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 |
|---|---|---|---|---|---|---|---|---|---|
| 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… | |
| 2024-10-29 15:01 UTC | 2024-10 | N209604-001 | GEMCITABINE HYDROCHLORIDE | 200MG/2ML (100MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2017-08-03 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N209604-002 | GEMCITABINE HYDROCHLORIDE | 1GM/10ML (100MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2017-08-03 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N209604-003 | GEMCITABINE HYDROCHLORIDE | 1.5GM/15ML (100MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2017-08-03 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N209604-004 | GEMCITABINE HYDROCHLORIDE | 2GM/20ML (100MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2017-08-03 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N209604-001 | GEMCITABINE HYDROCHLORIDE | 200MG/2ML (100MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2017-08-03 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N209604-002 | GEMCITABINE HYDROCHLORIDE | 1GM/10ML (100MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2017-08-03 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N209604-003 | GEMCITABINE HYDROCHLORIDE | 1.5GM/15ML (100MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2017-08-03 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N209604-004 | GEMCITABINE HYDROCHLORIDE | 2GM/20ML (100MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2017-08-03 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N209604-001 | GEMCITABINE HYDROCHLORIDE | 200MG/2ML (100MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2017-08-03 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N209604-002 | GEMCITABINE HYDROCHLORIDE | 1GM/10ML (100MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2017-08-03 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N209604-003 | GEMCITABINE HYDROCHLORIDE | 1.5GM/15ML (100MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2017-08-03 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N209604-004 | GEMCITABINE HYDROCHLORIDE | 2GM/20ML (100MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2017-08-03 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N209604-001 | GEMCITABINE HYDROCHLORIDE | 200MG/2ML (100MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2017-08-03 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N209604-002 | GEMCITABINE HYDROCHLORIDE | 1GM/10ML (100MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2017-08-03 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N209604-003 | GEMCITABINE HYDROCHLORIDE | 1.5GM/15ML (100MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2017-08-03 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N209604-004 | GEMCITABINE HYDROCHLORIDE | 2GM/20ML (100MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2017-08-03 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | N209604-001 | GEMCITABINE HYDROCHLORIDE | 200MG/2ML (100MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2017-08-03 | 8072bd15b7f6… | |
| 2024-05-31 18:47 UTC | 2024-05 | N209604-002 | GEMCITABINE HYDROCHLORIDE | 1GM/10ML (100MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2017-08-03 | 8072bd15b7f6… | |
| 2024-05-31 18:47 UTC | 2024-05 | N209604-003 | GEMCITABINE HYDROCHLORIDE | 1.5GM/15ML (100MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2017-08-03 | 8072bd15b7f6… | |
| 2024-05-31 18:47 UTC | 2024-05 | N209604-004 | GEMCITABINE HYDROCHLORIDE | 2GM/20ML (100MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2017-08-03 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N209604-001 | GEMCITABINE HYDROCHLORIDE | 200MG/2ML (100MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2017-08-03 | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N209604-002 | GEMCITABINE HYDROCHLORIDE | 1GM/10ML (100MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2017-08-03 | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N209604-003 | GEMCITABINE HYDROCHLORIDE | 1.5GM/15ML (100MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2017-08-03 | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N209604-004 | GEMCITABINE HYDROCHLORIDE | 2GM/20ML (100MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2017-08-03 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | N209604-001 | GEMCITABINE HYDROCHLORIDE | 200MG/2ML (100MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2017-08-03 | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | N209604-002 | GEMCITABINE HYDROCHLORIDE | 1GM/10ML (100MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2017-08-03 | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | N209604-003 | GEMCITABINE HYDROCHLORIDE | 1.5GM/15ML (100MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2017-08-03 | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | N209604-004 | GEMCITABINE HYDROCHLORIDE | 2GM/20ML (100MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2017-08-03 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | N209604-001 | GEMCITABINE HYDROCHLORIDE | 200MG/2ML (100MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2017-08-03 | 4b0b4de00fa7… | |
| 2022-04-04 05:41 UTC | 2022-04 | N209604-002 | GEMCITABINE HYDROCHLORIDE | 1GM/10ML (100MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2017-08-03 | 4b0b4de00fa7… | |
| 2022-04-04 05:41 UTC | 2022-04 | N209604-003 | GEMCITABINE HYDROCHLORIDE | 1.5GM/15ML (100MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2017-08-03 | 4b0b4de00fa7… | |
| 2022-04-04 05:41 UTC | 2022-04 | N209604-004 | GEMCITABINE HYDROCHLORIDE | 2GM/20ML (100MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2017-08-03 | 4b0b4de00fa7… |
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 HYDROCHLORIDE | Meitheal Pharmaceuticals Inc. | c0b1b715-9ff8-43ca-9e49-465f1f380084 | 2025-07-23 | Warnings, Adverse reactions | GEMCITABINE HYDROCHLORIDE |
| GEMCITABINE | GEMCITABINE HYDROCHLORIDE | NorthStar Rx LLC | 5af49a48-f1c0-467d-b5da-ac9f1ae8e34c | 2025-02-03 | Warnings, Adverse reactions | GEMCITABINE HYDROCHLORIDE |
| GEMCITABINE | GEMCITABINE HYDROCHLORIDE | Meitheal Pharmaceuticals Inc. | a5949d02-29eb-4626-ad35-b7614bb0fa95 | 2025-01-29 | Warnings, Adverse reactions | GEMCITABINE HYDROCHLORIDE |
| Gemcitabine hydrochloride | GEMCITABINE HYDROCHLORIDE | Teyro Labs Private Limited | a6ddaa2f-4c17-430f-a7cd-96b6662923f6 | 2025-01-09 | Warnings, Adverse reactions | Gemcitabine hydrochloride GEMCITABINE HYDROCHLORIDE |
| Gemcitabine | GEMCITABINE HYDROCHLORIDE | Mylan Institutional LLC | 06dd9d40-74fc-4409-93b1-a46be7126331 | 2024-11-11 | Warnings, Adverse reactions | GEMCITABINE HYDROCHLORIDE |
| gemcitabine hydrochloride | GEMCITABINE HYDROCHLORIDE | Gland Pharma Limited | 9f8fe5ba-943f-4f0a-9618-6083101faa28 | 2024-09-06 | Warnings, Adverse reactions | gemcitabine hydrochloride GEMCITABINE HYDROCHLORIDE |
| Gemcitabine | GEMCITABINE HYDROCHLORIDE | Meitheal Pharmaceuticals Inc. | 73ae04d8-38f9-4d3d-b0c2-71d22af1fc86 | 2024-08-05 | Warnings, Adverse reactions | GEMCITABINE HYDROCHLORIDE |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
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 |