Application 212627
- Type
- ANDA
- Sponsor
- NIVAGEN PHARMS INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | NEOSTIGMINE METHYLSULFATE | NEOSTIGMINE METHYLSULFATE | SOLUTION;INTRAVENOUS | 5MG/10ML (0.5MG/ML) | No | No |
| 002 | NEOSTIGMINE METHYLSULFATE | 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 |
|---|---|---|---|---|---|---|---|
| A212627-001 | NEOSTIGMINE METHYLSULFATE | NEOSTIGMINE METHYLSULFATE | 5MG/10ML (0.5MG/ML) | SOLUTION / INTRAVENOUS | AP | 2022-11-03 | |
| A212627-002 | NEOSTIGMINE METHYLSULFATE | NEOSTIGMINE METHYLSULFATE | 10MG/10ML (1MG/ML) | SOLUTION / INTRAVENOUS | AP | 2022-11-03 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A212627-001 | AP |
| A212627-002 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A212627-001 | NEOSTIGMINE METHYLSULFATE | 5MG/10ML (0.5MG/ML) | SOLUTION / INTRAVENOUS | AP | 2022-11-03 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A212627-002 | NEOSTIGMINE METHYLSULFATE | 10MG/10ML (1MG/ML) | SOLUTION / INTRAVENOUS | AP | 2022-11-03 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | A212627-001 | NEOSTIGMINE METHYLSULFATE | 5MG/10ML (0.5MG/ML) | SOLUTION / INTRAVENOUS | AP | 2022-11-03 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A212627-002 | NEOSTIGMINE METHYLSULFATE | 10MG/10ML (1MG/ML) | SOLUTION / INTRAVENOUS | AP | 2022-11-03 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A212627-001 | NEOSTIGMINE METHYLSULFATE | 5MG/10ML (0.5MG/ML) | SOLUTION / INTRAVENOUS | AP | 2022-11-03 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A212627-002 | NEOSTIGMINE METHYLSULFATE | 10MG/10ML (1MG/ML) | SOLUTION / INTRAVENOUS | AP | 2022-11-03 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A212627-001 | NEOSTIGMINE METHYLSULFATE | 5MG/10ML (0.5MG/ML) | SOLUTION / INTRAVENOUS | AP | 2022-11-03 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A212627-002 | NEOSTIGMINE METHYLSULFATE | 10MG/10ML (1MG/ML) | SOLUTION / INTRAVENOUS | AP | 2022-11-03 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A212627-001 | NEOSTIGMINE METHYLSULFATE | 5MG/10ML (0.5MG/ML) | SOLUTION / INTRAVENOUS | AP | 2022-11-03 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A212627-002 | NEOSTIGMINE METHYLSULFATE | 10MG/10ML (1MG/ML) | SOLUTION / INTRAVENOUS | AP | 2022-11-03 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A212627-001 | NEOSTIGMINE METHYLSULFATE | 5MG/10ML (0.5MG/ML) | SOLUTION / INTRAVENOUS | AP | 2022-11-03 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A212627-002 | NEOSTIGMINE METHYLSULFATE | 10MG/10ML (1MG/ML) | SOLUTION / INTRAVENOUS | AP | 2022-11-03 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A212627-001 | NEOSTIGMINE METHYLSULFATE | 5MG/10ML (0.5MG/ML) | SOLUTION / INTRAVENOUS | AP | 2022-11-03 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A212627-002 | NEOSTIGMINE METHYLSULFATE | 10MG/10ML (1MG/ML) | SOLUTION / INTRAVENOUS | AP | 2022-11-03 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A212627-001 | NEOSTIGMINE METHYLSULFATE | 5MG/10ML (0.5MG/ML) | SOLUTION / INTRAVENOUS | AP | 2022-11-03 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A212627-002 | NEOSTIGMINE METHYLSULFATE | 10MG/10ML (1MG/ML) | SOLUTION / INTRAVENOUS | AP | 2022-11-03 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A212627-001 | NEOSTIGMINE METHYLSULFATE | 5MG/10ML (0.5MG/ML) | SOLUTION / INTRAVENOUS | AP | 2022-11-03 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A212627-002 | NEOSTIGMINE METHYLSULFATE | 10MG/10ML (1MG/ML) | SOLUTION / INTRAVENOUS | AP | 2022-11-03 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A212627-001 | NEOSTIGMINE METHYLSULFATE | 5MG/10ML (0.5MG/ML) | SOLUTION / INTRAVENOUS | AP | 2022-11-03 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A212627-002 | NEOSTIGMINE METHYLSULFATE | 10MG/10ML (1MG/ML) | SOLUTION / INTRAVENOUS | AP | 2022-11-03 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A212627-001 | NEOSTIGMINE METHYLSULFATE | 5MG/10ML (0.5MG/ML) | SOLUTION / INTRAVENOUS | AP | 2022-11-03 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A212627-002 | NEOSTIGMINE METHYLSULFATE | 10MG/10ML (1MG/ML) | SOLUTION / INTRAVENOUS | AP | 2022-11-03 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A212627-001 | NEOSTIGMINE METHYLSULFATE | 5MG/10ML (0.5MG/ML) | SOLUTION / INTRAVENOUS | AP | 2022-11-03 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A212627-002 | NEOSTIGMINE METHYLSULFATE | 10MG/10ML (1MG/ML) | SOLUTION / INTRAVENOUS | AP | 2022-11-03 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A212627-001 | NEOSTIGMINE METHYLSULFATE | 5MG/10ML (0.5MG/ML) | SOLUTION / INTRAVENOUS | AP | 2022-11-03 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A212627-002 | NEOSTIGMINE METHYLSULFATE | 10MG/10ML (1MG/ML) | SOLUTION / INTRAVENOUS | AP | 2022-11-03 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A212627-001 | NEOSTIGMINE METHYLSULFATE | 5MG/10ML (0.5MG/ML) | SOLUTION / INTRAVENOUS | AP | 2022-11-03 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A212627-002 | NEOSTIGMINE METHYLSULFATE | 10MG/10ML (1MG/ML) | SOLUTION / INTRAVENOUS | AP | 2022-11-03 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A212627-001 | NEOSTIGMINE METHYLSULFATE | 5MG/10ML (0.5MG/ML) | SOLUTION / INTRAVENOUS | AP | 2022-11-03 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A212627-002 | NEOSTIGMINE METHYLSULFATE | 10MG/10ML (1MG/ML) | SOLUTION / INTRAVENOUS | AP | 2022-11-03 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A212627-001 | NEOSTIGMINE METHYLSULFATE | 5MG/10ML (0.5MG/ML) | SOLUTION / INTRAVENOUS | AP | 2022-11-03 | 8072bd15b7f6… | |
