Application 091659

Type: ANDA
Sponsor: CASI PHARMS INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A091659-001	HEPARIN SODIUM	HEPARIN SODIUM	5,000 UNITS/ML	INJECTABLE / INJECTION			2011-06-08

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 · 41 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	A091659-001	HEPARIN SODIUM	5,000 UNITS/ML	INJECTABLE / INJECTION		2011-06-08	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091659-001	HEPARIN SODIUM	5,000 UNITS/ML	INJECTABLE / INJECTION		2011-06-08	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091659-001	HEPARIN SODIUM	5,000 UNITS/ML	INJECTABLE / INJECTION		2011-06-08	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091659-001	HEPARIN SODIUM	5,000 UNITS/ML	INJECTABLE / INJECTION		2011-06-08	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091659-001	HEPARIN SODIUM	5,000 UNITS/ML	INJECTABLE / INJECTION		2011-06-08	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091659-001	HEPARIN SODIUM	5,000 UNITS/ML	INJECTABLE / INJECTION		2011-06-08	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091659-001	HEPARIN SODIUM	5,000 UNITS/ML	INJECTABLE / INJECTION		2011-06-08	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091659-001	HEPARIN SODIUM	5,000 UNITS/ML	INJECTABLE / INJECTION		2011-06-08	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091659-001	HEPARIN SODIUM	5,000 UNITS/ML	INJECTABLE / INJECTION		2011-06-08	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091659-001	HEPARIN SODIUM	5,000 UNITS/ML	INJECTABLE / INJECTION		2011-06-08	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091659-001	HEPARIN SODIUM	5,000 UNITS/ML	INJECTABLE / INJECTION		2011-06-08	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091659-001	HEPARIN SODIUM	5,000 UNITS/ML	INJECTABLE / INJECTION		2011-06-08	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091659-001	HEPARIN SODIUM	5,000 UNITS/ML	INJECTABLE / INJECTION		2011-06-08	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091659-001	HEPARIN SODIUM	5,000 UNITS/ML	INJECTABLE / INJECTION		2011-06-08	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091659-001	HEPARIN SODIUM	5,000 UNITS/ML	INJECTABLE / INJECTION		2011-06-08	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091659-001	HEPARIN SODIUM	5,000 UNITS/ML	INJECTABLE / INJECTION		2011-06-08	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091659-001	HEPARIN SODIUM	5,000 UNITS/ML	INJECTABLE / INJECTION		2011-06-08	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A091659-001	HEPARIN SODIUM	5,000 UNITS/ML	INJECTABLE / INJECTION	AP	2011-06-08	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A091659-001	HEPARIN SODIUM	5,000 UNITS/ML	INJECTABLE / INJECTION		2011-06-08	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A091659-001	HEPARIN SODIUM	5,000 UNITS/ML	INJECTABLE / INJECTION		2011-06-08	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A091659-001	HEPARIN SODIUM	5,000 UNITS/ML	INJECTABLE / INJECTION		2011-06-08	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A091659-001	HEPARIN SODIUM	5,000 UNITS/ML	INJECTABLE / INJECTION		2011-06-08	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A091659-001	HEPARIN SODIUM	5,000 UNITS/ML	INJECTABLE / INJECTION		2011-06-08	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A091659-001	HEPARIN SODIUM	5,000 UNITS/ML	INJECTABLE / INJECTION	AP	2011-06-08	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A091659-001	HEPARIN SODIUM	5,000 UNITS/ML	INJECTABLE / INJECTION	AP	2011-06-08	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A091659-001	HEPARIN SODIUM	5,000 UNITS/ML	INJECTABLE / INJECTION	AP	2011-06-08	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A091659-001	HEPARIN SODIUM	5,000 UNITS/ML	INJECTABLE / INJECTION	AP	2011-06-08	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A091659-001	HEPARIN SODIUM	5,000 UNITS/ML	INJECTABLE / INJECTION		2011-06-08	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A091659-001	HEPARIN SODIUM	5,000 UNITS/ML	INJECTABLE / INJECTION		2011-06-08	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A091659-001	HEPARIN SODIUM	5,000 UNITS/ML	INJECTABLE / INJECTION		2011-06-08	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A091659-001	HEPARIN SODIUM	5,000 UNITS/ML	INJECTABLE / INJECTION		2011-06-08	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A091659-001	HEPARIN SODIUM	5,000 UNITS/ML	INJECTABLE / INJECTION		2011-06-08	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A091659-001	HEPARIN SODIUM	5,000 UNITS/ML	INJECTABLE / INJECTION		2011-06-08	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A091659-001	HEPARIN SODIUM	5,000 UNITS/ML	INJECTABLE / INJECTION		2011-06-08	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A091659-001	HEPARIN SODIUM	5,000 UNITS/ML	INJECTABLE / INJECTION		2011-06-08	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A091659-001	HEPARIN SODIUM	5,000 UNITS/ML	INJECTABLE / INJECTION		2011-06-08	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A091659-001	HEPARIN SODIUM	5,000 UNITS/ML	INJECTABLE / INJECTION		2011-06-08	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A091659-001	HEPARIN SODIUM	5,000 UNITS/ML	INJECTABLE / INJECTION		2011-06-08	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A091659-001	HEPARIN SODIUM	5,000 UNITS/ML	INJECTABLE / INJECTION		2011-06-08	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A091659-001	HEPARIN SODIUM	5,000 UNITS/ML	INJECTABLE / INJECTION		2011-06-08	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A091659-001	AP	1	`74a2ff9319b5…`
2020-11-12 02:37 UTC	2020-11	A091659-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A091659-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A091659-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A091659-001	AP	1	`ea99ee380514…`

