Application 215179
- Type
- NDA
- Sponsor
- SHILPA
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | PEMETREXED | PEMETREXED DISODIUM | SOLUTION;INTRAVENOUS | EQ 100MG/10ML BASE (10MG/ML) | Yes | Yes |
| 002 | PEMETREXED | PEMETREXED DISODIUM | SOLUTION;INTRAVENOUS | EQ 500MG/50ML BASE (10MG/ML) | Yes | Yes |
| 003 | PEMETREXED | PEMETREXED DISODIUM | SOLUTION;INTRAVENOUS | EQ 1GM/100ML BASE (10MG/ML) | Yes | Yes |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N215179-001 | PEMETREXED | PEMETREXED DISODIUM | EQ 100MG/10ML BASE (10MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2023-05-22 | |
| N215179-002 | PEMETREXED | PEMETREXED DISODIUM | EQ 500MG/50ML BASE (10MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2023-05-22 | |
| N215179-003 | PEMETREXED | PEMETREXED DISODIUM | EQ 1GM/100ML BASE (10MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2023-05-22 |
Orange Book patents#
| Application-product | Patent | Expiration | Use code | Coverage / status | Submission date |
|---|---|---|---|---|---|
| N215179-001 | 11147817 | 2035-03-26 | Drug product | 2023-06-06 | |
| N215179-002 | 11147817 | 2035-03-26 | Drug product | 2023-06-06 | |
| N215179-003 | 11147817 | 2035-03-26 | Drug product | 2023-06-06 |
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 | N215179-001 | PEMETREXED | EQ 100MG/10ML BASE (10MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2023-05-22 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N215179-002 | PEMETREXED | EQ 500MG/50ML BASE (10MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2023-05-22 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N215179-003 | PEMETREXED | EQ 1GM/100ML BASE (10MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2023-05-22 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | N215179-001 | PEMETREXED | EQ 100MG/10ML BASE (10MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2023-05-22 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N215179-002 | PEMETREXED | EQ 500MG/50ML BASE (10MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2023-05-22 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N215179-003 | PEMETREXED | EQ 1GM/100ML BASE (10MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2023-05-22 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N215179-001 | PEMETREXED | EQ 100MG/10ML BASE (10MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2023-05-22 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N215179-002 | PEMETREXED | EQ 500MG/50ML BASE (10MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2023-05-22 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N215179-003 | PEMETREXED | EQ 1GM/100ML BASE (10MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2023-05-22 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N215179-001 | PEMETREXED | EQ 100MG/10ML BASE (10MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2023-05-22 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N215179-002 | PEMETREXED | EQ 500MG/50ML BASE (10MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2023-05-22 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N215179-003 | PEMETREXED | EQ 1GM/100ML BASE (10MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2023-05-22 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N215179-001 | PEMETREXED | EQ 100MG/10ML BASE (10MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2023-05-22 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N215179-002 | PEMETREXED | EQ 500MG/50ML BASE (10MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2023-05-22 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N215179-003 | PEMETREXED | EQ 1GM/100ML BASE (10MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2023-05-22 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N215179-001 | PEMETREXED | EQ 100MG/10ML BASE (10MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2023-05-22 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N215179-002 | PEMETREXED | EQ 500MG/50ML BASE (10MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2023-05-22 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N215179-003 | PEMETREXED | EQ 1GM/100ML BASE (10MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2023-05-22 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N215179-001 | PEMETREXED | EQ 100MG/10ML BASE (10MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2023-05-22 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N215179-002 | PEMETREXED | EQ 500MG/50ML BASE (10MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2023-05-22 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N215179-003 | PEMETREXED | EQ 1GM/100ML BASE (10MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2023-05-22 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N215179-001 | PEMETREXED | EQ 100MG/10ML BASE (10MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2023-05-22 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N215179-002 | PEMETREXED | EQ 500MG/50ML BASE (10MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2023-05-22 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N215179-003 | PEMETREXED | EQ 1GM/100ML BASE (10MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2023-05-22 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N215179-001 | PEMETREXED | EQ 100MG/10ML BASE (10MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2023-05-22 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N215179-002 | PEMETREXED | EQ 500MG/50ML BASE (10MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2023-05-22 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N215179-003 | PEMETREXED | EQ 1GM/100ML BASE (10MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2023-05-22 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N215179-001 | PEMETREXED | EQ 100MG/10ML BASE (10MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2023-05-22 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N215179-002 | PEMETREXED | EQ 500MG/50ML BASE (10MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2023-05-22 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N215179-003 | PEMETREXED | EQ 1GM/100ML BASE (10MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2023-05-22 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | N215179-001 | PEMETREXED | EQ 100MG/10ML BASE (10MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2023-05-22 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N215179-002 | PEMETREXED | EQ 500MG/50ML BASE (10MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2023-05-22 