Application 202957

Type: ANDA
Sponsor: SHENZHEN TECHDOW

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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A202957-001	HEPARIN SODIUM	HEPARIN SODIUM	1,000 UNITS/ML	INJECTABLE / INJECTION	AP		2014-06-12
A202957-002	HEPARIN SODIUM	HEPARIN SODIUM	5,000 UNITS/ML	INJECTABLE / INJECTION	AP		2014-06-12

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A202957-001	AP
A202957-002	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 3 · 82 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
2026-02-19 14:30 UTC	2026-02	A202957-001	HEPARIN SODIUM	1,000 UNITS/ML	INJECTABLE / INJECTION	AP	2014-06-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202957-002	HEPARIN SODIUM	5,000 UNITS/ML	INJECTABLE / INJECTION	AP	2014-06-12	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202957-001	HEPARIN SODIUM	1,000 UNITS/ML	INJECTABLE / INJECTION	AP	2014-06-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202957-002	HEPARIN SODIUM	5,000 UNITS/ML	INJECTABLE / INJECTION	AP	2014-06-12	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202957-001	HEPARIN SODIUM	1,000 UNITS/ML	INJECTABLE / INJECTION	AP	2014-06-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202957-002	HEPARIN SODIUM	5,000 UNITS/ML	INJECTABLE / INJECTION	AP	2014-06-12	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202957-001	HEPARIN SODIUM	1,000 UNITS/ML	INJECTABLE / INJECTION	AP	2014-06-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202957-002	HEPARIN SODIUM	5,000 UNITS/ML	INJECTABLE / INJECTION	AP	2014-06-12	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202957-001	HEPARIN SODIUM	1,000 UNITS/ML	INJECTABLE / INJECTION	AP	2014-06-12	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202957-002	HEPARIN SODIUM	5,000 UNITS/ML	INJECTABLE / INJECTION	AP	2014-06-12	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202957-001	HEPARIN SODIUM	1,000 UNITS/ML	INJECTABLE / INJECTION	AP	2014-06-12	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202957-002	HEPARIN SODIUM	5,000 UNITS/ML	INJECTABLE / INJECTION	AP	2014-06-12	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202957-001	HEPARIN SODIUM	1,000 UNITS/ML	INJECTABLE / INJECTION	AP	2014-06-12	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202957-002	HEPARIN SODIUM	5,000 UNITS/ML	INJECTABLE / INJECTION	AP	2014-06-12	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202957-001	HEPARIN SODIUM	1,000 UNITS/ML	INJECTABLE / INJECTION	AP	2014-06-12	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202957-002	HEPARIN SODIUM	5,000 UNITS/ML	INJECTABLE / INJECTION	AP	2014-06-12	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202957-001	HEPARIN SODIUM	1,000 UNITS/ML	INJECTABLE / INJECTION	AP	2014-06-12	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202957-002	HEPARIN SODIUM	5,000 UNITS/ML	INJECTABLE / INJECTION	AP	2014-06-12	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202957-001	HEPARIN SODIUM	1,000 UNITS/ML	INJECTABLE / INJECTION	AP	2014-06-12	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202957-002	HEPARIN SODIUM	5,000 UNITS/ML	INJECTABLE / INJECTION	AP	2014-06-12	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202957-001	HEPARIN SODIUM	1,000 UNITS/ML	INJECTABLE / INJECTION	AP	2014-06-12	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202957-002	HEPARIN SODIUM	5,000 UNITS/ML	INJECTABLE / INJECTION	AP	2014-06-12	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202957-001	HEPARIN SODIUM	1,000 UNITS/ML	INJECTABLE / INJECTION	AP	2014-06-12	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202957-002	HEPARIN SODIUM	5,000 UNITS/ML	INJECTABLE / INJECTION	AP	2014-06-12	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202957-001	HEPARIN SODIUM	1,000 UNITS/ML	INJECTABLE / INJECTION	AP	2014-06-12	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202957-002	HEPARIN SODIUM	5,000 UNITS/ML	INJECTABLE / INJECTION	AP	2014-06-12	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202957-001	HEPARIN SODIUM	1,000 UNITS/ML	INJECTABLE / INJECTION	AP	2014-06-12	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A202957-002	HEPARIN SODIUM	5,000 UNITS/ML	INJECTABLE / INJECTION	AP	