FDA.reportPublic FDA data

Application 209604

Type
NDA
Sponsor
ACCORD HLTHCARE

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001GEMCITABINE HYDROCHLORIDEGEMCITABINE HYDROCHLORIDESOLUTION;INTRAVENOUS200MG/2ML (100MG/ML)YesYes
002GEMCITABINE HYDROCHLORIDEGEMCITABINE HYDROCHLORIDESOLUTION;INTRAVENOUS1GM/10ML (100MG/ML)YesYes
003GEMCITABINE HYDROCHLORIDEGEMCITABINE HYDROCHLORIDESOLUTION;INTRAVENOUS1.5GM/15ML (100MG/ML)YesYes
004GEMCITABINE HYDROCHLORIDEGEMCITABINE HYDROCHLORIDESOLUTION;INTRAVENOUS2GM/20ML (100MG/ML)YesYes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N209604-001GEMCITABINE HYDROCHLORIDEGEMCITABINE HYDROCHLORIDE200MG/2ML (100MG/ML)SOLUTION / INTRAVENOUSRLD2017-08-03
N209604-002GEMCITABINE HYDROCHLORIDEGEMCITABINE HYDROCHLORIDE1GM/10ML (100MG/ML)SOLUTION / INTRAVENOUSRLD2017-08-03
N209604-003GEMCITABINE HYDROCHLORIDEGEMCITABINE HYDROCHLORIDE1.5GM/15ML (100MG/ML)SOLUTION / INTRAVENOUSRLD2017-08-03
N209604-004GEMCITABINE HYDROCHLORIDEGEMCITABINE HYDROCHLORIDE2GM/20ML (100MG/ML)SOLUTION / INTRAVENOUSRLD2017-08-03

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.

