Application 212061

Type
ANDA
Sponsor
NANJING KING-FRIEND

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001HEPARIN SODIUMHEPARIN SODIUMINJECTABLE;INJECTION5,000 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
A212061-001HEPARIN SODIUMHEPARIN SODIUM5,000 UNITS/MLINJECTABLE / INJECTIONAP2020-07-15

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
A212061-001AP

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 table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A212061-001HEPARIN SODIUM5,000 UNITS/MLINJECTABLE / INJECTIONAP2020-07-1584e616aacf4f…
2026-08-18 06:07:402026-07A212061-001HEPARIN SODIUM5,000 UNITS/MLINJECTABLE / INJECTIONAP2020-07-15caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A212061-001HEPARIN SODIUM5,000 UNITS/MLINJECTABLE / INJECTIONAP2020-07-15011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A212061-001HEPARIN SODIUM5,000 UNITS/MLINJECTABLE / INJECTIONAP2020-07-1531067a03dcf5…
2025-08-23 18:47 UTC2025-08A212061-001HEPARIN SODIUM5,000 UNITS/MLINJECTABLE / INJECTIONAP2020-07-156a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A212061-001HEPARIN SODIUM5,000 UNITS/MLINJECTABLE / INJECTIONAP2020-07-15fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A212061-001HEPARIN SODIUM5,000 UNITS/MLINJECTABLE / INJECTIONAP2020-07-15b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A212061-001HEPARIN SODIUM5,000 UNITS/MLINJECTABLE / INJECTIONAP2020-07-1503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A212061-001HEPARIN SODIUM5,000 UNITS/MLINJECTABLE / INJECTIONAP2020-07-152680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A212061-001HEPARIN SODIUM5,000 UNITS/MLINJECTABLE / INJECTIONAP2020-07-155bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A212061-001HEPARIN SODIUM5,000 UNITS/MLINJECTABLE / INJECTIONAP2020-07-15d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A212061-001HEPARIN SODIUM5,000 UNITS/MLINJECTABLE / INJECTIONAP2020-07-15d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A212061-001HEPARIN SODIUM5,000 UNITS/MLINJECTABLE / INJECTIONAP2020-07-1579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A212061-001HEPARIN SODIUM5,000 UNITS/MLINJECTABLE / INJECTIONAP2020-07-15301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A212061-001HEPARIN SODIUM5,000 UNITS/MLINJECTABLE / INJECTIONAP2020-07-151e350fbaab3a…
2024-05-31 18:47 UTC2024-05A212061-001HEPARIN SODIUM5,000 UNITS/MLINJECTABLE / INJECTIONAP2020-07-158072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A212061-001HEPARIN SODIUM5,000 UNITS/MLINJECTABLE / INJECTION2020-07-155c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A212061-001HEPARIN SODIUM5,000 UNITS/MLINJECTABLE / INJECTION2020-07-155d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A212061-001HEPARIN SODIUM5,000 UNITS/MLINJECTABLE / INJECTION2020-07-154b0b4de00fa7…
2022-03-09 01:35 UTC2022-03A212061-001HEPARIN SODIUM5,000 UNITS/MLINJECTABLE / INJECTION2020-07-15bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A212061-001HEPARIN SODIUM5,000 UNITS/MLINJECTABLE / INJECTION2020-07-15782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A212061-001HEPARIN SODIUM5,000 UNITS/MLINJECTABLE / INJECTIONAP2020-07-1587673890dc5c…
2021-03-12 10:30 UTC2021-03A212061-001HEPARIN SODIUM5,000 UNITS/MLINJECTABLE / INJECTIONAP2020-07-155aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A212061-001HEPARIN SODIUM5,000 UNITS/MLINJECTABLE / INJECTIONAP2020-07-158869cabd3fbd…
2020-11-12 02:37 UTC2020-11A212061-001HEPARIN SODIUM5,000 UNITS/MLINJECTABLE / INJECTIONAP2020-07-15c0c555d07b60…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A212061-001HEPARIN SODIUM5,000 UNITS/MLINJECTABLE / INJECTIONAP2020-07-156a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A212061-001HEPARIN SODIUM5,000 UNITS/MLINJECTABLE / INJECTIONAP2020-07-151c564ffb4f44…
2023-12-20 04:57 UTC2023-12A212061-001HEPARIN SODIUM5,000 UNITS/MLINJECTABLE / INJECTIONAP2020-07-15ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A212061-001HEPARIN SODIUM5,000 UNITS/MLINJECTABLE / INJECTIONAP2020-07-15a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A212061-001HEPARIN SODIUM5,000 UNITS/MLINJECTABLE / INJECTIONAP2020-07-159b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A212061-001HEPARIN SODIUM5,000 UNITS/MLINJECTABLE / INJECTIONAP2020-07-15a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A212061-001HEPARIN SODIUM5,000 UNITS/MLINJECTABLE / INJECTIONAP2020-07-153f0d92c62455…
2023-05-13 08:27 UTC2023-05A212061-001HEPARIN SODIUM5,000 UNITS/MLINJECTABLE / INJECTIONAP2020-07-15053a50430f4f…
2023-01-26 05:58 UTC2023-01A212061-001HEPARIN SODIUM5,000 UNITS/MLINJECTABLE / INJECTION2020-07-153bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A212061-001HEPARIN SODIUM5,000 UNITS/MLINJECTABLE / INJECTION2020-07-153a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A212061-001HEPARIN SODIUM5,000 UNITS/MLINJECTABLE / INJECTION2020-07-15f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A212061-001HEPARIN SODIUM5,000 UNITS/MLINJECTABLE / INJECTION2020-07-15e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A212061-001HEPARIN SODIUM5,000 UNITS/MLINJECTABLE / INJECTION2020-07-15cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A212061-001HEPARIN SODIUM5,000 UNITS/MLINJECTABLE / INJECTIONAP2020-07-15a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A212061-001AP184e616aacf4f…
2026-08-18 06:07:402026-07A212061-001AP1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A212061-001AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A212061-001AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08A212061-001AP16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A212061-001AP1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A212061-001AP1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A212061-001AP103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A212061-001AP12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A212061-001AP15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A212061-001AP1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A212061-001AP1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A212061-001AP179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A212061-001AP1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A212061-001AP11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A212061-001AP18072bd15b7f6…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A212061-001AP187673890dc5c…
2021-03-12 10:30 UTC2021-03A212061-001AP15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A212061-001AP18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A212061-001AP1c0c555d07b60…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A212061-001AP16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A212061-001AP11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A212061-001AP1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A212061-001AP1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A212061-001AP19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A212061-001AP1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A212061-001AP13f0d92c62455…
2023-05-13 08:27 UTC2023-05A212061-001AP1053a50430f4f…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A212061-001AP1a50c72e98297…

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Heparin SodiumHEPARIN SODIUMMeitheal Pharmaceuticals Inc.57f1ec87-8a7d-41da-b8b8-9ecc8601c60f2025-01-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212061
application number: ANDA212061
ndc (product): 71288-406

NDC Listings For This Application#

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

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
71288-406Heparin SodiumHeparin SodiumMeitheal Pharmaceuticals Inc.ANDACurrent