Home Applications 017651 Application 017651
Type NDA
Sponsor FRESENIUS KABI USA Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 003 HEPARIN SODIUM HEPARIN SODIUM INJECTABLE;INJECTION 10,000 UNITS/ML No No 005 HEPARIN SODIUM HEPARIN SODIUM INJECTABLE;INJECTION 1,000 UNITS/ML No No 006 HEPARIN SODIUM HEPARIN SODIUM INJECTABLE;INJECTION 5,000 UNITS/ML Yes Yes 008 HEPARIN SODIUM HEPARIN SODIUM INJECTABLE;INJECTION 20,000 UNITS/ML No No
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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N017651-003 HEPARIN SODIUM HEPARIN SODIUM 10,000 UNITS/ML INJECTABLE / INJECTION Approved before 1982 N017651-005 HEPARIN SODIUM HEPARIN SODIUM 1,000 UNITS/ML INJECTABLE / INJECTION Approved before 1982 N017651-006 HEPARIN SODIUM HEPARIN SODIUM 5,000 UNITS/ML INJECTABLE / INJECTION AP RLD, RS, Approved before 1982 N017651-008 HEPARIN SODIUM HEPARIN SODIUM 20,000 UNITS/ML INJECTABLE / INJECTION Approved before 1982
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N017651-006 AP
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 5 · 176 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 2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N017651-003 HEPARIN SODIUM 10,000 UNITS/ML INJECTABLE / INJECTION Approved before 1982 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N017651-005 HEPARIN SODIUM 1,000 UNITS/ML INJECTABLE / INJECTION Approved before 1982 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N017651-006 HEPARIN SODIUM 5,000 UNITS/ML INJECTABLE / INJECTION AP RLD, RS, Approved before 1982 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N017651-008 HEPARIN SODIUM 20,000 UNITS/ML INJECTABLE / INJECTION Approved before 1982 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N017651-003 HEPARIN SODIUM 10,000 UNITS/ML INJECTABLE / INJECTION Approved before 1982 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N017651-005 HEPARIN SODIUM 1,000 UNITS/ML INJECTABLE / INJECTION Approved before 1982 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N017651-006 HEPARIN SODIUM 5,000 UNITS/ML INJECTABLE / INJECTION AP RLD, RS, Approved before 1982 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N017651-008 HEPARIN SODIUM 20,000 UNITS/ML INJECTABLE / INJECTION Approved before 1982 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N017651-003 HEPARIN SODIUM 10,000 UNITS/ML INJECTABLE / INJECTION Approved before 1982 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N017651-005 HEPARIN SODIUM 1,000 UNITS/ML INJECTABLE / INJECTION Approved before 1982 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N017651-006 HEPARIN SODIUM 5,000 UNITS/ML INJECTABLE / INJECTION AP RLD, RS, Approved before 1982 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N017651-008 HEPARIN SODIUM 20,000 UNITS/ML INJECTABLE / INJECTION Approved before 1982 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N017651-003 HEPARIN SODIUM 10,000 UNITS/ML INJECTABLE / INJECTION Approved before 1982 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N017651-005 HEPARIN SODIUM 1,000 UNITS/ML INJECTABLE / INJECTION Approved before 1982 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N017651-006 HEPARIN SODIUM 5,000 UNITS/ML INJECTABLE / INJECTION AP RLD, RS, Approved before 1982 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N017651-008 HEPARIN SODIUM 20,000 UNITS/ML INJECTABLE / INJECTION Approved before 1982 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N017651-003 HEPARIN SODIUM 10,000 UNITS/ML INJECTABLE / INJECTION Approved before 1982 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N017651-005 HEPARIN SODIUM 1,000 UNITS/ML INJECTABLE / INJECTION Approved before 1982 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N017651-006 HEPARIN SODIUM 5,000 UNITS/ML INJECTABLE / INJECTION AP RLD, RS, Approved before 1982 