Application 087906

Type
ANDA
Sponsor
SMITH AND NEPHEW

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001HEPARIN LOCK FLUSHHEPARIN SODIUMINJECTABLE;INJECTION100 UNITS/MLNoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A087906-001HEPARIN LOCK FLUSHHEPARIN SODIUM100 UNITS/MLINJECTABLE / INJECTION1983-04-20

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 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A087906-001HEPARIN LOCK FLUSH100 UNITS/MLINJECTABLE / INJECTION1983-04-2084e616aacf4f…
2026-08-18 06:07:402026-07A087906-001HEPARIN LOCK FLUSH100 UNITS/MLINJECTABLE / INJECTION1983-04-20caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A087906-001HEPARIN LOCK FLUSH100 UNITS/MLINJECTABLE / INJECTION1983-04-20011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A087906-001HEPARIN LOCK FLUSH100 UNITS/MLINJECTABLE / INJECTION1983-04-2031067a03dcf5…
2025-08-23 18:47 UTC2025-08A087906-001HEPARIN LOCK FLUSH100 UNITS/MLINJECTABLE / INJECTION1983-04-206a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A087906-001HEPARIN LOCK FLUSH100 UNITS/MLINJECTABLE / INJECTION1983-04-20fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A087906-001HEPARIN LOCK FLUSH100 UNITS/MLINJECTABLE / INJECTION1983-04-20b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A087906-001HEPARIN LOCK FLUSH100 UNITS/MLINJECTABLE / INJECTION1983-04-2003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A087906-001HEPARIN LOCK FLUSH100 UNITS/MLINJECTABLE / INJECTION1983-04-202680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A087906-001HEPARIN LOCK FLUSH100 UNITS/MLINJECTABLE / INJECTION1983-04-205bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A087906-001HEPARIN LOCK FLUSH100 UNITS/MLINJECTABLE / INJECTION1983-04-20d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A087906-001HEPARIN LOCK FLUSH100 UNITS/MLINJECTABLE / INJECTION1983-04-20d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A087906-001HEPARIN LOCK FLUSH100 UNITS/MLINJECTABLE / INJECTION1983-04-2079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A087906-001HEPARIN LOCK FLUSH100 UNITS/MLINJECTABLE / INJECTION1983-04-20301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A087906-001HEPARIN LOCK FLUSH100 UNITS/MLINJECTABLE / INJECTION1983-04-201e350fbaab3a…
2024-05-31 18:47 UTC2024-05A087906-001HEPARIN LOCK FLUSH100 UNITS/MLINJECTABLE / INJECTION1983-04-208072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A087906-001HEPARIN LOCK FLUSH100 UNITS/MLINJECTABLE / INJECTION1983-04-205c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A087906-001HEPARIN LOCK FLUSH100 UNITS/MLINJECTABLE / INJECTION1983-04-205d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A087906-001HEPARIN LOCK FLUSH100 UNITS/MLINJECTABLE / INJECTION1983-04-204b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A087906-001HEPARIN LOCK FLUSH100 UNITS/MLINJECTABLE / INJECTION1983-04-2074a2ff9319b5…
2022-03-09 01:35 UTC2022-03A087906-001HEPARIN LOCK FLUSH100 UNITS/MLINJECTABLE / INJECTION1983-04-20bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A087906-001HEPARIN LOCK FLUSH100 UNITS/MLINJECTABLE / INJECTION1983-04-20782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A087906-001HEPARIN LOCK FLUSH100 UNITS/MLINJECTABLE / INJECTION1983-04-2087673890dc5c…
2021-03-12 10:30 UTC2021-03A087906-001HEPARIN LOCK FLUSH100 UNITS/MLINJECTABLE / INJECTION1983-04-205aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A087906-001HEPARIN LOCK FLUSH100 UNITS/MLINJECTABLE / INJECTION1983-04-208869cabd3fbd…
2020-11-12 02:37 UTC2020-11A087906-001HEPARIN LOCK FLUSH100 UNITS/MLINJECTABLE / INJECTION1983-04-20c0c555d07b60…
2019-12-14 00:12 UTC2019-12A087906-001HEPARIN LOCK FLUSH100 UNITS/MLINJECTABLE / INJECTION1983-04-203f01610625f2…
2019-09-15 20:21 UTC2019-09A087906-001HEPARIN LOCK FLUSH100 UNITS/MLINJECTABLE / INJECTION1983-04-20b00525d2431f…
2019-07-19 19:46 UTC2019-07A087906-001HEPARIN LOCK FLUSH100 UNITS/MLINJECTABLE / INJECTION1983-04-20ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A087906-001HEPARIN LOCK FLUSH100 UNITS/MLINJECTABLE / INJECTION1983-04-206a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A087906-001HEPARIN LOCK FLUSH100 UNITS/MLINJECTABLE / INJECTION1983-04-201c564ffb4f44…
2023-12-20 04:57 UTC2023-12A087906-001HEPARIN LOCK FLUSH100 UNITS/MLINJECTABLE / INJECTION1983-04-20ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A087906-001HEPARIN LOCK FLUSH100 UNITS/MLINJECTABLE / INJECTION1983-04-20a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A087906-001HEPARIN LOCK FLUSH100 UNITS/MLINJECTABLE / INJECTION1983-04-209b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A087906-001HEPARIN LOCK FLUSH100 UNITS/MLINJECTABLE / INJECTION1983-04-20a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A087906-001HEPARIN LOCK FLUSH100 UNITS/MLINJECTABLE / INJECTION1983-04-203f0d92c62455…
2023-05-13 08:27 UTC2023-05A087906-001HEPARIN LOCK FLUSH100 UNITS/MLINJECTABLE / INJECTION1983-04-20053a50430f4f…
2023-01-26 05:58 UTC2023-01A087906-001HEPARIN LOCK FLUSH100 UNITS/MLINJECTABLE / INJECTION1983-04-203bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A087906-001HEPARIN LOCK FLUSH100 UNITS/MLINJECTABLE / INJECTION1983-04-203a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A087906-001HEPARIN LOCK FLUSH100 UNITS/MLINJECTABLE / INJECTION1983-04-20f41ea6bd6efb…