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N215179-003 | PEMETREXED | EQ 1GM/100ML BASE (10MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2023-05-22 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N215179-001 | PEMETREXED | EQ 100MG/10ML BASE (10MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2023-05-22 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N215179-002 | PEMETREXED | EQ 500MG/50ML BASE (10MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2023-05-22 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N215179-003 | PEMETREXED | EQ 1GM/100ML BASE (10MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2023-05-22 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N215179-001 | PEMETREXED | EQ 100MG/10ML BASE (10MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2023-05-22 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N215179-002 | PEMETREXED | EQ 500MG/50ML BASE (10MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2023-05-22 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N215179-003 | PEMETREXED | EQ 1GM/100ML BASE (10MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2023-05-22 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N215179-001 | PEMETREXED | EQ 100MG/10ML BASE (10MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2023-05-22 | 1e350fbaab3a… |
Observed Orange Book patent history#
| Captured | Edition | Application-product | Patent | Expiration | Use code | Coverage / status | Submission date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | N215179-001 | 11147817 | 2035-03-26 | Drug product | 2023-06-06 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N215179-002 | 11147817 | 2035-03-26 | Drug product | 2023-06-06 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N215179-003 | 11147817 | 2035-03-26 | Drug product | 2023-06-06 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | N215179-001 | 11147817 | 2035-03-26 | Drug product | 2023-06-06 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N215179-002 | 11147817 | 2035-03-26 | Drug product | 2023-06-06 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N215179-003 | 11147817 | 2035-03-26 | Drug product | 2023-06-06 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N215179-001 | 11147817 | 2035-03-26 | Drug product | 2023-06-06 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N215179-002 | 11147817 | 2035-03-26 | Drug product | 2023-06-06 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N215179-003 | 11147817 | 2035-03-26 | Drug product | 2023-06-06 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N215179-001 | 11147817 | 2035-03-26 | Drug product | 2023-06-06 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N215179-002 | 11147817 | 2035-03-26 | Drug product | 2023-06-06 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N215179-003 | 11147817 | 2035-03-26 | Drug product | 2023-06-06 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N215179-001 | 11147817 | 2035-03-26 | Drug product | 2023-06-06 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N215179-002 | 11147817 | 2035-03-26 | Drug product | 2023-06-06 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N215179-003 | 11147817 | 2035-03-26 | Drug product | 2023-06-06 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N215179-001 | 11147817 | 2035-03-26 | Drug product | 2023-06-06 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N215179-002 | 11147817 | 2035-03-26 | Drug product | 2023-06-06 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N215179-003 | 11147817 | 2035-03-26 | Drug product | 2023-06-06 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N215179-001 | 11147817 | 2035-03-26 | Drug product | 2023-06-06 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N215179-002 | 11147817 | 2035-03-26 | Drug product | 2023-06-06 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N215179-003 | 11147817 | 2035-03-26 | Drug product | 2023-06-06 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N215179-001 | 11147817 | 2035-03-26 | Drug product | 2023-06-06 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N215179-002 | 11147817 | 2035-03-26 | Drug product | 2023-06-06 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N215179-003 | 11147817 | 2035-03-26 | Drug product | 2023-06-06 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N215179-001 | 11147817 | 2035-03-26 | Drug product | 2023-06-06 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N215179-002 | 11147817 | 2035-03-26 | Drug product | 2023-06-06 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N215179-003 | 11147817 | 2035-03-26 | Drug product | 2023-06-06 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N215179-001 | 11147817 | 2035-03-26 | Drug product | 2023-06-06 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N215179-002 | 11147817 | 2035-03-26 | Drug product | 2023-06-06 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N215179-003 | 11147817 | 2035-03-26 | Drug product | 2023-06-06 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | N215179-001 | 11147817 | 2035-03-26 | Drug product | 2023-06-06 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N215179-002 | 11147817 | 2035-03-26 | Drug product | 2023-06-06 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N215179-003 | 11147817 | 2035-03-26 | Drug product | 2023-06-06 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N215179-001 | 11147817 | 2035-03-26 | Drug product | 2023-06-06 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N215179-002 | 11147817 | 2035-03-26 | Drug product | 2023-06-06 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N215179-003 | 11147817 | 2035-03-26 | Drug product | 2023-06-06 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N215179-001 | 11147817 | 2035-03-26 | Drug product | 2023-06-06 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N215179-002 | 11147817 | 2035-03-26 | Drug product | 2023-06-06 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N215179-003 | 11147817 | 2035-03-26 | Drug product | 2023-06-06 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N215179-001 | 11147817 | 2035-03-26 | Drug product | 2023-06-06 | 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 |
|---|---|---|---|---|---|---|
| PEMRYDI RTU | PEMETREXED DISODIUM | Amneal Pharmaceuticals LLC | 0f006b06-ab85-423d-ba0c-dfc3fc25844e | 2025-07-08 | Warnings, Adverse reactions | 215179 NDA215179 |
| Pemetrexed | PEMETREXED DISODIUM | Shilpa Medicare Limited | fe432994-e61b-4a87-8c98-cc20b847d0fe | 2024-11-28 | Warnings, Adverse reactions | 215179 NDA215179 |