Application 079160
- Type
- ANDA
- Sponsor
- ACTAVIS TOTOWA
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | GEMCITABINE HYDROCHLORIDE | GEMCITABINE HYDROCHLORIDE | INJECTABLE;INJECTION | EQ 200MG BASE/VIAL | No | No |
| 002 | GEMCITABINE HYDROCHLORIDE | GEMCITABINE HYDROCHLORIDE | INJECTABLE;INJECTION | EQ 1GM BASE/VIAL | No | No |
| 003 | GEMCITABINE HYDROCHLORIDE | GEMCITABINE HYDROCHLORIDE | INJECTABLE;INJECTION | EQ 2GM BASE/VIAL | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A079160-001 | GEMCITABINE HYDROCHLORIDE | GEMCITABINE HYDROCHLORIDE | EQ 200MG BASE/VIAL | INJECTABLE / INJECTION | 2011-07-25 | ||
| A079160-002 | GEMCITABINE HYDROCHLORIDE | GEMCITABINE HYDROCHLORIDE | EQ 1GM BASE/VIAL | INJECTABLE / INJECTION | 2011-07-25 | ||
| A079160-003 | GEMCITABINE HYDROCHLORIDE | GEMCITABINE HYDROCHLORIDE | EQ 2GM BASE/VIAL | INJECTABLE / INJECTION | 2016-07-28 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A079160-001 | GEMCITABINE HYDROCHLORIDE | EQ 200MG BASE/VIAL | INJECTABLE / INJECTION | 2011-07-25 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A079160-002 | GEMCITABINE HYDROCHLORIDE | EQ 1GM BASE/VIAL | INJECTABLE / INJECTION | 2011-07-25 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A079160-003 | GEMCITABINE HYDROCHLORIDE | EQ 2GM BASE/VIAL | INJECTABLE / INJECTION | 2016-07-28 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A079160-001 | GEMCITABINE HYDROCHLORIDE | EQ 200MG BASE/VIAL | INJECTABLE / INJECTION | 2011-07-25 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A079160-002 | GEMCITABINE HYDROCHLORIDE | EQ 1GM BASE/VIAL | INJECTABLE / INJECTION | 2011-07-25 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A079160-003 | GEMCITABINE HYDROCHLORIDE | EQ 2GM BASE/VIAL | INJECTABLE / INJECTION | 2016-07-28 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A079160-001 | GEMCITABINE HYDROCHLORIDE | EQ 200MG BASE/VIAL | INJECTABLE / INJECTION | 2011-07-25 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A079160-002 | GEMCITABINE HYDROCHLORIDE | EQ 1GM BASE/VIAL | INJECTABLE / INJECTION | 2011-07-25 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A079160-003 | GEMCITABINE HYDROCHLORIDE | EQ 2GM BASE/VIAL | INJECTABLE / INJECTION | 2016-07-28 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A079160-001 | GEMCITABINE HYDROCHLORIDE | EQ 200MG BASE/VIAL | INJECTABLE / INJECTION | 2011-07-25 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A079160-002 | GEMCITABINE HYDROCHLORIDE | EQ 1GM BASE/VIAL | INJECTABLE / INJECTION | 2011-07-25 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A079160-003 | GEMCITABINE HYDROCHLORIDE | EQ 2GM BASE/VIAL | INJECTABLE / INJECTION | 2016-07-28 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A079160-001 | GEMCITABINE HYDROCHLORIDE | EQ 200MG BASE/VIAL | INJECTABLE / INJECTION | 2011-07-25 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A079160-002 | GEMCITABINE HYDROCHLORIDE | EQ 1GM BASE/VIAL | INJECTABLE / INJECTION | 2011-07-25 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A079160-003 | GEMCITABINE HYDROCHLORIDE | EQ 2GM BASE/VIAL | INJECTABLE / INJECTION | 2016-07-28 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A079160-001 | GEMCITABINE HYDROCHLORIDE | EQ 200MG BASE/VIAL | INJECTABLE / INJECTION | 2011-07-25 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A079160-002 | GEMCITABINE HYDROCHLORIDE | EQ 1GM BASE/VIAL | INJECTABLE / INJECTION | 2011-07-25 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A079160-003 | GEMCITABINE HYDROCHLORIDE | EQ 2GM BASE/VIAL | INJECTABLE / INJECTION | 2016-07-28 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A079160-001 | GEMCITABINE HYDROCHLORIDE | EQ 200MG BASE/VIAL | INJECTABLE / INJECTION | 2011-07-25 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A079160-002 | GEMCITABINE HYDROCHLORIDE | EQ 1GM BASE/VIAL | INJECTABLE / INJECTION | 2011-07-25 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A079160-003 | GEMCITABINE HYDROCHLORIDE | EQ 2GM BASE/VIAL | INJECTABLE / INJECTION | 2016-07-28 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A079160-001 | GEMCITABINE HYDROCHLORIDE | EQ 200MG BASE/VIAL | INJECTABLE / INJECTION | 2011-07-25 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A079160-002 | GEMCITABINE HYDROCHLORIDE | EQ 1GM BASE/VIAL | INJECTABLE / INJECTION | 2011-07-25 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A079160-003 | GEMCITABINE HYDROCHLORIDE | EQ 2GM BASE/VIAL | INJECTABLE / INJECTION | 2016-07-28 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A079160-001 | GEMCITABINE HYDROCHLORIDE | EQ 200MG BASE/VIAL | INJECTABLE / INJECTION | 2011-07-25 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A079160-002 | GEMCITABINE HYDROCHLORIDE | EQ 1GM BASE/VIAL | INJECTABLE / INJECTION | 2011-07-25 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A079160-003 | GEMCITABINE HYDROCHLORIDE | EQ 2GM BASE/VIAL | INJECTABLE / INJECTION | 2016-07-28 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A079160-001 | GEMCITABINE HYDROCHLORIDE | EQ 200MG BASE/VIAL | INJECTABLE / INJECTION | 2011-07-25 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A079160-002 | GEMCITABINE HYDROCHLORIDE | EQ 1GM BASE/VIAL | INJECTABLE / INJECTION | 2011-07-25 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A079160-003 | GEMCITABINE HYDROCHLORIDE | EQ 2GM BASE/VIAL | INJECTABLE / INJECTION | 2016-07-28 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A079160-001 | GEMCITABINE HYDROCHLORIDE | EQ 200MG BASE/VIAL | INJECTABLE / INJECTION | 2011-07-25 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A079160-002 | GEMCITABINE HYDROCHLORIDE | EQ 1GM BASE/VIAL | INJECTABLE / INJECTION | 2011-07-25 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A079160-003 | GEMCITABINE HYDROCHLORIDE | EQ 2GM BASE/VIAL | INJECTABLE / INJECTION | 2016-07-28 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A079160-001 | GEMCITABINE HYDROCHLORIDE | EQ 200MG BASE/VIAL | INJECTABLE / INJECTION | 2011-07-25 | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A079160-002 | GEMCITABINE HYDROCHLORIDE | EQ 1GM BASE/VIAL | INJECTABLE / INJECTION | 2011-07-25 | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A079160-003 | GEMCITABINE HYDROCHLORIDE | EQ 2GM BASE/VIAL | INJECTABLE / INJECTION | 2016-07-28 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A079160-001 | GEMCITABINE HYDROCHLORIDE | EQ 200MG BASE/VIAL | INJECTABLE / INJECTION | 2011-07-25 | 1e350fbaab3a… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A079160-002 | GEMCITABINE HYDROCHLORIDE | EQ 1GM BASE/VIAL | INJECTABLE / INJECTION | 2011-07-25 | 1e350fbaab3a… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A079160-003 | GEMCITABINE HYDROCHLORIDE | EQ 2GM BASE/VIAL | INJECTABLE / INJECTION | 2016-07-28 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A079160-001 | GEMCITABINE HYDROCHLORIDE | EQ 200MG BASE/VIAL | INJECTABLE / INJECTION | 2011-07-25 | 8072bd15b7f6… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2019-12-13 00:20 UTC | 2019-12 | A079160-001 | AP | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A079160-002 | AP | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A079160-003 | AP | 1 | 74a2ff9319b5… |
| 2019-12-14 00:12 UTC | 2019-12 | A079160-001 | AP | 1 | 3f01610625f2… |
| 2019-12-14 00:12 UTC | 2019-12 | A079160-002 | AP | 1 | 3f01610625f2… |
| 2019-12-14 00:12 UTC | 2019-12 | A079160-003 | AP | 1 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | A079160-001 | AP | 1 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | A079160-002 | AP | 1 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | A079160-003 | AP | 1 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | A079160-001 | AP | 1 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | A079160-002 | AP | 1 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | A079160-003 | AP | 1 | ea99ee380514… |
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 | Sagent Pharmaceuticals | 44bcc16c-341d-49e8-a1c6-95d084667aca | 2024-09-06 | Warnings, Adverse reactions | GEMCITABINE HYDROCHLORIDE |
| Gemcitabine | GEMCITABINE HYDROCHLORIDE | Meitheal Pharmaceuticals Inc. | 73ae04d8-38f9-4d3d-b0c2-71d22af1fc86 | 2024-08-05 | Warnings, Adverse reactions | GEMCITABINE HYDROCHLORIDE |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 45963-612 | gemcitabine hydrochloride | gemcitabine hydrochloride | Actavis Pharma, Inc. | ANDA | Current |
| 45963-612 | gemcitabine hydrochloride | gemcitabine hydrochloride | Actavis Pharma, Inc. | ANDA | Current |
| 45963-612 | gemcitabine hydrochloride | gemcitabine hydrochloride | Actavis Pharma, Inc. | ANDA | Current |
| 45963-612 | gemcitabine hydrochloride | gemcitabine hydrochloride | Actavis Pharma, Inc. | ANDA | Current |
| 45963-619 | gemcitabine hydrochloride | gemcitabine hydrochloride | Actavis Pharma, Inc. | ANDA | Current |
| 45963-619 | gemcitabine hydrochloride | gemcitabine hydrochloride | Actavis Pharma, Inc. | ANDA | Current |
| 45963-619 | gemcitabine hydrochloride | gemcitabine hydrochloride | Actavis Pharma, Inc. | ANDA | Current |
| 45963-619 | gemcitabine hydrochloride | gemcitabine hydrochloride | Actavis Pharma, Inc. | ANDA | Current |
| 45963-620 | gemcitabine hydrochloride | gemcitabine hydrochloride | Actavis Pharma, Inc. | ANDA | Current |
| 45963-620 | gemcitabine hydrochloride | gemcitabine hydrochloride | Actavis Pharma, Inc. | ANDA | Current |
| 45963-620 | gemcitabine hydrochloride | gemcitabine hydrochloride | Actavis Pharma, Inc. | ANDA | Current |