Application 211011
- Type
- ANDA
- Sponsor
- INGENUS PHARMS LLC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | CARMUSTINE | CARMUSTINE | INJECTABLE;INJECTION | 100MG/VIAL | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A211011-001 | CARMUSTINE | CARMUSTINE | 100MG/VIAL | INJECTABLE / INJECTION | 2022-06-21 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A211011-001 | CARMUSTINE | 100MG/VIAL | INJECTABLE / INJECTION | 2022-06-21 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A211011-001 | CARMUSTINE | 100MG/VIAL | INJECTABLE / INJECTION | 2022-06-21 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A211011-001 | CARMUSTINE | 100MG/VIAL | INJECTABLE / INJECTION | 2022-06-21 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A211011-001 | CARMUSTINE | 100MG/VIAL | INJECTABLE / INJECTION | 2022-06-21 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A211011-001 | CARMUSTINE | 100MG/VIAL | INJECTABLE / INJECTION | 2022-06-21 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A211011-001 | CARMUSTINE | 100MG/VIAL | INJECTABLE / INJECTION | 2022-06-21 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A211011-001 | CARMUSTINE | 100MG/VIAL | INJECTABLE / INJECTION | 2022-06-21 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A211011-001 | CARMUSTINE | 100MG/VIAL | INJECTABLE / INJECTION | 2022-06-21 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A211011-001 | CARMUSTINE | 100MG/VIAL | INJECTABLE / INJECTION | 2022-06-21 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A211011-001 | CARMUSTINE | 100MG/VIAL | INJECTABLE / INJECTION | 2022-06-21 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A211011-001 | CARMUSTINE | 100MG/VIAL | INJECTABLE / INJECTION | 2022-06-21 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A211011-001 | CARMUSTINE | 100MG/VIAL | INJECTABLE / INJECTION | 2022-06-21 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A211011-001 | CARMUSTINE | 100MG/VIAL | INJECTABLE / INJECTION | 2022-06-21 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A211011-001 | CARMUSTINE | 100MG/VIAL | INJECTABLE / INJECTION | 2022-06-21 | 8072bd15b7f6… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A211011-001 | CARMUSTINE | 100MG/VIAL | INJECTABLE / INJECTION | 2022-06-21 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A211011-001 | CARMUSTINE | 100MG/VIAL | INJECTABLE / INJECTION | AP | 2022-06-21 | 1c564ffb4f44… | |
| 2023-12-20 04:57 UTC | 2023-12 | A211011-001 | CARMUSTINE | 100MG/VIAL | INJECTABLE / INJECTION | AP | 2022-06-21 | ea1830bbd6c7… | |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A211011-001 | CARMUSTINE | 100MG/VIAL | INJECTABLE / INJECTION | AP | 2022-06-21 | a72a2bbeb626… | |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A211011-001 | CARMUSTINE | 100MG/VIAL | INJECTABLE / INJECTION | AP | 2022-06-21 | 9b2671bbb829… | |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A211011-001 | CARMUSTINE | 100MG/VIAL | INJECTABLE / INJECTION | AP | 2022-06-21 | a67488948f0b… | |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A211011-001 | CARMUSTINE | 100MG/VIAL | INJECTABLE / INJECTION | AP | 2022-06-21 | 3f0d92c62455… | |
| 2023-05-13 08:27 UTC | 2023-05 | A211011-001 | CARMUSTINE | 100MG/VIAL | INJECTABLE / INJECTION | AP | 2022-06-21 | 053a50430f4f… | |
| 2023-01-26 05:58 UTC | 2023-01 | A211011-001 | CARMUSTINE | 100MG/VIAL | INJECTABLE / INJECTION | AP | 2022-06-21 | 3bdfa0b2c4d7… | |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A211011-001 | CARMUSTINE | 100MG/VIAL | INJECTABLE / INJECTION | AP | 2022-06-21 | 3a93d1ddd44b… | |
| 2022-10-28 04:53 UTC | 2022-10 | A211011-001 | CARMUSTINE | 100MG/VIAL | INJECTABLE / INJECTION | AP | 2022-06-21 | f41ea6bd6efb… | |
| 2022-09-29 23:25 UTC | 2022-09 | A211011-001 | CARMUSTINE | 100MG/VIAL | INJECTABLE / INJECTION | AP | 2022-06-21 | e64feba35796… | |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A211011-001 | CARMUSTINE | 100MG/VIAL | INJECTABLE / INJECTION | AP | 2022-06-21 | cb3db0bc1861… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A211011-001 | CARMUSTINE | 100MG/VIAL | INJECTABLE / INJECTION | 2022-06-21 | a50c72e98297… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2024-02-18 07:12 UTC | 2024-02 | A211011-001 | AP | 1 | 1c564ffb4f44… |