| 2024-05-31 18:47 UTC | 2024-05 | A212627-002 | NEOSTIGMINE METHYLSULFATE | 10MG/10ML (1MG/ML) | SOLUTION / INTRAVENOUS | AP | 2022-11-03 | 8072bd15b7f6… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A212627-001 | NEOSTIGMINE METHYLSULFATE | 5MG/10ML (0.5MG/ML) | SOLUTION / INTRAVENOUS | AP | 2022-11-03 | 6a51e52b5d6a… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A212627-002 | NEOSTIGMINE METHYLSULFATE | 10MG/10ML (1MG/ML) | SOLUTION / INTRAVENOUS | AP | 2022-11-03 | 6a51e52b5d6a… | |
| 2024-02-18 07:12 UTC | 2024-02 | A212627-001 | NEOSTIGMINE METHYLSULFATE | 5MG/10ML (0.5MG/ML) | SOLUTION / INTRAVENOUS | AP | 2022-11-03 | 1c564ffb4f44… | |
| 2024-02-18 07:12 UTC | 2024-02 | A212627-002 | NEOSTIGMINE METHYLSULFATE | 10MG/10ML (1MG/ML) | SOLUTION / INTRAVENOUS | AP | 2022-11-03 | 1c564ffb4f44… | |
| 2023-12-20 04:57 UTC | 2023-12 | A212627-001 | NEOSTIGMINE METHYLSULFATE | 5MG/10ML (0.5MG/ML) | SOLUTION / INTRAVENOUS | AP | 2022-11-03 | ea1830bbd6c7… | |
| 2023-12-20 04:57 UTC | 2023-12 | A212627-002 | NEOSTIGMINE METHYLSULFATE | 10MG/10ML (1MG/ML) | SOLUTION / INTRAVENOUS | AP | 2022-11-03 | ea1830bbd6c7… | |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A212627-001 | NEOSTIGMINE METHYLSULFATE | 5MG/10ML (0.5MG/ML) | SOLUTION / INTRAVENOUS | AP | 2022-11-03 | a72a2bbeb626… | |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A212627-002 | NEOSTIGMINE METHYLSULFATE | 10MG/10ML (1MG/ML) | SOLUTION / INTRAVENOUS | AP | 2022-11-03 | a72a2bbeb626… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A212627-001 | AP | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A212627-002 | AP | 1 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | A212627-001 | AP | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A212627-002 | AP | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A212627-001 | AP | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A212627-002 | AP | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A212627-001 | AP | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A212627-002 | AP | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A212627-001 | AP | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A212627-002 | AP | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A212627-001 | AP | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A212627-002 | AP | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A212627-001 | AP | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A212627-002 | AP | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A212627-001 | AP | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A212627-002 | AP | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A212627-001 | AP | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A212627-002 | AP | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A212627-001 | AP | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A212627-002 | AP | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A212627-001 | AP | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A212627-002 | AP | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A212627-001 | AP | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A212627-002 | AP | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A212627-001 | AP | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A212627-002 | AP | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A212627-001 | AP | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A212627-002 | AP | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A212627-001 | AP | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A212627-002 | AP | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A212627-001 | AP | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | A212627-002 | AP | 1 | 8072bd15b7f6… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A212627-001 | AP | 1 | 6a51e52b5d6a… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A212627-002 | AP | 1 | 6a51e52b5d6a… |
| 2024-02-18 07:12 UTC | 2024-02 | A212627-001 | AP | 1 | 1c564ffb4f44… |
| 2024-02-18 07:12 UTC | 2024-02 | A212627-002 | AP | 1 | 1c564ffb4f44… |
| 2023-12-20 04:57 UTC | 2023-12 | A212627-001 | AP | 1 | ea1830bbd6c7… |
| 2023-12-20 04:57 UTC | 2023-12 | A212627-002 | AP | 1 | ea1830bbd6c7… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A212627-001 | AP | 1 | a72a2bbeb626… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A212627-002 | AP | 1 | a72a2bbeb626… |
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.
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.