Application 214408
- Type
- NDA
- Sponsor
- ACCORD HLTHCARE INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | PEMETREXED | PEMETREXED | SOLUTION;INTRAVENOUS | 100MG/4ML (25MG/ML), | No | No |
| 002 | PEMETREXED | PEMETREXED | SOLUTION;INTRAVENOUS | 500MG/20ML (25MG/ML) | No | No |
| 003 | PEMETREXED | PEMETREXED | SOLUTION;INTRAVENOUS | 850MG/34ML (25MG/ML) | No | No |
| 004 | PEMETREXED | PEMETREXED | SOLUTION;INTRAVENOUS | 1000MG/40ML (25MG/ML). | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N214408-001 | PEMETREXED DISODIUM | PEMETREXED DISODIUM | EQ 100MG BASE/4ML (EQ 25MG BASE/ML) | SOLUTION / INTRAVENOUS | RLD | 2022-07-19 | |
| N214408-002 | PEMETREXED DISODIUM | PEMETREXED DISODIUM | EQ 500MG BASE/20ML (EQ 25MG BASE/ML) | SOLUTION / INTRAVENOUS | RLD | 2022-07-19 | |
| N214408-003 | PEMETREXED DISODIUM | PEMETREXED DISODIUM | EQ 850MG BASE/34ML (EQ 25MG BASE/ML) | SOLUTION / INTRAVENOUS | RLD | 2022-07-19 | |
| N214408-004 | PEMETREXED DISODIUM | PEMETREXED DISODIUM | EQ 1GM BASE/40ML (EQ 25MG BASE/ML) | SOLUTION / INTRAVENOUS | RLD | 2022-07-19 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | N214408-001 | PEMETREXED DISODIUM | EQ 100MG BASE/4ML (EQ 25MG BASE/ML) | SOLUTION / INTRAVENOUS | RLD | 2022-07-19 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N214408-002 | PEMETREXED DISODIUM | EQ 500MG BASE/20ML (EQ 25MG BASE/ML) | SOLUTION / INTRAVENOUS | RLD | 2022-07-19 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N214408-003 | PEMETREXED DISODIUM | EQ 850MG BASE/34ML (EQ 25MG BASE/ML) | SOLUTION / INTRAVENOUS | RLD | 2022-07-19 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N214408-004 | PEMETREXED DISODIUM | EQ 1GM BASE/40ML (EQ 25MG BASE/ML) | SOLUTION / INTRAVENOUS | RLD | 2022-07-19 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | N214408-001 | PEMETREXED DISODIUM | EQ 100MG BASE/4ML (EQ 25MG BASE/ML) | SOLUTION / INTRAVENOUS | RLD | 2022-07-19 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N214408-002 | PEMETREXED DISODIUM | EQ 500MG BASE/20ML (EQ 25MG BASE/ML) | SOLUTION / INTRAVENOUS | RLD | 2022-07-19 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N214408-003 | PEMETREXED DISODIUM | EQ 850MG BASE/34ML (EQ 25MG BASE/ML) | SOLUTION / INTRAVENOUS | RLD | 2022-07-19 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N214408-004 | PEMETREXED DISODIUM | EQ 1GM BASE/40ML (EQ 25MG BASE/ML) | SOLUTION / INTRAVENOUS | RLD | 2022-07-19 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N214408-001 | PEMETREXED DISODIUM | EQ 100MG BASE/4ML (EQ 25MG BASE/ML) | SOLUTION / INTRAVENOUS | RLD | 2022-07-19 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N214408-002 | PEMETREXED DISODIUM | EQ 500MG BASE/20ML (EQ 25MG BASE/ML) | SOLUTION / INTRAVENOUS | RLD | 2022-07-19 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N214408-003 | PEMETREXED DISODIUM | EQ 850MG BASE/34ML (EQ 25MG BASE/ML) | SOLUTION / INTRAVENOUS | RLD | 2022-07-19 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N214408-004 | PEMETREXED DISODIUM | EQ 1GM BASE/40ML (EQ 25MG BASE/ML) | SOLUTION / INTRAVENOUS | RLD | 2022-07-19 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N214408-001 | PEMETREXED DISODIUM | EQ 100MG BASE/4ML (EQ 25MG BASE/ML) | SOLUTION / INTRAVENOUS | RLD | 2022-07-19 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N214408-002 | PEMETREXED DISODIUM | EQ 500MG BASE/20ML (EQ 25MG BASE/ML) | SOLUTION / INTRAVENOUS | RLD | 2022-07-19 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N214408-003 | PEMETREXED DISODIUM | EQ 850MG BASE/34ML (EQ 25MG BASE/ML) | SOLUTION / INTRAVENOUS | RLD | 2022-07-19 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N214408-004 | PEMETREXED DISODIUM | EQ 1GM BASE/40ML (EQ 25MG BASE/ML) | SOLUTION / INTRAVENOUS | RLD | 2022-07-19 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N214408-001 | PEMETREXED DISODIUM | EQ 100MG BASE/4ML (EQ 25MG BASE/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2022-07-19 