Application 209604
- Type
- NDA
- Sponsor
- ACCORD HLTHCARE
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | GEMCITABINE HYDROCHLORIDE | GEMCITABINE HYDROCHLORIDE | SOLUTION;INTRAVENOUS | 200MG/2ML (100MG/ML) | Yes | Yes |
| 002 | GEMCITABINE HYDROCHLORIDE | GEMCITABINE HYDROCHLORIDE | SOLUTION;INTRAVENOUS | 1GM/10ML (100MG/ML) | Yes | Yes |
| 003 | GEMCITABINE HYDROCHLORIDE | GEMCITABINE HYDROCHLORIDE | SOLUTION;INTRAVENOUS | 1.5GM/15ML (100MG/ML) | Yes | Yes |
| 004 | GEMCITABINE HYDROCHLORIDE | GEMCITABINE HYDROCHLORIDE | SOLUTION;INTRAVENOUS | 2GM/20ML (100MG/ML) | Yes | Yes |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N209604-001 | GEMCITABINE HYDROCHLORIDE | GEMCITABINE HYDROCHLORIDE | 200MG/2ML (100MG/ML) | SOLUTION / INTRAVENOUS | RLD | 2017-08-03 | |
| N209604-002 | GEMCITABINE HYDROCHLORIDE | GEMCITABINE HYDROCHLORIDE | 1GM/10ML (100MG/ML) | SOLUTION / INTRAVENOUS | RLD | 2017-08-03 | |
| N209604-003 | GEMCITABINE HYDROCHLORIDE | GEMCITABINE HYDROCHLORIDE | 1.5GM/15ML (100MG/ML) | SOLUTION / INTRAVENOUS | RLD | 2017-08-03 | |
| N209604-004 | GEMCITABINE HYDROCHLORIDE | GEMCITABINE HYDROCHLORIDE | 2GM/20ML (100MG/ML) | SOLUTION / INTRAVENOUS | RLD | 2017-08-03 |
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 | N209604-001 | GEMCITABINE HYDROCHLORIDE | 200MG/2ML (100MG/ML) | SOLUTION / INTRAVENOUS | RLD | 2017-08-03 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N209604-002 | GEMCITABINE HYDROCHLORIDE | 1GM/10ML (100MG/ML) | SOLUTION / INTRAVENOUS | RLD | 2017-08-03 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N209604-003 | GEMCITABINE HYDROCHLORIDE | 1.5GM/15ML (100MG/ML) | SOLUTION / INTRAVENOUS | RLD | 2017-08-03 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N209604-004 | GEMCITABINE HYDROCHLORIDE | 2GM/20ML (100MG/ML) | SOLUTION / INTRAVENOUS | RLD | 2017-08-03 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | N209604-001 | GEMCITABINE HYDROCHLORIDE | 200MG/2ML (100MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2017-08-03 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N209604-002 | GEMCITABINE HYDROCHLORIDE | 1GM/10ML (100MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2017-08-03 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N209604-003 | GEMCITABINE HYDROCHLORIDE | 1.5GM/15ML (100MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2017-08-03 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N209604-004 | GEMCITABINE HYDROCHLORIDE | 2GM/20ML (100MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2017-08-03 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N209604-001 | GEMCITABINE HYDROCHLORIDE | 200MG/2ML (100MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2017-08-03 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N209604-002 | GEMCITABINE HYDROCHLORIDE | 1GM/10ML (100MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2017-08-03 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N209604-003 | GEMCITABINE HYDROCHLORIDE | 1.5GM/15ML (100MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2017-08-03 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N209604-004 | GEMCITABINE HYDROCHLORIDE | 2GM/20ML (100MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2017-08-03 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N209604-001 | GEMCITABINE HYDROCHLORIDE | 200MG/2ML (100MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2017-08-03 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N209604-002 | GEMCITABINE HYDROCHLORIDE | 1GM/10ML (100MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2017-08-03 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N209604-003 | GEMCITABINE HYDROCHLORIDE | 1.5GM/15ML (100MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2017-08-03 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N209604-004 | GEMCITABINE HYDROCHLORIDE | 2GM/20ML (100MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2017-08-03 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N209604-001 | GEMCITABINE HYDROCHLORIDE | 200MG/2ML (100MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2017-08-03 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N209604-002 | GEMCITABINE HYDROCHLORIDE | 1GM/10ML (100MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2017-08-03 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N209604-003 | GEMCITABINE HYDROCHLORIDE | 1.5GM/15ML (100MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2017-08-03 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N209604-004 | GEMCITABINE HYDROCHLORIDE | 2GM/20ML (100MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2017-08-03 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N209604-001 | GEMCITABINE HYDROCHLORIDE | 200MG/2ML (100MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2017-08-03 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N209604-002 | GEMCITABINE HYDROCHLORIDE | 1GM/10ML (100MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2017-08-03 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N209604-003 | GEMCITABINE HYDROCHLORIDE | 1.5GM/15ML (100MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2017-08-03 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N209604-004 | GEMCITABINE HYDROCHLORIDE | 2GM/20ML (100MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2017-08-03 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N209604-001 | GEMCITABINE HYDROCHLORIDE | 200MG/2ML (100MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2017-08-03 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N209604-002 | GEMCITABINE HYDROCHLORIDE | 1GM/10ML (100MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2017-08-03 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N209604-003 | GEMCITABINE HYDROCHLORIDE | 1.5GM/15ML (100MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2017-08-03 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N209604-004 | GEMCITABINE HYDROCHLORIDE | 2GM/20ML (100MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2017-08-03 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N209604-001 | GEMCITABINE HYDROCHLORIDE | 200MG/2ML (100MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2017-08-03 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N209604-002 | GEMCITABINE HYDROCHLORIDE | 1GM/10ML (100MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2017-08-03 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N209604-003 | GEMCITABINE HYDROCHLORIDE | 1.5GM/15ML (100MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2017-08-03 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N209604-004 | GEMCITABINE HYDROCHLORIDE | 2GM/20ML (100MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2017-08-03 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N209604-001 | GEMCITABINE HYDROCHLORIDE | 200MG/2ML (100MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2017-08-03 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N209604-002 | GEMCITABINE HYDROCHLORIDE | 1GM/10ML (100MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2017-08-03 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N209604-003 | GEMCITABINE HYDROCHLORIDE | 1.5GM/15ML (100MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2017-08-03 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N209604-004 | GEMCITABINE HYDROCHLORIDE | 2GM/20ML (100MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2017-08-03 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N209604-001 | GEMCITABINE HYDROCHLORIDE | 200MG/2ML (100MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2017-08-03 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N209604-002 | GEMCITABINE HYDROCHLORIDE | 1GM/10ML (100MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2017-08-03 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N209604-003 | GEMCITABINE HYDROCHLORIDE | 1.5GM/15ML (100MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2017-08-03 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N209604-004 | GEMCITABINE HYDROCHLORIDE | 2GM/20ML (100MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2017-08-03 | 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 |
|---|---|---|---|---|---|---|
| GEMCITABINE | GEMCITABINE | BluePoint Laboratories | 4031017d-d768-46de-8081-476bcb883f5e | 2023-09-11 | Warnings, Adverse reactions | 209604 NDA209604 68001-350 68001-348 68001-359 68001-342 |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 16729-391 | GEMCITABINE | GEMCITABINE | Accord Healthcare Inc. | NDA | Current |
| 16729-391 | GEMCITABINE | GEMCITABINE | Accord Healthcare Inc. | NDA | Current |
| 16729-391 | GEMCITABINE | GEMCITABINE | Accord Healthcare Inc. | NDA | Current |
| 16729-419 | GEMCITABINE | GEMCITABINE | Accord Healthcare Inc. | NDA | Current |
| 16729-419 | GEMCITABINE | GEMCITABINE | Accord Healthcare Inc. | NDA | Current |
| 16729-419 | GEMCITABINE | GEMCITABINE | Accord Healthcare Inc. | NDA | Current |
| 16729-423 | GEMCITABINE | GEMCITABINE | Accord Healthcare Inc. | NDA | Current |
| 16729-423 | GEMCITABINE | GEMCITABINE | Accord Healthcare Inc. | NDA | Current |
| 16729-423 | GEMCITABINE | GEMCITABINE | Accord Healthcare Inc. | NDA | Current |
| 16729-426 | GEMCITABINE | GEMCITABINE | Accord Healthcare Inc. | NDA | Current |
| 16729-426 | GEMCITABINE | GEMCITABINE | Accord Healthcare Inc. | NDA | Current |
| 16729-426 | GEMCITABINE | GEMCITABINE | Accord Healthcare Inc. | NDA | Current |
| 68001-342 | GEMCITABINE | GEMCITABINE | BluePoint Laboratories | NDA | Current |
| 68001-342 | GEMCITABINE | GEMCITABINE | BluePoint Laboratories | NDA | Current |
| 68001-342 | GEMCITABINE | GEMCITABINE | BluePoint Laboratories | NDA | Current |
| 68001-348 | GEMCITABINE | GEMCITABINE | BluePoint Laboratories | NDA | Current |
| 68001-348 | GEMCITABINE | GEMCITABINE | BluePoint Laboratories | NDA | Current |
| 68001-348 | GEMCITABINE | GEMCITABINE | BluePoint Laboratories | NDA | Current |
| 68001-350 | GEMCITABINE | GEMCITABINE | BluePoint Laboratories | NDA | Current |
| 68001-350 | GEMCITABINE | GEMCITABINE | BluePoint Laboratories | NDA | Current |
| 68001-350 | GEMCITABINE | GEMCITABINE | BluePoint Laboratories | NDA | Current |
| 68001-359 | GEMCITABINE | GEMCITABINE | BluePoint Laboratories | NDA | Current |
| 68001-359 | GEMCITABINE | GEMCITABINE | BluePoint Laboratories | NDA | Current |
| 68001-359 | GEMCITABINE | GEMCITABINE | BluePoint Laboratories | NDA | Current |