Product history page 3 of 5 · 176 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2019-12-13 00:20 UTC2019-12N209604-001GEMCITABINE HYDROCHLORIDE200MG/2ML (100MG/ML)SOLUTION / INTRAVENOUSRLD, RS2017-08-0374a2ff9319b5…
2019-12-13 00:20 UTC2019-12N209604-002GEMCITABINE HYDROCHLORIDE1GM/10ML (100MG/ML)SOLUTION / INTRAVENOUSRLD, RS2017-08-0374a2ff9319b5…
2019-12-13 00:20 UTC2019-12N209604-003GEMCITABINE HYDROCHLORIDE1.5GM/15ML (100MG/ML)SOLUTION / INTRAVENOUSRLD, RS2017-08-0374a2ff9319b5…
2019-12-13 00:20 UTC2019-12N209604-004GEMCITABINE HYDROCHLORIDE2GM/20ML (100MG/ML)SOLUTION / INTRAVENOUSRLD, RS2017-08-0374a2ff9319b5…
2022-03-09 01:35 UTC2022-03N209604-001GEMCITABINE HYDROCHLORIDE200MG/2ML (100MG/ML)SOLUTION / INTRAVENOUSRLD, RS2017-08-03bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N209604-002GEMCITABINE HYDROCHLORIDE1GM/10ML (100MG/ML)SOLUTION / INTRAVENOUSRLD, RS2017-08-03bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N209604-003GEMCITABINE HYDROCHLORIDE1.5GM/15ML (100MG/ML)SOLUTION / INTRAVENOUSRLD, RS2017-08-03bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N209604-004GEMCITABINE HYDROCHLORIDE2GM/20ML (100MG/ML)SOLUTION / INTRAVENOUSRLD, RS2017-08-03bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N209604-001GEMCITABINE HYDROCHLORIDE200MG/2ML (100MG/ML)SOLUTION / INTRAVENOUSRLD, RS2017-08-03782e0a99824c…
2021-12-28 21:50 UTC2021-12N209604-002GEMCITABINE HYDROCHLORIDE1GM/10ML (100MG/ML)SOLUTION / INTRAVENOUSRLD, RS2017-08-03782e0a99824c…
2021-12-28 21:50 UTC2021-12N209604-003GEMCITABINE HYDROCHLORIDE1.5GM/15ML (100MG/ML)SOLUTION / INTRAVENOUSRLD, RS2017-08-03782e0a99824c…
2021-12-28 21:50 UTC2021-12N209604-004GEMCITABINE HYDROCHLORIDE2GM/20ML (100MG/ML)SOLUTION / INTRAVENOUSRLD, RS2017-08-03782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N209604-001GEMCITABINE HYDROCHLORIDE200MG/2ML (100MG/ML)SOLUTION / INTRAVENOUSRLD, RS2017-08-0387673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N209604-002GEMCITABINE HYDROCHLORIDE1GM/10ML (100MG/ML)SOLUTION / INTRAVENOUSRLD, RS2017-08-0387673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N209604-003GEMCITABINE HYDROCHLORIDE1.5GM/15ML (100MG/ML)SOLUTION / INTRAVENOUSRLD, RS2017-08-0387673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N209604-004GEMCITABINE HYDROCHLORIDE2GM/20ML (100MG/ML)SOLUTION / INTRAVENOUSRLD, RS2017-08-0387673890dc5c…
2021-03-12 10:30 UTC2021-03N209604-001GEMCITABINE HYDROCHLORIDE200MG/2ML (100MG/ML)SOLUTION / INTRAVENOUSRLD, RS2017-08-035aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03N209604-002GEMCITABINE HYDROCHLORIDE1GM/10ML (100MG/ML)SOLUTION / INTRAVENOUSRLD, RS2017-08-035aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03N209604-003GEMCITABINE HYDROCHLORIDE1.5GM/15ML (100MG/ML)SOLUTION / INTRAVENOUSRLD, RS2017-08-035aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03N209604-004GEMCITABINE HYDROCHLORIDE2GM/20ML (100MG/ML)SOLUTION / INTRAVENOUSRLD, RS2017-08-035aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N209604-001GEMCITABINE HYDROCHLORIDE200MG/2ML (100MG/ML)SOLUTION / INTRAVENOUSRLD, RS2017-08-038869cabd3fbd…
