Home Applications 020047 Application 020047
Type NDA
Sponsor BAXTER HLTHCARE Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 DEXTROSE 50% IN PLASTIC CONTAINER DEXTROSE INJECTABLE;INJECTION 50GM/100ML Yes Yes 002 DEXTROSE 60% IN PLASTIC CONTAINER DEXTROSE INJECTABLE;INJECTION 60GM/100ML No No 003 DEXTROSE 70% IN PLASTIC CONTAINER DEXTROSE INJECTABLE;INJECTION 70GM/100ML Yes Yes
Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
Orange Book products# Current product rows page 1 of 1 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N020047-001 DEXTROSE 50% IN PLASTIC CONTAINER DEXTROSE 50GM/100ML INJECTABLE / INJECTION AP RLD, RS 1991-07-02 N020047-002 DEXTROSE 60% IN PLASTIC CONTAINER DEXTROSE 60GM/100ML INJECTABLE / INJECTION 1991-07-02 N020047-003 DEXTROSE 70% IN PLASTIC CONTAINER DEXTROSE 70GM/100ML INJECTABLE / INJECTION AP RLD, RS 1991-07-02
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
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 2 of 4 · 132 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N020047-002 DEXTROSE 60% IN PLASTIC CONTAINER 60GM/100ML INJECTABLE / INJECTION 1991-07-02 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N020047-003 DEXTROSE 70% IN PLASTIC CONTAINER 70GM/100ML INJECTABLE / INJECTION AP RLD, RS 1991-07-02 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N020047-001 DEXTROSE 50% IN PLASTIC CONTAINER 50GM/100ML INJECTABLE / INJECTION AP RLD, RS 1991-07-02 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N020047-002 DEXTROSE 60% IN PLASTIC CONTAINER 60GM/100ML INJECTABLE / INJECTION 1991-07-02 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N020047-003 DEXTROSE 70% IN PLASTIC CONTAINER 70GM/100ML INJECTABLE / INJECTION AP RLD, RS 1991-07-02 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N020047-001 DEXTROSE 50% IN PLASTIC CONTAINER 50GM/100ML INJECTABLE / INJECTION AP RLD, RS 1991-07-02 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N020047-002 DEXTROSE 60% IN PLASTIC CONTAINER 60GM/100ML INJECTABLE / INJECTION 1991-07-02 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N020047-003 DEXTROSE 70% IN PLASTIC CONTAINER 70GM/100ML INJECTABLE / INJECTION AP RLD, RS 1991-07-02 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N020047-001 DEXTROSE 50% IN PLASTIC CONTAINER 50GM/100ML INJECTABLE / INJECTION AP RLD, RS 1991-07-02 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N020047-002 DEXTROSE 60% IN PLASTIC CONTAINER 60GM/100ML INJECTABLE / INJECTION 1991-07-02 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N020047-003 DEXTROSE 70% IN PLASTIC CONTAINER 70GM/100ML INJECTABLE / INJECTION AP RLD, RS 1991-07-02 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N020047-001 DEXTROSE 50% IN PLASTIC CONTAINER 50GM/100ML INJECTABLE / INJECTION AP RLD, RS 1991-07-02 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N020047-002 DEXTROSE 60% IN PLASTIC CONTAINER 60GM/100ML INJECTABLE / INJECTION 1991-07-02 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N020047-003 DEXTROSE 70% IN PLASTIC CONTAINER 70GM/100ML INJECTABLE / INJECTION AP RLD, RS 1991-07-02 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N020047-001 DEXTROSE 50% IN PLASTIC CONTAINER 50GM/100ML INJECTABLE / INJECTION AP RLD, RS 1991-07-02 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N020047-002 DEXTROSE 60% IN PLASTIC CONTAINER 60GM/100ML INJECTABLE / INJECTION 1991-07-02 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N020047-003 DEXTROSE 70% IN PLASTIC CONTAINER 70GM/100ML INJECTABLE / INJECTION AP RLD, RS 1991-07-02 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N020047-001 DEXTROSE 50% IN PLASTIC CONTAINER 50GM/100ML INJECTABLE / INJECTION AP RLD, RS 1991-07-02 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N020047-002 DEXTROSE 60% IN PLASTIC CONTAINER 60GM/100ML INJECTABLE / INJECTION 1991-07-02 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N020047-003 DEXTROSE 70% IN PLASTIC CONTAINER 70GM/100ML INJECTABLE / INJECTION AP RLD, RS 1991-07-02 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N020047-001 DEXTROSE 50% IN PLASTIC CONTAINER 