| 2023-12-20 04:57 UTC | 2023-12 | A211011-001 | AP | 1 | ea1830bbd6c7… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A211011-001 | AP | 1 | a72a2bbeb626… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A211011-001 | AP | 1 | 9b2671bbb829… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A211011-001 | AP | 1 | a67488948f0b… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A211011-001 | AP | 1 | 3f0d92c62455… |
| 2023-05-13 08:27 UTC | 2023-05 | A211011-001 | AP | 1 | 053a50430f4f… |
| 2023-01-26 05:58 UTC | 2023-01 | A211011-001 | AP | 1 | 3bdfa0b2c4d7… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A211011-001 | AP | 1 | 3a93d1ddd44b… |
| 2022-10-28 04:53 UTC | 2022-10 | A211011-001 | AP | 1 | f41ea6bd6efb… |
| 2022-09-29 23:25 UTC | 2022-09 | A211011-001 | AP | 1 | e64feba35796… |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A211011-001 | AP | 1 | cb3db0bc1861… |
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 |
|---|---|---|---|---|---|---|
| CARMUSTINE | CARMUSTINE | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | b9b47082-32ee-4abb-a7b2-52292894d3f8 | 2026-04-09 | Boxed warning, Warnings, Adverse reactions | CARMUSTINE CARMUSTINE |
| carmustine | CARMUSTINE | Zydus Pharmaceuticals USA Inc. | 0bdd91e1-fd94-4ce8-9c99-1b0fa6fe8ae4 | 2025-11-21 | Boxed warning, Warnings, Adverse reactions | carmustine CARMUSTINE |
| Carmustine | CARMUSTINE | Navinta LLC | 06a0322b-eb28-44e2-9925-88bebd8fa91b | 2025-11-18 | Boxed warning, Warnings, Adverse reactions | Carmustine CARMUSTINE |
| Carmustine | CARMUSTINE | KVK-Tech, Inc. | 11c3fad8-65ef-39a7-e063-6294a90a73e1 | 2025-11-14 | Boxed warning, Warnings, Adverse reactions | Carmustine CARMUSTINE |
| carmustine | CARMUSTINE | Dr. Reddy's Laboratories Inc. | 7653a069-9cde-9ebf-5ccf-670f1a3f82b3 | 2025-06-01 | Boxed warning, Warnings, Adverse reactions | carmustine CARMUSTINE |
| Carmustine | CARMUSTINE | Meitheal Pharmaceuticals Inc. | 37a16d53-6a0d-4d24-a5f9-e8824b244b48 | 2025-05-29 | Boxed warning, Warnings, Adverse reactions | Carmustine CARMUSTINE |
| CARMUSTINE | CARMUSTINE | Sandoz Inc. | 82613f4f-05d1-4410-b288-15b6ad0fd069 | 2025-02-26 | Boxed warning, Warnings, Adverse reactions | CARMUSTINE CARMUSTINE |
| CARMUSTINE | CARMUSTINE | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | e15140cd-aae9-43d6-aa6a-4e819238be36 | 2025-01-02 | Boxed warning, Warnings, Adverse reactions | CARMUSTINE CARMUSTINE |
| Gliadel | CARMUSTINE | Azurity Pharmaceuticals, Inc. | 38962a55-a514-4c48-bea5-f99a8da4beec | 2024-12-05 | Warnings, Adverse reactions | CARMUSTINE |
| carmustine | CARMUSTINE | Dr. Reddy's Laboratories Inc. | b946c396-34fc-1845-1944-f16028a8447d | 2024-11-01 | Boxed warning, Warnings, Adverse reactions | carmustine CARMUSTINE |
| Carmustine | CARMUSTINE | Novadoz Pharmaceuticals LLC | e6e28c8c-f793-41f3-aaeb-7bf412660288 | 2023-11-15 | Boxed warning, Warnings, Adverse reactions | Carmustine CARMUSTINE |
| Carmustine | CARMUSTINE | Alembic Pharmaceuticals Limited | 6e0cfe79-6998-45b2-bceb-f8848624be5a | 2023-11-09 | Boxed warning, Warnings, Adverse reactions | Carmustine CARMUSTINE |
| Carmustine | CARMUSTINE | Alembic Pharmaceuticals Inc. | cd2bd05c-c56a-46d2-b698-e085e289de95 | 2023-11-03 | Boxed warning, Warnings, Adverse reactions | Carmustine CARMUSTINE |
| carmustine | CARMUSTINE | Amneal Pharmaceuticals LLC | 2df937ad-a458-4030-bb7b-4468baa3685e | 2023-06-03 | Boxed warning, Warnings, Adverse reactions | carmustine CARMUSTINE |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 50742-492 | CARMUSTINE | carmustine | Ingenus Pharmaceuticals, LLC | ANDA | Current |
| 50742-492 | CARMUSTINE | carmustine | Ingenus Pharmaceuticals, LLC | ANDA | Current |
| 70860-223 | Carmustine | carmustine | Athenex Pharmaceutical Division, LLC. | ANDA | Current |