Application 211007

Type: ANDA
Sponsor: NANJING KING-FRIEND

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	HEPARIN SODIUM	HEPARIN SODIUM	INJECTABLE;INJECTION	1,000 UNITS/ML	No	No
002	HEPARIN SODIUM	HEPARIN SODIUM	INJECTABLE;INJECTION	5,000 UNITS/ML	No	No
003	HEPARIN SODIUM	HEPARIN SODIUM	INJECTABLE;INJECTION	10,000 UNITS/ML	No	No

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

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	Approval date
A211007-001	HEPARIN SODIUM	HEPARIN SODIUM	1,000 UNITS/ML	INJECTABLE / INJECTION	AP	2019-05-28
A211007-002	HEPARIN SODIUM	HEPARIN SODIUM	5,000 UNITS/ML	INJECTABLE / INJECTION	AP	2019-05-28
A211007-003	HEPARIN SODIUM	HEPARIN SODIUM	10,000 UNITS/ML	INJECTABLE / INJECTION	AP	2019-05-28

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A211007-001	AP
A211007-002	AP
A211007-003	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 1 of 4 · 129 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A211007-001	HEPARIN SODIUM	1,000 UNITS/ML	INJECTABLE / INJECTION	AP	2019-05-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A211007-002	HEPARIN SODIUM	5,000 UNITS/ML	INJECTABLE / INJECTION	AP	2019-05-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A211007-003	HEPARIN SODIUM	10,000 UNITS/ML	INJECTABLE / INJECTION	AP	2019-05-28	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A211007-001	HEPARIN SODIUM	1,000 UNITS/ML	INJECTABLE / INJECTION	AP	2019-05-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211007-002	HEPARIN SODIUM	5,000 UNITS/ML	INJECTABLE / INJECTION	AP	2019-05-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211007-003	HEPARIN SODIUM	10,000 UNITS/ML	INJECTABLE / INJECTION	AP	2019-05-28	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A211007-001	HEPARIN SODIUM	1,000 UNITS/ML	INJECTABLE / INJECTION	AP	2019-05-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211007-002	HEPARIN SODIUM	5,000 UNITS/ML	INJECTABLE / INJECTION	AP	2019-05-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211007-003	HEPARIN SODIUM	10,000 UNITS/ML	INJECTABLE / INJECTION	AP	2019-05-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211007-001	HEPARIN SODIUM	1,000 UNITS/ML	INJECTABLE / INJECTION	AP	2019-05-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211007-002	HEPARIN SODIUM	5,000 UNITS/ML	INJECTABLE / INJECTION	AP	2019-05-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211007-003	HEPARIN SODIUM	10,000 UNITS/ML	INJECTABLE / INJECTION	AP	2019-05-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211007-001	HEPARIN SODIUM	1,000 UNITS/ML	INJECTABLE / INJECTION	AP	2019-05-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211007-002	HEPARIN SODIUM	5,000 UNITS/ML	INJECTABLE / INJECTION	AP	2019-05-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211007-003	HEPARIN SODIUM	10,000 UNITS/ML	INJECTABLE / INJECTION	AP	2019-05-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211007-001	HEPARIN SODIUM	1,000 UNITS/ML	INJECTABLE / INJECTION	AP	2019-05-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211007-002	HEPARIN SODIUM	5,000 UNITS/ML	INJECTABLE / INJECTION	AP	2019-05-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211007-003	HEPARIN SODIUM	10,000 UNITS/ML	INJECTABLE / INJECTION	AP	2019-05-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211007-001	HEPARIN SODIUM	1,000 UNITS/ML	INJECTABLE / INJECTION	AP	2019-05-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211007-002	HEPARIN SODIUM	5,000 UNITS/ML	INJECTABLE / INJECTION	AP	2019-05-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211007-003	HEPARIN SODIUM	10,000 UNITS/ML	INJECTABLE / INJECTION	AP	2019-05-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211007-001	HEPARIN SODIUM	1,000 UNITS/ML	INJECTABLE / INJECTION	AP	2019-05-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211007-002	HEPARIN SODIUM	5,000 UNITS/ML	INJECTABLE / INJECTION	AP	2019-05-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211007-003	HEPARIN SODIUM	10,000 UNITS/ML	INJECTABLE / INJECTION	AP	2019-05-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211007-001	HEPARIN SODIUM	1,000 UNITS/ML	INJECTABLE / INJECTION	AP	2019-05-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211007-002	HEPARIN SODIUM	5,000 UNITS/ML	INJECTABLE / INJECTION	AP	2019-05-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211007-003	HEPARIN SODIUM	10,000 UNITS/ML	INJECTABLE / INJECTION	AP	2019-05-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211007-001	HEPARIN SODIUM	1,000 UNITS/ML	INJECTABLE / INJECTION	AP	2019-05-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211007-002	HEPARIN SODIUM	5,000 UNITS/ML	INJECTABLE / INJECTION	AP	2019-05-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211007-003	HEPARIN SODIUM	10,000 UNITS/ML	INJECTABLE / INJECTION	AP	2019-05-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211007-001	HEPARIN SODIUM	1,000 UNITS/ML	INJECTABLE / INJECTION	AP	2019-05-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211007-002	HEPARIN SODIUM	5,000 UNITS/ML	INJECTABLE / INJECTION	AP	2019-05-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211007-003	HEPARIN SODIUM	10,000 UNITS/ML	INJECTABLE / INJECTION	AP	2019-05-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211007-001	HEPARIN SODIUM	1,000 UNITS/ML	INJECTABLE / INJECTION	AP	2019-05-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A211007-002	HEPARIN SODIUM	5,000 UNITS/ML	INJECTABLE / INJECTION	AP	2019-05-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A211007-003	HEPARIN SODIUM	10,000 UNITS/ML	INJECTABLE / INJECTION	AP	2019-05-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211007-001	HEPARIN SODIUM	1,000 UNITS/ML	INJECTABLE / INJECTION	AP	2019-05-28	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211007-002	HEPARIN SODIUM	5,000 UNITS/ML	INJECTABLE / INJECTION	AP	2019-05-28	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211007-003	HEPARIN SODIUM	10,000 UNITS/ML	INJECTABLE / INJECTION	AP	2019-05-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211007-001	HEPARIN SODIUM	1,000 UNITS/ML	INJECTABLE / INJECTION	AP	2019-05-28	`301d65b070ca…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 129 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A211007-001	AP	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A211007-002	AP	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A211007-003	AP	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A211007-001	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211007-002	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211007-003	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A211007-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211007-002	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211007-003	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211007-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211007-002	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211007-003	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211007-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211007-002	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211007-003	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211007-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211007-002	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211007-003	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211007-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211007-002	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211007-003	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211007-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211007-002	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211007-003	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211007-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211007-002	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211007-003	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211007-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211007-002	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211007-003	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211007-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211007-002	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211007-003	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211007-001	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A211007-002	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A211007-003	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211007-001	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211007-002	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211007-003	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211007-001	AP	1	`301d65b070ca…`