2014-06-12	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202957-001	HEPARIN SODIUM	1,000 UNITS/ML	INJECTABLE / INJECTION	AP	2014-06-12	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202957-002	HEPARIN SODIUM	5,000 UNITS/ML	INJECTABLE / INJECTION	AP	2014-06-12	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A202957-001	HEPARIN SODIUM	1,000 UNITS/ML	INJECTABLE / INJECTION	AP	2014-06-12	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A202957-002	HEPARIN SODIUM	5,000 UNITS/ML	INJECTABLE / INJECTION	AP	2014-06-12	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A202957-001	HEPARIN SODIUM	1,000 UNITS/ML	INJECTABLE / INJECTION	AP	2014-06-12	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A202957-002	HEPARIN SODIUM	5,000 UNITS/ML	INJECTABLE / INJECTION	AP	2014-06-12	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A202957-001	HEPARIN SODIUM	1,000 UNITS/ML	INJECTABLE / INJECTION	AP	2014-06-12	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A202957-002	HEPARIN SODIUM	5,000 UNITS/ML	INJECTABLE / INJECTION	AP	2014-06-12	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A202957-001	HEPARIN SODIUM	1,000 UNITS/ML	INJECTABLE / INJECTION	AP	2014-06-12	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A202957-002	HEPARIN SODIUM	5,000 UNITS/ML	INJECTABLE / INJECTION	AP	2014-06-12	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A202957-001	HEPARIN SODIUM	1,000 UNITS/ML	INJECTABLE / INJECTION	AP	2014-06-12	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A202957-002	HEPARIN SODIUM	5,000 UNITS/ML	INJECTABLE / INJECTION	AP	2014-06-12	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A202957-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202957-002	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202957-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202957-002	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202957-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202957-002	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202957-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202957-002	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202957-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202957-002	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202957-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202957-002	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202957-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202957-002	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202957-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202957-002	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202957-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202957-002	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202957-001	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202957-002	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202957-001	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202957-002	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202957-001	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202957-002	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202957-001	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202957-002	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202957-001	AP	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A202957-002	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202957-001	AP	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202957-002	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A202957-001	AP	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A202957-002	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A202957-001	AP	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A202957-002	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A202957-001	AP	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A202957-002	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A202957-001	AP	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A202957-002	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A202957-001	AP	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A202957-002	AP	1	`782e0a99824c…`

