Application 208230
- Type
- ANDA
- Sponsor
- AVET LIFESCIENCES
Application Products#
| 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 |
Orange Book products#
| 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#
| Application-product | TE code |
|---|---|
| A208230-001 | AP |
| A208230-002 | AP |
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 | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-10-15 13:18:30 | 2026-09 | A208230-001 | NEOSTIGMINE METHYLSULFATE | 5MG/10ML (0.5MG/ML) | SOLUTION / INTRAVENOUS | AP | 2022-11-25 | c2088c7a36db… | |
| 2026-10-15 13:18:30 | 2026-09 | A208230-002 | NEOSTIGMINE METHYLSULFATE | 10MG/10ML (1MG/ML) | SOLUTION / INTRAVENOUS | AP | 2022-11-25 | c2088c7a36db… | |
| 2026-09-14 22:38:34 | 2026-08 | A208230-001 | NEOSTIGMINE METHYLSULFATE | 5MG/10ML (0.5MG/ML) | SOLUTION / INTRAVENOUS | AP | 2022-11-25 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A208230-002 | NEOSTIGMINE METHYLSULFATE | 10MG/10ML (1MG/ML) | SOLUTION / INTRAVENOUS | AP | 2022-11-25 | 84e616aacf4f… | |
| 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… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-10-15 13:18:30 | 2026-09 | A208230-001 | AP | 1 | c2088c7a36db… |
| 2026-10-15 13:18:30 | 2026-09 | A208230-002 | AP | 1 | c2088c7a36db… |
| 2026-09-14 22:38:34 | 2026-08 | A208230-001 | AP | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A208230-002 | AP | 1 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | A208230-001 | AP | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A208230-002 | AP | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A208230-001 | AP | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A208230-002 | AP | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A208230-001 | AP | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A208230-002 | AP | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A208230-001 | AP | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A208230-002 | AP | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A208230-001 | AP | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A208230-002 | AP | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A208230-001 | AP | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A208230-002 | AP | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A208230-001 | AP | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A208230-002 | AP | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A208230-001 | AP | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A208230-002 | AP | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A208230-001 | AP | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A208230-002 | AP | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A208230-001 | AP | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A208230-002 | AP | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A208230-001 | AP | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A208230-002 | AP | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A208230-001 | AP | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A208230-002 | AP | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A208230-001 | AP | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A208230-002 | AP | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A208230-001 | AP | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A208230-002 | AP | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A208230-001 | AP | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | A208230-002 | AP | 1 | 8072bd15b7f6… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A208230-001 | AP | 1 | 6a51e52b5d6a… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A208230-002 | AP | 1 | 6a51e52b5d6a… |
| 2024-02-18 07:12 UTC | 2024-02 | A208230-001 | AP | 1 | 1c564ffb4f44… |
| 2024-02-18 07:12 UTC | 2024-02 | A208230-002 | AP | 1 | 1c564ffb4f44… |
| 2023-12-20 04:57 UTC | 2023-12 | A208230-001 | AP | 1 | ea1830bbd6c7… |
| 2023-12-20 04:57 UTC | 2023-12 | A208230-002 | AP | 1 | ea1830bbd6c7… |
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 |
|---|---|---|---|---|---|---|
| Neostigmine methylsulfate | NEOSTIGMINE METHYLSULFATE | BE Pharmaceuticals Inc. | 971713db-d5ac-44c1-ada5-a56a943d79bf | 2022-02-18 | Warnings, Adverse reactions | NEOSTIGMINE METHYLSULFATE |
| Neostigmine Methylsulfate | NEOSTIGMINE METHYLSULFATE | Somerset Therapeutics, LLC | ea767851-b0ab-4a4c-a4b2-680ff4086636 | 2021-10-26 | Warnings, Adverse reactions | NEOSTIGMINE METHYLSULFATE |
| Neostigmine Methylsulfate | NEOSTIGMINE METHYLSULFATE | Xellia Pharmaceuticals USA LLC | 398d8193-e1e8-42b5-a95a-86cde967c7d0 | 2021-10-25 | Warnings, Adverse reactions | NEOSTIGMINE METHYLSULFATE |
| Neostigmine methylsulfate | NEOSTIGMINE METHYLSULFATE | Xiromed LLC | 801225d9-eb71-dbef-e860-4caf7a22f27f | 2021-10-13 | Warnings, Adverse reactions | NEOSTIGMINE METHYLSULFATE |
| Neostigmine Methylsulfate | NEOSTIGMINE METHYLSULFATE | Caplin Steriles Limited | 11f38ea2-be55-4119-8eee-776f84c5e7f8 | 2021-04-26 | Warnings, Adverse reactions | NEOSTIGMINE METHYLSULFATE |
| neostigmine methylsulfate | NEOSTIGMINE METHYLSULFATE | Camber Pharmaceuticals Inc. | d07ff23f-54a5-4036-8005-a3515d4e2194 | 2021-04-22 | Warnings, Adverse reactions | NEOSTIGMINE METHYLSULFATE |
| neostigmine methylsulfate | NEOSTIGMINE METHYLSULFATE | Meitheal Pharmaceuticals Inc. | 5a01a429-a346-4253-8994-b58d34b57974 | 2021-04-05 | Warnings, Adverse reactions | NEOSTIGMINE METHYLSULFATE |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
NDC Listings For This Application#
| 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 |