2020-12-22 03:56 UTC2020-12N209604-002GEMCITABINE HYDROCHLORIDE1GM/10ML (100MG/ML)SOLUTION / INTRAVENOUSRLD, RS2017-08-038869cabd3fbd…
2020-12-22 03:56 UTC2020-12N209604-003GEMCITABINE HYDROCHLORIDE1.5GM/15ML (100MG/ML)SOLUTION / INTRAVENOUSRLD, RS2017-08-038869cabd3fbd…
2020-12-22 03:56 UTC2020-12N209604-004GEMCITABINE HYDROCHLORIDE2GM/20ML (100MG/ML)SOLUTION / INTRAVENOUSRLD, RS2017-08-038869cabd3fbd…
2020-11-12 02:37 UTC2020-11N209604-001GEMCITABINE HYDROCHLORIDE200MG/2ML (100MG/ML)SOLUTION / INTRAVENOUSRLD, RS2017-08-03c0c555d07b60…
2020-11-12 02:37 UTC2020-11N209604-002GEMCITABINE HYDROCHLORIDE1GM/10ML (100MG/ML)SOLUTION / INTRAVENOUSRLD, RS2017-08-03c0c555d07b60…
2020-11-12 02:37 UTC2020-11N209604-003GEMCITABINE HYDROCHLORIDE1.5GM/15ML (100MG/ML)SOLUTION / INTRAVENOUSRLD, RS2017-08-03c0c555d07b60…
2020-11-12 02:37 UTC2020-11N209604-004GEMCITABINE HYDROCHLORIDE2GM/20ML (100MG/ML)SOLUTION / INTRAVENOUSRLD, RS2017-08-03c0c555d07b60…
2019-12-14 00:12 UTC2019-12N209604-001GEMCITABINE HYDROCHLORIDE200MG/2ML (100MG/ML)SOLUTION / INTRAVENOUSRLD, RS2017-08-033f01610625f2…
2019-12-14 00:12 UTC2019-12N209604-002GEMCITABINE HYDROCHLORIDE1GM/10ML (100MG/ML)SOLUTION / INTRAVENOUSRLD, RS2017-08-033f01610625f2…
2019-12-14 00:12 UTC2019-12N209604-003GEMCITABINE HYDROCHLORIDE1.5GM/15ML (100MG/ML)SOLUTION / INTRAVENOUSRLD, RS2017-08-033f01610625f2…
2019-12-14 00:12 UTC2019-12N209604-004GEMCITABINE HYDROCHLORIDE2GM/20ML (100MG/ML)SOLUTION / INTRAVENOUSRLD, RS2017-08-033f01610625f2…
2019-09-15 20:21 UTC2019-09N209604-001GEMCITABINE HYDROCHLORIDE200MG/2ML (100MG/ML)SOLUTION / INTRAVENOUSRLD, RS2017-08-03b00525d2431f…
2019-09-15 20:21 UTC2019-09N209604-002GEMCITABINE HYDROCHLORIDE1GM/10ML (100MG/ML)SOLUTION / INTRAVENOUSRLD, RS2017-08-03b00525d2431f…
2019-09-15 20:21 UTC2019-09N209604-003GEMCITABINE HYDROCHLORIDE1.5GM/15ML (100MG/ML)SOLUTION / INTRAVENOUSRLD, RS2017-08-03b00525d2431f…
2019-09-15 20:21 UTC2019-09N209604-004GEMCITABINE HYDROCHLORIDE2GM/20ML (100MG/ML)SOLUTION / INTRAVENOUSRLD, RS2017-08-03b00525d2431f…
2019-07-19 19:46 UTC2019-07N209604-001GEMCITABINE HYDROCHLORIDE200MG/2ML (100MG/ML)SOLUTION / INTRAVENOUSRLD, RS2017-08-03ea99ee380514…
2019-07-19 19:46 UTC2019-07N209604-002GEMCITABINE HYDROCHLORIDE1GM/10ML (100MG/ML)SOLUTION / INTRAVENOUSRLD, RS2017-08-03ea99ee380514…
2019-07-19 19:46 UTC2019-07N209604-003GEMCITABINE HYDROCHLORIDE1.5GM/15ML (100MG/ML)SOLUTION / INTRAVENOUSRLD, RS2017-08-03ea99ee380514…
2019-07-19 19:46 UTC2019-07N209604-004GEMCITABINE HYDROCHLORIDE2GM/20ML (100MG/ML)SOLUTION / INTRAVENOUSRLD, RS2017-08-03ea99ee380514…