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N214408-002 | PEMETREXED DISODIUM | EQ 500MG BASE/20ML (EQ 25MG BASE/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2022-07-19 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N214408-003 | PEMETREXED DISODIUM | EQ 850MG BASE/34ML (EQ 25MG BASE/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2022-07-19 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N214408-004 | PEMETREXED DISODIUM | EQ 1GM BASE/40ML (EQ 25MG BASE/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2022-07-19 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N214408-001 | PEMETREXED DISODIUM | EQ 100MG BASE/4ML (EQ 25MG BASE/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2022-07-19 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N214408-002 | PEMETREXED DISODIUM | EQ 500MG BASE/20ML (EQ 25MG BASE/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2022-07-19 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N214408-003 | PEMETREXED DISODIUM | EQ 850MG BASE/34ML (EQ 25MG BASE/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2022-07-19 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N214408-004 | PEMETREXED DISODIUM | EQ 1GM BASE/40ML (EQ 25MG BASE/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2022-07-19 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N214408-001 | PEMETREXED DISODIUM | EQ 100MG BASE/4ML (EQ 25MG BASE/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2022-07-19 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N214408-002 | PEMETREXED DISODIUM | EQ 500MG BASE/20ML (EQ 25MG BASE/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2022-07-19 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N214408-003 | PEMETREXED DISODIUM | EQ 850MG BASE/34ML (EQ 25MG BASE/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2022-07-19 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N214408-004 | PEMETREXED DISODIUM | EQ 1GM BASE/40ML (EQ 25MG BASE/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2022-07-19 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N214408-001 | PEMETREXED DISODIUM | EQ 100MG BASE/4ML (EQ 25MG BASE/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2022-07-19 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N214408-002 | PEMETREXED DISODIUM | EQ 500MG BASE/20ML (EQ 25MG BASE/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2022-07-19 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N214408-003 | PEMETREXED DISODIUM | EQ 850MG BASE/34ML (EQ 25MG BASE/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2022-07-19 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N214408-004 | PEMETREXED DISODIUM | EQ 1GM BASE/40ML (EQ 25MG BASE/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2022-07-19 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N214408-001 | PEMETREXED DISODIUM | EQ 100MG BASE/4ML (EQ 25MG BASE/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2022-07-19 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N214408-002 | PEMETREXED DISODIUM | EQ 500MG BASE/20ML (EQ 25MG BASE/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2022-07-19 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N214408-003 | PEMETREXED DISODIUM | EQ 850MG BASE/34ML (EQ 25MG BASE/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2022-07-19 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N214408-004 | PEMETREXED DISODIUM | EQ 1GM BASE/40ML (EQ 25MG BASE/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2022-07-19 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N214408-001 | PEMETREXED DISODIUM | EQ 100MG BASE/4ML (EQ 25MG BASE/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2022-07-19 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N214408-002 | PEMETREXED DISODIUM | EQ 500MG BASE/20ML (EQ 25MG BASE/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2022-07-19 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N214408-003 | PEMETREXED DISODIUM | EQ 850MG BASE/34ML (EQ 25MG BASE/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2022-07-19 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N214408-004 | PEMETREXED DISODIUM | EQ 1GM BASE/40ML (EQ 25MG BASE/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2022-07-19 | d8e5a09893c0… |
