Application 203198

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	10,000 UNITS/ML	No	No
002	HEPARIN SODIUM	HEPARIN SODIUM	INJECTABLE;INJECTION	20,000 UNITS/ML	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A203198-001	HEPARIN SODIUM	HEPARIN SODIUM	10,000 UNITS/ML	INJECTABLE / INJECTION	AP		2014-06-12
A203198-002	HEPARIN SODIUM	HEPARIN SODIUM	20,000 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
A203198-001	AP
A203198-002	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 · 84 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
2026-08-18 06:07:40	2026-07	A203198-001	HEPARIN SODIUM	10,000 UNITS/ML	INJECTABLE / INJECTION	AP	2014-06-12	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203198-002	HEPARIN SODIUM	20,000 UNITS/ML	INJECTABLE / INJECTION	AP	2014-06-12	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A203198-001	HEPARIN SODIUM	10,000 UNITS/ML	INJECTABLE / INJECTION	AP	2014-06-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203198-002	HEPARIN SODIUM	20,000 UNITS/ML	INJECTABLE / INJECTION	AP	2014-06-12	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203198-001	HEPARIN SODIUM	10,000 UNITS/ML	INJECTABLE / INJECTION	AP	2014-06-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203198-002	HEPARIN SODIUM	20,000 UNITS/ML	INJECTABLE / INJECTION	AP	2014-06-12	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203198-001	HEPARIN SODIUM	10,000 UNITS/ML	INJECTABLE / INJECTION	AP	2014-06-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203198-002	HEPARIN SODIUM	20,000 UNITS/ML	INJECTABLE / INJECTION	AP	2014-06-12	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203198-001	HEPARIN SODIUM	10,000 UNITS/ML	INJECTABLE / INJECTION	AP	2014-06-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203198-002	HEPARIN SODIUM	20,000 UNITS/ML	INJECTABLE / INJECTION	AP	2014-06-12	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203198-001	HEPARIN SODIUM	10,000 UNITS/ML	INJECTABLE / INJECTION	AP	2014-06-12	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203198-002	HEPARIN SODIUM	20,000 UNITS/ML	INJECTABLE / INJECTION	AP	2014-06-12	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203198-001	HEPARIN SODIUM	10,000 UNITS/ML	INJECTABLE / INJECTION	AP	2014-06-12	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203198-002	HEPARIN SODIUM	20,000 UNITS/ML	INJECTABLE / INJECTION	AP	2014-06-12	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203198-001	HEPARIN SODIUM	10,000 UNITS/ML	INJECTABLE / INJECTION	AP	2014-06-12	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203198-002	HEPARIN SODIUM	20,000 UNITS/ML	INJECTABLE / INJECTION	AP	2014-06-12	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203198-001	HEPARIN SODIUM	10,000 UNITS/ML	INJECTABLE / INJECTION	AP	2014-06-12	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203198-002	HEPARIN SODIUM	20,000 UNITS/ML	INJECTABLE / INJECTION	AP	2014-06-12	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203198-001	HEPARIN SODIUM	10,000 UNITS/ML	INJECTABLE / INJECTION	AP	2014-06-12	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203198-002	HEPARIN SODIUM	20,000 UNITS/ML	INJECTABLE / INJECTION	AP	2014-06-12	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203198-001	HEPARIN SODIUM	10,000 UNITS/ML	INJECTABLE / INJECTION	AP	2014-06-12	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203198-002	HEPARIN SODIUM	20,000 UNITS/ML	INJECTABLE / INJECTION	AP	2014-06-12	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203198-001	HEPARIN SODIUM	10,000 UNITS/ML	INJECTABLE / INJECTION	AP	2014-06-12	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203198-002	HEPARIN SODIUM	20,000 UNITS/ML	INJECTABLE / INJECTION	AP	2014-06-12	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203198-001	HEPARIN SODIUM	10,000 UNITS/ML	INJECTABLE / INJECTION	AP	2014-06-12	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203198-002	HEPARIN SODIUM	20,000 UNITS/ML	INJECTABLE / INJECTION	AP	2014-06-12	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203198-001	HEPARIN SODIUM	10,000 UNITS/ML	INJECTABLE / INJECTION	AP	2014-06-12	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203198-002	HEPARIN SODIUM	20,000 UNITS/ML	INJECTABLE / INJECTION	AP	2014-06-12	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203198-001	HEPARIN SODIUM	10,000 UNITS/ML	INJECTABLE / INJECTION	AP	2014-06-12	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A203198-002	HEPARIN SODIUM	20,000 UNITS/ML	INJECTABLE / INJECTION	AP	2014-06-12	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203198-001	HEPARIN SODIUM	10,000 UNITS/ML	INJECTABLE / INJECTION	AP	2014-06-12	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203198-002	HEPARIN SODIUM	20,000 UNITS/ML	INJECTABLE / INJECTION	AP	2014-06-12	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A203198-001	HEPARIN SODIUM	10,000 UNITS/ML	INJECTABLE / INJECTION	AP	2014-06-12	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A203198-002	HEPARIN SODIUM	20,000 UNITS/ML	INJECTABLE / INJECTION	AP	2014-06-12	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A203198-001	HEPARIN SODIUM	10,000 UNITS/ML	INJECTABLE / INJECTION	AP	2014-06-12	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A203198-002	HEPARIN SODIUM	20,000 UNITS/ML	INJECTABLE / INJECTION	AP	2014-06-12	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A203198-001	HEPARIN SODIUM	10,000 UNITS/ML	INJECTABLE / INJECTION	AP	2014-06-12	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A203198-002	HEPARIN SODIUM	20,000 UNITS/ML	INJECTABLE / INJECTION	AP	2014-06-12	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A203198-001	HEPARIN SODIUM	10,000 UNITS/ML	INJECTABLE / INJECTION	AP	2014-06-12	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A203198-002	HEPARIN SODIUM	20,000 UNITS/ML	INJECTABLE / INJECTION	AP	2014-06-12	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A203198-001	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203198-002	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A203198-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203198-002	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203198-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203198-002	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203198-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203198-002	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203198-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203198-002	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203198-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203198-002	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203198-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203198-002	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203198-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203198-002	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203198-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203198-002	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203198-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203198-002	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203198-001	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203198-002	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203198-001	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203198-002	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203198-001	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203198-002	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203198-001	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203198-002	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203198-001	AP	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A203198-002	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203198-001	AP	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203198-002	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A203198-001	AP	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A203198-002	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A203198-001	AP	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A203198-002	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A203198-001	AP	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A203198-002	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A203198-001	AP	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A203198-002	AP	1	`bb7c543d1eb4…`