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.

Matched openFDA labels page 1 of 1 · 7 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
GemcitabineGEMCITABINE HYDROCHLORIDEMeitheal Pharmaceuticals Inc.c0b1b715-9ff8-43ca-9e49-465f1f3800842025-07-23Warnings, Adverse reactionsName fallback
generic name: GEMCITABINE HYDROCHLORIDE
GEMCITABINEGEMCITABINE HYDROCHLORIDENorthStar Rx LLC5af49a48-f1c0-467d-b5da-ac9f1ae8e34c2025-02-03Warnings, Adverse reactionsName fallback
generic name: GEMCITABINE HYDROCHLORIDE
GEMCITABINEGEMCITABINE HYDROCHLORIDEMeitheal Pharmaceuticals Inc.a5949d02-29eb-4626-ad35-b7614bb0fa952025-01-29Warnings, Adverse reactionsName fallback
generic name: GEMCITABINE HYDROCHLORIDE
Gemcitabine hydrochlorideGEMCITABINE HYDROCHLORIDETeyro Labs Private Limiteda6ddaa2f-4c17-430f-a7cd-96b6662923f62025-01-09Warnings, Adverse reactionsName fallback
brand name: Gemcitabine hydrochloride
generic name: GEMCITABINE HYDROCHLORIDE
GemcitabineGEMCITABINE HYDROCHLORIDEMylan Institutional LLC06dd9d40-74fc-4409-93b1-a46be71263312024-11-11Warnings, Adverse reactionsName fallback
generic name: GEMCITABINE HYDROCHLORIDE
gemcitabine hydrochlorideGEMCITABINE HYDROCHLORIDEGland Pharma Limited9f8fe5ba-943f-4f0a-9618-6083101faa282024-09-06Warnings, Adverse reactionsName fallback
brand name: gemcitabine hydrochloride
generic name: GEMCITABINE HYDROCHLORIDE
GemcitabineGEMCITABINE HYDROCHLORIDEMeitheal Pharmaceuticals Inc.73ae04d8-38f9-4d3d-b0c2-71d22af1fc862024-08-05Warnings, Adverse reactionsName fallback
generic name: GEMCITABINE HYDROCHLORIDE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 24 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
16729-391GEMCITABINEGEMCITABINEAccord Healthcare Inc.NDACurrent
16729-391GEMCITABINEGEMCITABINEAccord Healthcare Inc.NDACurrent
16729-391GEMCITABINEGEMCITABINEAccord Healthcare Inc.NDACurrent
16729-419GEMCITABINEGEMCITABINEAccord Healthcare Inc.NDACurrent
16729-419GEMCITABINEGEMCITABINEAccord Healthcare Inc.NDACurrent
16729-419GEMCITABINEGEMCITABINEAccord Healthcare Inc.NDACurrent
16729-423GEMCITABINEGEMCITABINEAccord Healthcare Inc.NDACurrent
16729-423GEMCITABINEGEMCITABINEAccord Healthcare Inc.NDACurrent
16729-423GEMCITABINEGEMCITABINEAccord Healthcare Inc.NDACurrent
16729-426GEMCITABINEGEMCITABINEAccord Healthcare Inc.NDACurrent
16729-426GEMCITABINEGEMCITABINEAccord Healthcare Inc.NDACurrent
16729-426GEMCITABINEGEMCITABINEAccord Healthcare Inc.NDACurrent
68001-342GEMCITABINEGEMCITABINEBluePoint LaboratoriesNDACurrent
68001-342GEMCITABINEGEMCITABINEBluePoint LaboratoriesNDACurrent
68001-342GEMCITABINEGEMCITABINEBluePoint LaboratoriesNDACurrent
68001-348GEMCITABINEGEMCITABINEBluePoint LaboratoriesNDACurrent
68001-348GEMCITABINEGEMCITABINEBluePoint LaboratoriesNDACurrent
68001-348GEMCITABINEGEMCITABINEBluePoint LaboratoriesNDACurrent
68001-350GEMCITABINEGEMCITABINEBluePoint LaboratoriesNDACurrent
68001-350GEMCITABINEGEMCITABINEBluePoint LaboratoriesNDACurrent
68001-350GEMCITABINEGEMCITABINEBluePoint LaboratoriesNDACurrent
68001-359GEMCITABINEGEMCITABINEBluePoint LaboratoriesNDACurrent
68001-359GEMCITABINEGEMCITABINEBluePoint LaboratoriesNDACurrent
68001-359GEMCITABINEGEMCITABINEBluePoint LaboratoriesNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
79739SUPPL 2024-09-26
79734SUPPL 2024-09-26
59182SUPPL2019-06-27
59173SUPPL2019-06-26
56923SUPPL2018-12-21
56906SUPPL2018-12-20
55083SUPPL2018-08-03
55066SUPPL2018-07-31
50203ORIG2017-10-27
49255ORIG2017-08-07
49240ORIG2017-08-04