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 3 of 3 · 57 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Heparin SodiumHEPARIN SODIUMNorthstar Rx LLC2edf6d35-5cf3-b7ff-e063-6394a90a4f332025-02-19Warnings, Adverse reactionsName fallback
generic name: HEPARIN SODIUM
Heparin SodiumHEPARIN SODIUMSandoz Inc.1c634e53-44d6-cdcd-e063-6294a90a92e92025-02-19Warnings, Adverse reactionsName fallback
generic name: HEPARIN SODIUM
Heparin SodiumHEPARIN SODIUMMeitheal Pharmaceuticals Inc.7df6c90c-3b55-4bb6-8a72-6e6a6aca4e7c2025-02-04Warnings, Adverse reactionsName fallback
generic name: HEPARIN SODIUM
Heparin SodiumHEPARIN SODIUMMeitheal Pharmaceuticals Inc.57f1ec87-8a7d-41da-b8b8-9ecc8601c60f2025-01-22Warnings, Adverse reactionsName fallback
generic name: HEPARIN SODIUM
Heparin SodiumHEPARIN SODIUMMcKesson Corporation dba SKY Packaging7f05762a-7527-4796-b21e-68277aec379e2025-01-21Warnings, Adverse reactionsName fallback
generic name: HEPARIN SODIUM
HEPARIN SODIUMHEPARIN SODIUMHF Acquisition Co LLC, DBA HealthFirst9bd0f982-30f4-4e38-e053-2a95a90a3e152025-01-08Warnings, Adverse reactionsName fallback
generic name: HEPARIN SODIUM
HEPARIN SODIUMHEPARIN SODIUMHF Acquisition Co LLC, DBA HealthFirst9a5549ae-527a-1b83-e053-2a95a90a133d2025-01-08Warnings, Adverse reactionsName fallback
generic name: HEPARIN SODIUM
Heparin SodiumHEPARIN SODIUMMeitheal Pharmaceuticals Inc.ad0f410c-6121-43f9-9844-943472961cb02025-01-08Warnings, Adverse reactionsName fallback
generic name: HEPARIN SODIUM
Heparin SodiumHEPARIN SODIUMBE Pharmaceuticals Inc.295ea9c6-d08c-40f0-a908-de0fdac446442024-10-30Warnings, Adverse reactionsName fallback
generic name: HEPARIN SODIUM
Heparin SodiumHEPARIN SODIUMBE Pharmaceuticals Inc.6be171fb-c85f-4336-a88d-b4d97bb0fe032024-10-30Warnings, Adverse reactionsName fallback
generic name: HEPARIN SODIUM
Heparin SodiumHEPARIN SODIUMPhlow Corporationcece935c-1c0a-4949-b023-d6df3d53fbfa2024-05-16Warnings, Adverse reactionsName fallback
generic name: HEPARIN SODIUM
Heparin SodiumHEPARIN SODIUMFresenius Kabi USA, LLC25b0ba06-3274-4a3f-8c39-42d13764ecdf2024-04-30Warnings, Adverse reactionsName fallback
generic name: HEPARIN SODIUM
Heparin SodiumHEPARIN SODIUMFresenius Kabi USA, LLCcb1c1e7a-c9ca-4a07-8833-e45ce436d2872024-04-30Warnings, Adverse reactionsName fallback
generic name: HEPARIN SODIUM
HEPARIN SODIUMHEPARIN SODIUMHF Acquisition Co LLC, DBA HealthFirst971505d4-f78c-6f5d-e053-2995a90a00e02024-01-29Warnings, Adverse reactionsName fallback
generic name: HEPARIN SODIUM
Heparin SodiumHEPARIN SODIUMFresenius Kabi USA, LLCa120bdfd-21e1-4024-82a7-13cfeed290c12024-01-05Warnings, Adverse reactionsName fallback
generic name: HEPARIN SODIUM
HEPARIN SODIUM IN SODIUM CHLORIDEHEPARIN SODIUMBaxter Healthcare Corporation0d929726-76c3-48fc-b4e7-fd06409f9fb32022-01-03Warnings, Adverse reactionsName fallback
generic name: HEPARIN SODIUM
Heparin SodiumHEPARIN SODIUMFresenius Kabi USA, LLC3facd525-b9ad-46d0-b63e-f13a5f6d591d2021-09-01Warnings, Adverse reactionsName fallback
generic name: HEPARIN SODIUM

Reported adverse events (FAERS/openFDA)#

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