Application 208419
- Type
- NDA
- Sponsor
- ACTAVIS LLC AN INDIRECT WHOLLY OWNED SUB OF TEVA P
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | PEMETREXED | PEMETREXED | INJECTABLE;INJECTION | 100MG/4ML | No | No |
| 002 | PEMETREXED | PEMETREXED | INJECTABLE;INJECTION | 500MG/20ML | No | No |
| 003 | PEMETREXED | PEMETREXED | INJECTABLE;INJECTION | 1G/40ML | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N208419-001 | PEMETREXED | PEMETREXED | 100MG/4ML (25MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2020-08-21 | |
| N208419-002 | PEMETREXED | PEMETREXED | 500MG/20ML (25MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2020-08-21 | |
| N208419-003 | PEMETREXED | PEMETREXED | 1GM/40ML (25MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2020-08-21 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | N208419-001 | PEMETREXED | 100MG/4ML (25MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2020-08-21 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N208419-002 | PEMETREXED | 500MG/20ML (25MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2020-08-21 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N208419-003 | PEMETREXED | 1GM/40ML (25MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2020-08-21 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | N208419-001 | PEMETREXED | 100MG/4ML (25MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2020-08-21 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N208419-002 | PEMETREXED | 500MG/20ML (25MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2020-08-21 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N208419-003 | PEMETREXED | 1GM/40ML (25MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2020-08-21 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N208419-001 | PEMETREXED | 100MG/4ML (25MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2020-08-21 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N208419-002 | PEMETREXED | 500MG/20ML (25MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2020-08-21 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N208419-003 | PEMETREXED | 1GM/40ML (25MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2020-08-21 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N208419-001 | PEMETREXED | 100MG/4ML (25MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2020-08-21 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N208419-002 | PEMETREXED | 500MG/20ML (25MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2020-08-21 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N208419-003 | PEMETREXED | 1GM/40ML (25MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2020-08-21 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N208419-001 | PEMETREXED | 100MG/4ML (25MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2020-08-21 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N208419-002 | PEMETREXED | 500MG/20ML (25MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2020-08-21 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N208419-003 | PEMETREXED | 1GM/40ML (25MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2020-08-21 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N208419-001 | PEMETREXED | 100MG/4ML (25MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2020-08-21 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N208419-002 | PEMETREXED | 500MG/20ML (25MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2020-08-21 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N208419-003 | PEMETREXED | 1GM/40ML (25MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2020-08-21 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N208419-001 | PEMETREXED | 100MG/4ML (25MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2020-08-21 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N208419-002 | PEMETREXED | 500MG/20ML (25MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2020-08-21 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N208419-003 | PEMETREXED | 1GM/40ML (25MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2020-08-21 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N208419-001 | PEMETREXED | 100MG/4ML (25MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2020-08-21 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N208419-002 | PEMETREXED | 500MG/20ML (25MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2020-08-21 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N208419-003 | PEMETREXED | 1GM/40ML (25MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2020-08-21 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N208419-001 | PEMETREXED | 100MG/4ML (25MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2020-08-21 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N208419-002 | PEMETREXED | 500MG/20ML (25MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2020-08-21 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N208419-003 | PEMETREXED | 1GM/40ML (25MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2020-08-21 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N208419-001 | PEMETREXED | 100MG/4ML (25MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2020-08-21 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N208419-002 | PEMETREXED | 500MG/20ML (25MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2020-08-21 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N208419-003 | PEMETREXED | 1GM/40ML (25MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2020-08-21 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | N208419-001 | PEMETREXED | 100MG/4ML (25MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2020-08-21 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N208419-002 | PEMETREXED | 500MG/20ML (25MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2020-08-21 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N208419-003 | PEMETREXED | 1GM/40ML (25MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2020-08-21 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N208419-001 | PEMETREXED | 100MG/4ML (25MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2020-08-21 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N208419-002 | PEMETREXED | 500MG/20ML (25MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2020-08-21 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N208419-003 | PEMETREXED | 1GM/40ML (25MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2020-08-21 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N208419-001 | PEMETREXED | 100MG/4ML (25MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2020-08-21 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N208419-002 | PEMETREXED | 500MG/20ML (25MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2020-08-21 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N208419-003 | PEMETREXED | 1GM/40ML (25MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2020-08-21 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N208419-001 | PEMETREXED | 100MG/4ML (25MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2020-08-21 | 1e350fbaab3a… |
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 |
|---|---|---|---|---|---|---|
| Pemetrexed | PEMETREXED | Teva Pharmaceuticals, Inc. | 8b660f68-b770-4e0a-b2f9-25e663deecc3 | 2022-12-01 | Warnings, Adverse reactions | 208419 NDA208419 0480-4515 0480-4514 0480-4516 |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0480-4514 | Pemetrexed | Pemetrexed | Teva Pharmaceuticals, Inc. | NDA | Current |
| 0480-4514 | Pemetrexed | Pemetrexed | Teva Pharmaceuticals, Inc. | NDA | Current |
| 0480-4515 | Pemetrexed | Pemetrexed | Teva Pharmaceuticals, Inc. | NDA | Current |
| 0480-4515 | Pemetrexed | Pemetrexed | Teva Pharmaceuticals, Inc. | NDA | Current |
| 0480-4516 | Pemetrexed | Pemetrexed | Teva Pharmaceuticals, Inc. | NDA | Current |
| 0480-4516 | Pemetrexed | Pemetrexed | Teva Pharmaceuticals, Inc. | NDA | Current |