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	Hepalink USA Inc.	c4c6bc1f-e0c7-fd0d-e053-2995a90abdef	2025-02-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203198 application number: ANDA203198 ndc (product): 81952-113 ndc (product): 81952-116
Heparin Sodium	HEPARIN SODIUM	Northstar Rx LLC	2edf6d35-5cf3-b7ff-e063-6394a90a4f33	2025-02-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203198 application number: ANDA203198
Heparin Sodium	HEPARIN SODIUM	Sandoz Inc.	1c634e53-44d6-cdcd-e063-6294a90a92e9	2025-02-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203198 application number: ANDA203198
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): 203198 application number: ANDA203198 ndc (product): 63739-986 ndc (product): 63739-964 ndc (product): 63739-975
HEPARIN SODIUM	HEPARIN SODIUM	HF Acquisition Co LLC, DBA HealthFirst	9bd0f982-30f4-4e38-e053-2a95a90a3e15	2025-01-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203198 application number: ANDA203198 ndc (product): 51662-1434

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 21 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
48433-330	Heparin Sodium	Heparin Sodium	Safecor Health, LLC	ANDA	Current
51662-1434	HEPARIN SODIUM	HEPARIN SODIUM	HF Acquisition Co LLC, DBA HealthFirst	ANDA	Current
51662-1434	HEPARIN SODIUM	HEPARIN SODIUM	HF Acquisition Co LLC, DBA HealthFirst	ANDA	Current
63739-964	Heparin Sodium	Heparin Sodium	McKesson Packaging Services Business Unit of McKesson Corporation	ANDA	Current
63739-964	Heparin Sodium	Heparin Sodium	McKesson Packaging Services Business Unit of McKesson Corporation	ANDA	Current
63739-964	Heparin Sodium	Heparin Sodium	McKesson Packaging Services Business Unit of McKesson Corporation	ANDA	Current
63739-964	Heparin Sodium	Heparin Sodium	McKesson Packaging Services Business Unit of McKesson Corporation	ANDA	Current
63739-975	Heparin Sodium	Heparin Sodium	McKesson Packaging Services Business Unit of McKesson Corporation	ANDA	Current
63739-975	Heparin Sodium	Heparin Sodium	McKesson Packaging Services Business Unit of McKesson Corporation	ANDA	Current
63739-975	Heparin Sodium	Heparin Sodium	McKesson Packaging Services Business Unit of McKesson Corporation	ANDA	Current
63739-975	Heparin Sodium	Heparin Sodium	McKesson Packaging Services Business Unit of McKesson Corporation	ANDA	Current
63739-986	Heparin Sodium	Heparin Sodium	McKesson Packaging Services Business Unit of McKesson Corporation	ANDA	Current
63739-986	Heparin Sodium	Heparin Sodium	McKesson Packaging Services Business Unit of McKesson Corporation	ANDA	Current
63739-986	Heparin Sodium	Heparin Sodium	McKesson Packaging Services Business Unit of McKesson Corporation	ANDA	Current
63739-986	Heparin Sodium	Heparin Sodium	McKesson Packaging Services Business Unit of McKesson Corporation	ANDA	Current
81952-113	Heparin Sodium	Heparin Sodium	Hepalink USA Inc.	ANDA	Current
81952-113	Heparin Sodium	Heparin Sodium	Hepalink USA Inc.	ANDA	Current
81952-113	Heparin Sodium	Heparin Sodium	Hepalink USA Inc.	ANDA	Current
81952-116	Heparin Sodium	Heparin Sodium	Hepalink USA Inc.	ANDA	Current
81952-116	Heparin Sodium	Heparin Sodium	Hepalink USA Inc.	ANDA	Current
81952-116	Heparin Sodium	Heparin Sodium	Hepalink USA Inc.	ANDA	Current