50GM/100ML INJECTABLE / INJECTION AP RLD, RS 1991-07-02 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N020047-002 DEXTROSE 60% IN PLASTIC CONTAINER 60GM/100ML INJECTABLE / INJECTION 1991-07-02 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N020047-003 DEXTROSE 70% IN PLASTIC CONTAINER 70GM/100ML INJECTABLE / INJECTION AP RLD, RS 1991-07-02 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N020047-001 DEXTROSE 50% IN PLASTIC CONTAINER 50GM/100ML INJECTABLE / INJECTION AP RLD, RS 1991-07-02 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N020047-002 DEXTROSE 60% IN PLASTIC CONTAINER 60GM/100ML INJECTABLE / INJECTION 1991-07-02 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N020047-003 DEXTROSE 70% IN PLASTIC CONTAINER 70GM/100ML INJECTABLE / INJECTION AP RLD, RS 1991-07-02 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N020047-001 DEXTROSE 50% IN PLASTIC CONTAINER 50GM/100ML INJECTABLE / INJECTION AP RLD, RS 1991-07-02 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N020047-002 DEXTROSE 60% IN PLASTIC CONTAINER 60GM/100ML INJECTABLE / INJECTION 1991-07-02 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N020047-003 DEXTROSE 70% IN PLASTIC CONTAINER 70GM/100ML INJECTABLE / INJECTION AP RLD, RS 1991-07-02 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N020047-001 DEXTROSE 50% IN PLASTIC CONTAINER 50GM/100ML INJECTABLE / INJECTION AP RLD, RS 1991-07-02 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N020047-002 DEXTROSE 60% IN PLASTIC CONTAINER 60GM/100ML INJECTABLE / INJECTION 1991-07-02 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N020047-003 DEXTROSE 70% IN PLASTIC CONTAINER 70GM/100ML INJECTABLE / INJECTION AP RLD, RS 1991-07-02 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N020047-001 DEXTROSE 50% IN PLASTIC CONTAINER 50GM/100ML INJECTABLE / INJECTION AP RLD, RS 1991-07-02 5aa47cf7b7d7…2021-03-12 10:30 UTC 2021-03 N020047-002 DEXTROSE 60% IN PLASTIC CONTAINER 60GM/100ML INJECTABLE / INJECTION 1991-07-02 5aa47cf7b7d7…2021-03-12 10:30 UTC 2021-03 N020047-003 DEXTROSE 70% IN PLASTIC CONTAINER 70GM/100ML INJECTABLE / INJECTION AP RLD, RS 1991-07-02 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N020047-001 DEXTROSE 50% IN PLASTIC CONTAINER 50GM/100ML INJECTABLE / INJECTION AP RLD, RS 1991-07-02 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 N020047-002 DEXTROSE 60% IN PLASTIC CONTAINER 60GM/100ML INJECTABLE / INJECTION 1991-07-02 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 N020047-003 DEXTROSE 70% IN PLASTIC CONTAINER 70GM/100ML INJECTABLE / INJECTION AP RLD, RS 1991-07-02 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N020047-001 DEXTROSE 50% IN PLASTIC CONTAINER 50GM/100ML INJECTABLE / INJECTION AP RLD, RS 1991-07-02 c0c555d07b60…2020-11-12 02:37 UTC 2020-11 N020047-002 DEXTROSE 60% IN PLASTIC CONTAINER 60GM/100ML INJECTABLE / INJECTION 1991-07-02 c0c555d07b60…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 88 observed states.
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 · 1 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join DEXTROSE DEXTROSE MONOHYDRATE Baxter Healthcare Corporation 0332f34a-7038-47cc-ba59-d55cad6b73ca 2019-08-05 Warnings, Adverse reactions Exact identifier application applno (NDA): 020047 application number: NDA020047 ndc (product): 0338-0719
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 · 6 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0338-0719 DEXTROSE Dextrose monohydrate Baxter Healthcare Corporation NDA Current 0338-0719 DEXTROSE Dextrose monohydrate Baxter Healthcare Corporation NDA Current 0338-0719 DEXTROSE Dextrose monohydrate Baxter Healthcare Corporation NDA Current 0338-0719 DEXTROSE Dextrose monohydrate Baxter Healthcare Corporation NDA Current 0338-0719 DEXTROSE Dextrose monohydrate Baxter Healthcare Corporation NDA Current 0338-0719 DEXTROSE Dextrose monohydrate Baxter Healthcare Corporation NDA Current
Documents# Document, Submission type, Date table Document Submission type Date 59601 SUPPL 2019-08-06 59586 SUPPL 2019-08-06 12161 SUPPL 2015-01-09 1949 SUPPL 2014-12-24