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N017651-008 HEPARIN SODIUM 20,000 UNITS/ML INJECTABLE / INJECTION Approved before 1982 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N017651-003 HEPARIN SODIUM 10,000 UNITS/ML INJECTABLE / INJECTION Approved before 1982 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N017651-005 HEPARIN SODIUM 1,000 UNITS/ML INJECTABLE / INJECTION Approved before 1982 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N017651-006 HEPARIN SODIUM 5,000 UNITS/ML INJECTABLE / INJECTION AP RLD, RS, Approved before 1982 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N017651-008 HEPARIN SODIUM 20,000 UNITS/ML INJECTABLE / INJECTION Approved before 1982 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N017651-003 HEPARIN SODIUM 10,000 UNITS/ML INJECTABLE / INJECTION Approved before 1982 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N017651-005 HEPARIN SODIUM 1,000 UNITS/ML INJECTABLE / INJECTION Approved before 1982 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N017651-006 HEPARIN SODIUM 5,000 UNITS/ML INJECTABLE / INJECTION AP RLD, RS, Approved before 1982 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N017651-008 HEPARIN SODIUM 20,000 UNITS/ML INJECTABLE / INJECTION Approved before 1982 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N017651-003 HEPARIN SODIUM 10,000 UNITS/ML INJECTABLE / INJECTION Approved before 1982 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N017651-005 HEPARIN SODIUM 1,000 UNITS/ML INJECTABLE / INJECTION Approved before 1982 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N017651-006 HEPARIN SODIUM 5,000 UNITS/ML INJECTABLE / INJECTION AP RLD, RS, Approved before 1982 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N017651-008 HEPARIN SODIUM 20,000 UNITS/ML INJECTABLE / INJECTION Approved before 1982 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N017651-003 HEPARIN SODIUM 10,000 UNITS/ML INJECTABLE / INJECTION Approved before 1982 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N017651-005 HEPARIN SODIUM 1,000 UNITS/ML INJECTABLE / INJECTION Approved before 1982 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N017651-006 HEPARIN SODIUM 5,000 UNITS/ML INJECTABLE / INJECTION AP RLD, RS, Approved before 1982 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N017651-008 HEPARIN SODIUM 20,000 UNITS/ML INJECTABLE / INJECTION Approved before 1982 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N017651-003 HEPARIN SODIUM 10,000 UNITS/ML INJECTABLE / INJECTION Approved before 1982 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N017651-005 HEPARIN SODIUM 1,000 UNITS/ML INJECTABLE / INJECTION Approved before 1982 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N017651-006 HEPARIN SODIUM 5,000 UNITS/ML INJECTABLE / INJECTION AP RLD, RS, Approved before 1982 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N017651-008 HEPARIN SODIUM 20,000 UNITS/ML INJECTABLE / INJECTION Approved before 1982 4b0b4de00fa7…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 44 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.
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 · 3 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 63323-047 Heparin Sodium HEPARIN SODIUM Fresenius Kabi USA, LLC NDA Current 63323-047 Heparin Sodium HEPARIN SODIUM Fresenius Kabi USA, LLC NDA Current 63323-047 Heparin Sodium HEPARIN SODIUM Fresenius Kabi USA, LLC NDA Current
Documents# Document, Submission type, Date table Document Submission type Date 80008 SUPPL 2024-10-28 79994 SUPPL 2024-10-25 67736 SUPPL 2021-06-08 63805 SUPPL 2020-07-06 63796 SUPPL 2020-07-06 677 SUPPL 2014-04-07 676 SUPPL 2011-12-29 33328 SUPPL 2011-12-23 675 SUPPL 2011-07-05 11051 SUPPL 2010-06-24 13878 SUPPL 2010-06-14 33327 SUPPL 2009-04-03 674 SUPPL 2009-04-03 13877 SUPPL 2008-01-09 20081 ORIG 2007-07-20