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 |
|---|---|---|---|---|---|---|
| Pemfexy | PEMETREXED | Acacia Pharma, Ltd. | caef07ce-066b-4c48-98dc-974b05ebbbe0 | 2026-06-18 | Warnings, Adverse reactions | PEMETREXED |
| Pemfexy | PEMETREXED | Eagle Pharmaceuticals, Inc. | 2308f4e8-21c8-49c1-a5b8-deb8610bac6a | 2026-02-20 | Warnings, Adverse reactions | PEMETREXED |
| Pemetrexed | PEMETREXED | Solco Healthcare US, LLC | bd0ada98-3237-4465-8ba2-3a12c33116fb | 2025-12-31 | Warnings, Adverse reactions | Pemetrexed PEMETREXED |
| Pemetrexed | PEMETREXED DISODIUM | Sandoz Inc. | 7ac04ab7-7f8c-46ce-ab56-a7a08cd02ab3 | 2025-12-16 | Warnings, Adverse reactions | Pemetrexed |
| Pemetrexed | PEMETREXED DISODIUM | Meitheal Pharmaceuticals Inc. | e0d000a3-b9d2-4fa9-9591-f7acb077481d | 2025-11-17 | Warnings, Adverse reactions | Pemetrexed |
| PEMETREXED | PEMETREXED | Hospira, Inc. | 3ae68628-7ab0-4491-b3ae-6a8330b719c8 | 2025-10-08 | Warnings, Adverse reactions | PEMETREXED PEMETREXED |
| AXTLE | PEMETREXED | Avyxa Pharma, LLC | 9582c46c-d8b0-44b7-a2ee-9c86f5e9b7b1 | 2025-10-08 | Warnings, Adverse reactions | PEMETREXED |
| Pemetrexed | PEMETREXED DISODIUM | Fresenius Kabi USA, LLC | ae77f00f-d43b-4b75-afd5-a2a9cb7138da | 2025-08-31 | Warnings, Adverse reactions | Pemetrexed |
| Pemetrexed | PEMETREXED DISODIUM | Somerset Therapeutics LLC | 39219e4b-80a6-4d4f-96a3-1202e542d050 | 2025-05-10 | Warnings, Adverse reactions | Pemetrexed |
| Pemetrexed | PEMETREXED DISODIUM | Camber Pharmaceuticals, Inc. | 2ca1ce75-5284-4282-b76a-3700d203c714 | 2025-04-01 | Warnings, Adverse reactions | Pemetrexed |
| Pemetrexed | PEMETREXED DISODIUM | Shilpa Medicare Limited | fe432994-e61b-4a87-8c98-cc20b847d0fe | 2024-11-28 | Warnings, Adverse reactions | Pemetrexed |
| Pemetrexed | PEMETREXED DISODIUM | Sagent Pharmaceuticals | fa8f1f52-3f05-4ae8-bfec-7f0a029e6825 | 2024-09-30 | Warnings, Adverse reactions | Pemetrexed |
| Pemetrexed | PEMETREXED DISODIUM | NorthStar RxLLC | 64f4a9ed-26ff-4bc7-bef1-4faa98b35563 | 2024-09-10 | Warnings, Adverse reactions | Pemetrexed |
| PEMETREXED | PEMETREXED | Hospira, Inc. | 3e087418-69ff-47fa-93c2-f28699309433 | 2024-07-24 | Warnings, Adverse reactions | PEMETREXED PEMETREXED |
| PEMETREXED | PEMETREXED | Accord Healthcare Inc. | dfd19e67-54cb-c062-e053-2995a90a294a | 2024-07-18 | Warnings, Adverse reactions | PEMETREXED PEMETREXED |
| Pemetrexed | PEMETREXED DISODIUM | Meitheal Pharmaceuticals Inc. | 1ceacc3e-f555-489b-8b16-2baa58b2f5a5 | 2024-04-19 | Warnings, Adverse reactions | Pemetrexed |
| Pemetrexed | PEMETREXED DISODIUM | Meitheal Pharmaceuticals Inc. | 5fb3a2d5-b9ec-4044-abb9-3e0d848a448e | 2024-04-19 | Warnings, Adverse reactions | Pemetrexed |
| Pemetrexed | PEMETREXED DISODIUM | Waverley Pharma Inc | 95633c32-89a8-4275-94e7-939c9f2e6135 | 2023-12-30 | Warnings, Adverse reactions | Pemetrexed |
| Pemetrexed | PEMETREXED DISODIUM | BluePoint Laboratories | 4cc1574b-3d2f-489b-9ad3-55695bb97200 | 2023-10-10 | Warnings, Adverse reactions | Pemetrexed |
| Pemetrexed | PEMETREXED | BluePoint Laboratories | 495c6751-8d6f-4093-8108-9bed283fce03 | 2023-09-05 | Warnings, Adverse reactions | Pemetrexed PEMETREXED |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 16729-522 | Pemetrexed | Pemetrexed disodium | Accord Healthcare Inc. | NDA | Current |
| 16729-522 | Pemetrexed | Pemetrexed disodium | Accord Healthcare Inc. | NDA | Current |
| 68001-550 | Pemetrexed | Pemetrexed disodium | BluePoint Laboratories | NDA | Current |
| 68001-551 | Pemetrexed | Pemetrexed disodium | BluePoint Laboratories | NDA | Current |
| 68001-552 | Pemetrexed | Pemetrexed disodium | BluePoint Laboratories | NDA | Current |
| 68001-553 | Pemetrexed | Pemetrexed disodium | BluePoint Laboratories | NDA | Current |