Application 076959
- Type
- ANDA
- Sponsor
- SANDOZ
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | CARBOPLATIN | CARBOPLATIN | INJECTABLE;INJECTION | 50MG/VIAL | No | No |
| 002 | CARBOPLATIN | CARBOPLATIN | INJECTABLE;INJECTION | 150MG/VIAL | No | No |
| 003 | CARBOPLATIN | CARBOPLATIN | INJECTABLE;INJECTION | 450MG/VIAL | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A076959-001 | CARBOPLATIN | CARBOPLATIN | 50MG/VIAL | INJECTABLE / INJECTION | 2005-03-18 | ||
| A076959-002 | CARBOPLATIN | CARBOPLATIN | 150MG/VIAL | INJECTABLE / INJECTION | 2005-03-18 | ||
| A076959-003 | CARBOPLATIN | CARBOPLATIN | 450MG/VIAL | INJECTABLE / INJECTION | 2005-03-18 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A076959-002 | CARBOPLATIN | 150MG/VIAL | INJECTABLE / INJECTION | 2005-03-18 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A076959-003 | CARBOPLATIN | 450MG/VIAL | INJECTABLE / INJECTION | 2005-03-18 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A076959-001 | CARBOPLATIN | 50MG/VIAL | INJECTABLE / INJECTION | 2005-03-18 | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A076959-002 | CARBOPLATIN | 150MG/VIAL | INJECTABLE / INJECTION | 2005-03-18 | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A076959-003 | CARBOPLATIN | 450MG/VIAL | INJECTABLE / INJECTION | 2005-03-18 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A076959-001 | CARBOPLATIN | 50MG/VIAL | INJECTABLE / INJECTION | 2005-03-18 | 1e350fbaab3a… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A076959-002 | CARBOPLATIN | 150MG/VIAL | INJECTABLE / INJECTION | 2005-03-18 | 1e350fbaab3a… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A076959-003 | CARBOPLATIN | 450MG/VIAL | INJECTABLE / INJECTION | 2005-03-18 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A076959-001 | CARBOPLATIN | 50MG/VIAL | INJECTABLE / INJECTION | 2005-03-18 | 8072bd15b7f6… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A076959-002 | CARBOPLATIN | 150MG/VIAL | INJECTABLE / INJECTION | 2005-03-18 | 8072bd15b7f6… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A076959-003 | CARBOPLATIN | 450MG/VIAL | INJECTABLE / INJECTION | 2005-03-18 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A076959-001 | CARBOPLATIN | 50MG/VIAL | INJECTABLE / INJECTION | 2005-03-18 | 5c6f7cd8ea54… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A076959-002 | CARBOPLATIN | 150MG/VIAL | INJECTABLE / INJECTION | 2005-03-18 | 5c6f7cd8ea54… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A076959-003 | CARBOPLATIN | 450MG/VIAL | INJECTABLE / INJECTION | 2005-03-18 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A076959-001 | CARBOPLATIN | 50MG/VIAL | INJECTABLE / INJECTION | 2005-03-18 | 5d02ea3f76ae… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A076959-002 | CARBOPLATIN | 150MG/VIAL | INJECTABLE / INJECTION | 2005-03-18 | 5d02ea3f76ae… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A076959-003 | CARBOPLATIN | 450MG/VIAL | INJECTABLE / INJECTION | 2005-03-18 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A076959-001 | CARBOPLATIN | 50MG/VIAL | INJECTABLE / INJECTION | 2005-03-18 | 4b0b4de00fa7… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A076959-002 | CARBOPLATIN | 150MG/VIAL | INJECTABLE / INJECTION | 2005-03-18 | 4b0b4de00fa7… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A076959-003 | CARBOPLATIN | 450MG/VIAL | INJECTABLE / INJECTION | 2005-03-18 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A076959-001 | CARBOPLATIN | 50MG/VIAL | INJECTABLE / INJECTION | 2005-03-18 | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A076959-002 | CARBOPLATIN | 150MG/VIAL | INJECTABLE / INJECTION | 2005-03-18 | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A076959-003 | CARBOPLATIN | 450MG/VIAL | INJECTABLE / INJECTION | 2005-03-18 | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A076959-001 | CARBOPLATIN | 50MG/VIAL | INJECTABLE / INJECTION | 2005-03-18 | bb7c543d1eb4… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A076959-002 | CARBOPLATIN | 150MG/VIAL | INJECTABLE / INJECTION | 2005-03-18 | bb7c543d1eb4… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A076959-003 | CARBOPLATIN | 450MG/VIAL | INJECTABLE / INJECTION | 2005-03-18 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A076959-001 | CARBOPLATIN | 50MG/VIAL | INJECTABLE / INJECTION | 2005-03-18 | 782e0a99824c… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A076959-002 | CARBOPLATIN | 150MG/VIAL | INJECTABLE / INJECTION | 2005-03-18 | 782e0a99824c… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A076959-003 | CARBOPLATIN | 450MG/VIAL | INJECTABLE / INJECTION | 2005-03-18 | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A076959-001 | CARBOPLATIN | 50MG/VIAL | INJECTABLE / INJECTION | 2005-03-18 | 87673890dc5c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A076959-002 | CARBOPLATIN | 150MG/VIAL | INJECTABLE / INJECTION | 2005-03-18 | 87673890dc5c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A076959-003 | CARBOPLATIN | 450MG/VIAL | INJECTABLE / INJECTION | 2005-03-18 | 87673890dc5c… | ||
| 2021-03-12 10:30 UTC | 2021-03 | A076959-001 | CARBOPLATIN | 50MG/VIAL | INJECTABLE / INJECTION | 2005-03-18 | 5aa47cf7b7d7… | ||
| 2021-03-12 10:30 UTC | 2021-03 | A076959-002 | CARBOPLATIN | 150MG/VIAL | INJECTABLE / INJECTION | 2005-03-18 | 5aa47cf7b7d7… | ||
| 2021-03-12 10:30 UTC | 2021-03 | A076959-003 | CARBOPLATIN | 450MG/VIAL | INJECTABLE / INJECTION | 2005-03-18 | 5aa47cf7b7d7… | ||
| 2020-12-22 03:56 UTC | 2020-12 | A076959-001 | CARBOPLATIN | 50MG/VIAL | INJECTABLE / INJECTION | 2005-03-18 | 8869cabd3fbd… | ||
| 2020-12-22 03:56 UTC | 2020-12 | A076959-002 | CARBOPLATIN | 150MG/VIAL | INJECTABLE / INJECTION | 2005-03-18 | 8869cabd3fbd… | ||
| 2020-12-22 03:56 UTC | 2020-12 | A076959-003 | CARBOPLATIN | 450MG/VIAL | INJECTABLE / INJECTION | 2005-03-18 | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | A076959-001 | CARBOPLATIN | 50MG/VIAL | INJECTABLE / INJECTION | 2005-03-18 | c0c555d07b60… | ||
| 2020-11-12 02:37 UTC | 2020-11 | A076959-002 | CARBOPLATIN | 150MG/VIAL | INJECTABLE / INJECTION | 2005-03-18 | c0c555d07b60… |
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 |
|---|---|---|---|---|---|---|
| CARBOPLATIN | CARBOPLATIN | Natco Pharma USA LLC | 4c89cedc-e48b-445c-ad05-54dbe60e4fb0 | 2026-07-21 | Boxed warning, Warnings, Adverse reactions | CARBOPLATIN CARBOPLATIN |
| CARBOPLATIN | CARBOPLATIN | BPI Labs LLC | 5484d2f0-0cc2-4bba-8f26-c7f6539a9606 | 2025-12-26 | Boxed warning, Warnings, Adverse reactions | CARBOPLATIN CARBOPLATIN |
| KYXATA | CARBOPLATIN | Avyxa Pharma, LLC | f91c48da-68d1-4aa7-89b8-d84a3e8b629b | 2025-09-02 | Boxed warning, Warnings, Adverse reactions | CARBOPLATIN |
| Carboplatin | CARBOPLATIN | Accord Healthcare, Inc. | 48aa7ef3-9f44-2a08-e054-00144ff88e88 | 2025-05-23 | Boxed warning, Warnings, Adverse reactions | Carboplatin CARBOPLATIN |
| CARBOPLATIN | CARBOPLATIN | Eugia US LLC | 5abfcb87-bb02-4384-9c9d-7d0e3e809311 | 2025-01-30 | Boxed warning, Warnings, Adverse reactions | CARBOPLATIN CARBOPLATIN |
| CARBOPLATIN | CARBOPLATIN | Eugia US LLC | f5fe9a20-47a5-45b9-ab06-c6158d9b6aca | 2025-01-10 | Boxed warning, Warnings, Adverse reactions | CARBOPLATIN CARBOPLATIN |
| CARBOPLATIN | CARBOPLATIN | Teyro Labs Private Limited | f64a0cbe-7fe3-407e-8933-21c30e1a1ebc | 2025-01-08 | Boxed warning, Warnings, Adverse reactions | CARBOPLATIN CARBOPLATIN |
| Carboplatin | CARBOPLATIN | Hospira, Inc. | 47677091-fd20-49af-933c-c9dd2be21de9 | 2024-08-21 | Boxed warning, Warnings, Adverse reactions | Carboplatin CARBOPLATIN |
| Carboplatin | CARBOPLATIN | Hospira, Inc. | c3ae9880-44bb-4f4e-93d8-8a5e21708a30 | 2024-06-20 | Boxed warning, Warnings, Adverse reactions | Carboplatin CARBOPLATIN |
| CARBOPLATIN | CARBOPLATIN | Apotex Corp. | 1c275825-0275-4c73-b650-e4c1519f13b8 | 2024-01-07 | Boxed warning, Warnings, Adverse reactions | CARBOPLATIN CARBOPLATIN |
| CARBOPLATIN | CARBOPLATIN | Gland Pharma Limited | 9eb057eb-29ce-40d2-9ac8-ed107f25f5ab | 2023-11-09 | Boxed warning, Warnings, Adverse reactions | CARBOPLATIN CARBOPLATIN |
| Carboplatin | CARBOPLATIN | Teva Parenteral Medicines, Inc. | e176b6ef-2ff6-498b-a9d8-7a634d147f37 | 2022-08-30 | Boxed warning, Warnings, Adverse reactions | Carboplatin CARBOPLATIN |
| Carboplatin | CARBOPLATIN | Fresenius Kabi USA, LLC | b4fa7aac-c9d2-4af4-a281-3e6cfc502ff6 | 2021-07-07 | Boxed warning, Warnings, Adverse reactions | Carboplatin CARBOPLATIN |
| CARBOplatin | CARBOPLATIN | Teva Parenteral Medicines, Inc. | f330f5a2-2cad-402f-bcbb-26245a753276 | 2016-01-31 | Boxed warning, Warnings, Adverse reactions | CARBOplatin CARBOPLATIN |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.