/ML) SOLUTION / INTRAVENOUS AP 2022-11-25 ea1830bbd6c7…2023-12-20 04:57 UTC 2023-12 A208230-002 NEOSTIGMINE METHYSULFATE 10MG/10ML (1MG/ML) SOLUTION / INTRAVENOUS AP 2022-11-25 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A208230-001 NEOSTIGMINE METHYSULFATE 5MG/10ML (0.5MG/ML) SOLUTION / INTRAVENOUS AP 2022-11-25 a72a2bbeb626…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A208230-002 NEOSTIGMINE METHYSULFATE 10MG/10ML (1MG/ML) SOLUTION / INTRAVENOUS AP 2022-11-25 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A208230-001 NEOSTIGMINE METHYSULFATE 5MG/10ML (0.5MG/ML) SOLUTION / INTRAVENOUS AP 2022-11-25 9b2671bbb829…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A208230-002 NEOSTIGMINE METHYSULFATE 10MG/10ML (1MG/ML) SOLUTION / INTRAVENOUS AP 2022-11-25 9b2671bbb829…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 50 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 · 1 matching rows.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 2 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 23155-517 Neostigmine Methylsulfate Neostigmine Methylsulfate Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. ANDA Current 23155-518 Neostigmine Methylsulfate Neostigmine Methylsulfate Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. ANDA Current