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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Heparin Sodium	HEPARIN SODIUM	Meitheal Pharmaceuticals Inc.	02fb700d-a28c-4d45-b78d-382dc0d5986c	2025-09-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211007 application number: ANDA211007 ndc (product): 71288-403 ndc (product): 71288-402 ndc (product): 71288-404
Heparin Sodium	HEPARIN SODIUM	Medical Purchasing Solutions, LLC	3edf9198-b88d-7808-e063-6394a90ae89c	2025-09-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211007 application number: ANDA211007
Heparin Sodium	HEPARIN SODIUM	Medical Purchasing Solutions, LLC.	3ea2bd53-ed13-a516-e063-6394a90a5dd9	2025-09-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211007 application number: ANDA211007
Heparin Sodium	HEPARIN SODIUM	NorthStar RxLLC	c4fa6d34-e76b-4c3c-b74d-21ce41432a04	2025-05-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211007 application number: ANDA211007

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 23 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
71288-402	Heparin Sodium	Heparin Sodium	Meitheal Pharmaceuticals Inc.	ANDA	Current
71288-402	Heparin Sodium	Heparin Sodium	Meitheal Pharmaceuticals Inc.	ANDA	Current
71288-402	Heparin Sodium	Heparin Sodium	Meitheal Pharmaceuticals Inc.	ANDA	Current
71288-403	Heparin Sodium	Heparin Sodium	Meitheal Pharmaceuticals Inc.	ANDA	Current
71288-403	Heparin Sodium	Heparin Sodium	Meitheal Pharmaceuticals Inc.	ANDA	Current
71288-403	Heparin Sodium	Heparin Sodium	Meitheal Pharmaceuticals Inc.	ANDA	Current
71288-404	Heparin Sodium	Heparin Sodium	Meitheal Pharmaceuticals Inc.	ANDA	Current
71288-404	Heparin Sodium	Heparin Sodium	Meitheal Pharmaceuticals Inc.	ANDA	Current
71288-404	Heparin Sodium	Heparin Sodium	Meitheal Pharmaceuticals Inc.	ANDA	Current
71288-419	Heparin Sodium	Heparin Sodium	Meitheal Pharmaceuticals Inc.	ANDA	Current
71288-419	Heparin Sodium	Heparin Sodium	Meitheal Pharmaceuticals Inc.	ANDA	Current
71288-420	Heparin Sodium	Heparin Sodium	Meitheal Pharmaceuticals Inc.	ANDA	Current
71288-420	Heparin Sodium	Heparin Sodium	Meitheal Pharmaceuticals Inc.	ANDA	Current
71288-421	Heparin Sodium	Heparin Sodium	Meitheal Pharmaceuticals Inc.	ANDA	Current
71288-421	Heparin Sodium	Heparin Sodium	Meitheal Pharmaceuticals Inc.	ANDA	Current
71288-422	Heparin Sodium	Heparin Sodium	Meitheal Pharmaceuticals Inc.	ANDA	Current
71288-422	Heparin Sodium	Heparin Sodium	Meitheal Pharmaceuticals Inc.	ANDA	Current
71288-423	Heparin Sodium	Heparin Sodium	Meitheal Pharmaceuticals Inc.	ANDA	Current
71288-423	Heparin Sodium	Heparin Sodium	Meitheal Pharmaceuticals Inc.	ANDA	Current
71288-424	Heparin Sodium	Heparin Sodium	Meitheal Pharmaceuticals Inc.	ANDA	Current
71288-424	Heparin Sodium	Heparin Sodium	Meitheal Pharmaceuticals Inc.	ANDA	Current
71288-425	Heparin Sodium	Heparin Sodium	Meitheal Pharmaceuticals Inc.	ANDA	Current
71288-425	Heparin Sodium	Heparin Sodium	Meitheal Pharmaceuticals Inc.	ANDA	Current