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 3 · 59 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Heparin Sodium	HEPARIN SODIUM	Cardinal Health 107, LLC	9ea0a519-dc7c-42e3-939e-2a7c80eedd25	2026-07-10	Warnings, Adverse reactions	Name fallback brand name: Heparin Sodium generic name: HEPARIN SODIUM
Heparin Sodium	HEPARIN SODIUM	Cardinal Health 107, LLC	e0cc5f44-9a67-4274-a48a-d6118e96d391	2026-06-25	Warnings, Adverse reactions	Name fallback brand name: Heparin Sodium generic name: HEPARIN SODIUM
Heparin Sodium	HEPARIN SODIUM	Cardinal Health 107, LLC	62cfd1bb-894f-4429-b362-1e40981dccc6	2026-06-11	Warnings, Adverse reactions	Name fallback brand name: Heparin Sodium generic name: HEPARIN SODIUM
Heparin Sodium	HEPARIN SODIUM	Cardinal Health 107, LLC	9cd7abe6-3923-4007-8491-273ef6e05ad7	2026-06-02	Warnings, Adverse reactions	Name fallback brand name: Heparin Sodium generic name: HEPARIN SODIUM
Heparin Sodium and Dextrose	HEPARIN SODIUM	Hospira, Inc.	eede8a0c-5ae6-4166-84b3-12081405f08e	2026-05-25	Warnings, Adverse reactions	Name fallback generic name: HEPARIN SODIUM
Heparin Sodium	HEPARIN SODIUM	Cardinal Health 107, LLC	f67eea4e-80ff-48da-8b04-8addc5cd31d1	2026-05-12	Warnings, Adverse reactions	Name fallback brand name: Heparin Sodium generic name: HEPARIN SODIUM
Heparin Sodium	HEPARIN SODIUM	Hospira, Inc.	0413f511-6b34-4c15-e48b-3fad08baacbe	2026-05-12	Warnings, Adverse reactions	Name fallback brand name: Heparin Sodium generic name: HEPARIN SODIUM
Heparin Sodium	HEPARIN SODIUM	Hospira, Inc.	32e34077-aff1-4ec7-f9b0-b8e240768fb8	2026-05-12	Warnings, Adverse reactions	Name fallback brand name: Heparin Sodium generic name: HEPARIN SODIUM
HEPARIN SODIUM	HEPARIN SODIUM	HF Acquisition Co LLC, DBA HealthFirst	51197aa6-de34-3a55-e063-6294a90a89c9	2026-05-05	Warnings, Adverse reactions	Name fallback brand name: HEPARIN SODIUM generic name: HEPARIN SODIUM
Heparin Sodium	HEPARIN SODIUM	Fresenius Kabi USA, LLC	2a173253-dfdc-4d9d-8dee-b9c13e6fa9f5	2026-04-30	Warnings, Adverse reactions	Name fallback brand name: Heparin Sodium generic name: HEPARIN SODIUM
Heparin Sodium	HEPARIN SODIUM	Hospira, Inc.	c8c4edd2-ee9e-4558-6b8c-b83adc242a0a	2026-04-29	Warnings, Adverse reactions	Name fallback brand name: Heparin Sodium generic name: HEPARIN SODIUM
Heparin Sodium	HEPARIN SODIUM	Plano Pharmaceuticals Inc.	4deaa9ac-91aa-d96b-e063-6294a90a47bd	2026-03-25	Warnings, Adverse reactions	Name fallback brand name: Heparin Sodium generic name: HEPARIN SODIUM
Heparin Sodium	HEPARIN SODIUM	Hospira, Inc.	6c181d7e-aed2-4975-30ac-d39a94cca7ec	2026-03-24	Warnings, Adverse reactions	Name fallback brand name: Heparin Sodium generic name: HEPARIN SODIUM
Heparin Sodium	HEPARIN SODIUM	Medical Purchasing Solutions, LLC	4c118b39-cb4e-31a9-e063-6394a90a41b0	2026-03-02	Warnings, Adverse reactions	Name fallback brand name: Heparin Sodium generic name: HEPARIN SODIUM
Heparin Sodium	HEPARIN SODIUM	REMEDYREPACK INC.	a5fab0b1-c472-489c-ba87-2f8e53356173	2026-01-16	Warnings, Adverse reactions	Name fallback brand name: Heparin Sodium generic name: HEPARIN SODIUM
Heparin Sodium	HEPARIN SODIUM	Medical Purchasing Solutions, LLC	463e0624-b8c3-386b-e063-6294a90afd28	2025-12-18	Warnings, Adverse reactions	Name fallback brand name: Heparin Sodium generic name: HEPARIN SODIUM
Heparin Sodium	HEPARIN SODIUM	Fresenius Kabi USA, LLC	d55b4a63-0c04-4874-b74f-9e9b9e8b008c	2025-11-28	Warnings, Adverse reactions	Name fallback brand name: Heparin Sodium generic name: HEPARIN SODIUM
Heparin Sodium	HEPARIN SODIUM	Fresenius Kabi USA, LLC	ed937dd2-8fab-4875-a1e8-627b71ccb7fb	2025-11-27	Warnings, Adverse reactions	Name fallback brand name: Heparin Sodium generic name: HEPARIN SODIUM
Heparin Sodium	HEPARIN SODIUM	Sagent Pharmaceticals	ef309d83-7262-4874-8580-f4ca254f963a	2025-11-18	Warnings, Adverse reactions	Name fallback brand name: Heparin Sodium generic name: HEPARIN SODIUM
Heparin Sodium	HEPARIN SODIUM	Sagent Pharmaceuticals	6d5eae7d-a5f6-411c-b589-3e5f7eecc875	2025-11-18	Warnings, Adverse reactions	Name fallback brand name: Heparin Sodium generic name: HEPARIN SODIUM