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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Heparin Sodium	HEPARIN SODIUM	Medical Purchasing Solutions, LLC	4c118b39-cb4e-31a9-e063-6394a90a41b0	2026-03-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202957 application number: ANDA202957
Heparin Sodium	HEPARIN SODIUM	Hepalink USA Inc.	c4c6bc1f-e0c7-fd0d-e053-2995a90abdef	2025-02-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202957 application number: ANDA202957 ndc (product): 81952-111 ndc (product): 81952-112
Heparin Sodium	HEPARIN SODIUM	Northstar Rx LLC	2edf6d35-5cf3-b7ff-e063-6394a90a4f33	2025-02-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202957 application number: ANDA202957
Heparin Sodium	HEPARIN SODIUM	Sandoz Inc.	1c634e53-44d6-cdcd-e063-6294a90a92e9	2025-02-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202957 application number: ANDA202957
Heparin Sodium	HEPARIN SODIUM	McKesson Corporation dba SKY Packaging	7f05762a-7527-4796-b21e-68277aec379e	2025-01-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202957 application number: ANDA202957 ndc (product): 63739-931 ndc (product): 63739-920 ndc (product): 63739-953 ndc (product): 63739-942

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 34 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
48433-329	Heparin Sodium	Heparin Sodium	Safecor Health, LLC	ANDA	Current
55154-8131	Heparin Sodium	Heparin Sodium	Cardinal Health 107, LLC	ANDA	Current
55154-8131	Heparin Sodium	Heparin Sodium	Cardinal Health	ANDA	Current
55154-8131	Heparin Sodium	Heparin Sodium	Cardinal Health	ANDA	Current
55154-8138	Heparin Sodium	Heparin Sodium	Cardinal Health 107, LLC	ANDA	Current
55154-8138	Heparin Sodium	Heparin Sodium	Cardinal Health	ANDA	Current
63739-920	Heparin Sodium	Heparin Sodium	McKesson Packaging Services Business Unit of McKesson Corporation	ANDA	Current
63739-920	Heparin Sodium	Heparin Sodium	McKesson Packaging Services Business Unit of McKesson Corporation	ANDA	Current
63739-920	Heparin Sodium	Heparin Sodium	McKesson Packaging Services Business Unit of McKesson Corporation	ANDA	Current
63739-920	Heparin Sodium	Heparin Sodium	McKesson Packaging Services Business Unit of McKesson Corporation	ANDA	Current
63739-931	Heparin Sodium	Heparin Sodium	McKesson Packaging Services Business Unit of McKesson Corporation	ANDA	Current
63739-931	Heparin Sodium	Heparin Sodium	McKesson Packaging Services Business Unit of McKesson Corporation	ANDA	Current
63739-931	Heparin Sodium	Heparin Sodium	McKesson Packaging Services Business Unit of McKesson Corporation	ANDA	Current
63739-931	Heparin Sodium	Heparin Sodium	McKesson Packaging Services Business Unit of McKesson Corporation	ANDA	Current
63739-942	Heparin Sodium	Heparin Sodium	McKesson Packaging Services Business Unit of McKesson Corporation	ANDA	Current
63739-942	Heparin Sodium	Heparin Sodium	McKesson Packaging Services Business Unit of McKesson Corporation	ANDA	Current
63739-942	Heparin Sodium	Heparin Sodium	McKesson Packaging Services Business Unit of McKesson Corporation	ANDA	Current
63739-942	Heparin Sodium	Heparin Sodium	McKesson Packaging Services Business Unit of McKesson Corporation	ANDA	Current
63739-953	Heparin Sodium	Heparin Sodium	McKesson Packaging Services Business Unit of McKesson Corporation	ANDA	Current
63739-953	Heparin Sodium	Heparin Sodium	McKesson Packaging Services Business Unit of McKesson Corporation	ANDA	Current
63739-953	Heparin Sodium	Heparin Sodium	McKesson Packaging Services Business Unit of McKesson Corporation	ANDA	Current
63739-953	Heparin Sodium	Heparin Sodium	McKesson Packaging Services Business Unit of McKesson Corporation	ANDA	Current
81952-111	Heparin Sodium	Heparin Sodium	Hepalink USA, Inc.	ANDA	Current
81952-111	Heparin Sodium	Heparin Sodium	Hepalink USA, Inc.	ANDA	Current
81952-111	Heparin Sodium	Heparin Sodium	Hepalink USA, Inc.	ANDA	Current
81952-111	Heparin Sodium	Heparin Sodium	Hepalink USA, Inc.	ANDA	Current
81952-111	Heparin Sodium	Heparin Sodium	Hepalink USA Inc.	ANDA	Current
81952-111	Heparin Sodium	Heparin Sodium	Hepalink USA Inc.	ANDA	Current
81952-111	Heparin Sodium	Heparin Sodium	Hepalink USA Inc.	ANDA	Current
81952-111	Heparin Sodium	Heparin Sodium	Hepalink USA Inc.	ANDA	Current
81952-112	Heparin Sodium	Heparin Sodium	Hepalink USA Inc.	ANDA	Current
81952-112	Heparin Sodium	Heparin Sodium	Hepalink USA Inc.	ANDA	Current
81952-112	Heparin Sodium	Heparin Sodium	Hepalink USA Inc.	ANDA	Current
81952-112	Heparin Sodium	Heparin Sodium	Hepalink USA Inc.	ANDA	Current