Application 205323

Type: ANDA
Sponsor: GLAND PHARMA LTD

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
002	HEPARIN SODIUM	HEPARIN SODIUM	INJECTABLE;INJECTION	1,000 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 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A205323-001	HEPARIN SODIUM	HEPARIN SODIUM	5,000 UNITS/ML	INJECTABLE / INJECTION	AP		2017-02-06
A205323-002	HEPARIN SODIUM	HEPARIN SODIUM	1,000 UNITS/ML	INJECTABLE / INJECTION	AP		2019-11-18

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A205323-001	AP
A205323-002	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
2026-09-14 22:38:34	2026-08	A205323-001	HEPARIN SODIUM	5,000 UNITS/ML	INJECTABLE / INJECTION	AP	2017-02-06	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A205323-002	HEPARIN SODIUM	1,000 UNITS/ML	INJECTABLE / INJECTION	AP	2019-11-18	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A205323-001	HEPARIN SODIUM	5,000 UNITS/ML	INJECTABLE / INJECTION	AP	2017-02-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A205323-002	HEPARIN SODIUM	1,000 UNITS/ML	INJECTABLE / INJECTION	AP	2019-11-18	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A205323-001	HEPARIN SODIUM	5,000 UNITS/ML	INJECTABLE / INJECTION	AP	2017-02-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205323-002	HEPARIN SODIUM	1,000 UNITS/ML	INJECTABLE / INJECTION	AP	2019-11-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205323-001	HEPARIN SODIUM	5,000 UNITS/ML	INJECTABLE / INJECTION	AP	2017-02-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205323-002	HEPARIN SODIUM	1,000 UNITS/ML	INJECTABLE / INJECTION	AP	2019-11-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205323-001	HEPARIN SODIUM	5,000 UNITS/ML	INJECTABLE / INJECTION	AP	2017-02-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205323-002	HEPARIN SODIUM	1,000 UNITS/ML	INJECTABLE / INJECTION	AP	2019-11-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205323-001	HEPARIN SODIUM	5,000 UNITS/ML	INJECTABLE / INJECTION	AP	2017-02-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205323-002	HEPARIN SODIUM	1,000 UNITS/ML	INJECTABLE / INJECTION	AP	2019-11-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205323-001	HEPARIN SODIUM	5,000 UNITS/ML	INJECTABLE / INJECTION	AP	2017-02-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205323-002	HEPARIN SODIUM	1,000 UNITS/ML	INJECTABLE / INJECTION	AP	2019-11-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205323-001	HEPARIN SODIUM	5,000 UNITS/ML	INJECTABLE / INJECTION	AP	2017-02-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205323-002	HEPARIN SODIUM	1,000 UNITS/ML	INJECTABLE / INJECTION	AP	2019-11-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205323-001	HEPARIN SODIUM	5,000 UNITS/ML	INJECTABLE / INJECTION	AP	2017-02-06	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205323-002	HEPARIN SODIUM	1,000 UNITS/ML	INJECTABLE / INJECTION	AP	2019-11-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205323-001	HEPARIN SODIUM	5,000 UNITS/ML	INJECTABLE / INJECTION	AP	2017-02-06	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205323-002	HEPARIN SODIUM	1,000 UNITS/ML	INJECTABLE / INJECTION	AP	2019-11-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205323-001	HEPARIN SODIUM	5,000 UNITS/ML	INJECTABLE / INJECTION	AP	2017-02-06	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205323-002	HEPARIN SODIUM	1,000 UNITS/ML	INJECTABLE / INJECTION	AP	2019-11-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A205323-001	HEPARIN SODIUM	5,000 UNITS/ML	INJECTABLE / INJECTION	AP	2017-02-06	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A205323-002	HEPARIN SODIUM	1,000 UNITS/ML	INJECTABLE / INJECTION	AP	2019-11-18	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205323-001	HEPARIN SODIUM	5,000 UNITS/ML	INJECTABLE / INJECTION	AP	2017-02-06	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205323-002	HEPARIN SODIUM	1,000 UNITS/ML	INJECTABLE / INJECTION	AP	2019-11-18	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205323-001	HEPARIN SODIUM	5,000 UNITS/ML	INJECTABLE / INJECTION	AP	2017-02-06	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205323-002	HEPARIN SODIUM	1,000 UNITS/ML	INJECTABLE / INJECTION	AP	2019-11-18	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205323-001	HEPARIN SODIUM	5,000 UNITS/ML	INJECTABLE / INJECTION	AP	2017-02-06	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205323-002	HEPARIN SODIUM	1,000 UNITS/ML	INJECTABLE / INJECTION	AP	2019-11-18	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A205323-001	HEPARIN SODIUM	5,000 UNITS/ML	INJECTABLE / INJECTION	AP	2017-02-06	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A205323-002	HEPARIN SODIUM	1,000 UNITS/ML	INJECTABLE / INJECTION	AP	2019-11-18	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A205323-001	HEPARIN SODIUM	5,000 UNITS/ML	INJECTABLE / INJECTION	AP	2017-02-06	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A205323-002	HEPARIN SODIUM	1,000 UNITS/ML	INJECTABLE / INJECTION	AP	2019-11-18	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A205323-001	HEPARIN SODIUM	5,000 UNITS/ML	INJECTABLE / INJECTION	AP	2017-02-06	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A205323-002	HEPARIN SODIUM	1,000 UNITS/ML	INJECTABLE / INJECTION	AP	2019-11-18	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A205323-001	HEPARIN SODIUM	5,000 UNITS/ML	INJECTABLE / INJECTION	AP	2017-02-06	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A205323-002	HEPARIN SODIUM	1,000 UNITS/ML	INJECTABLE / INJECTION	AP	2019-11-18	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A205323-001	HEPARIN SODIUM	5,000 UNITS/ML	INJECTABLE / INJECTION	AP	2017-02-06	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A205323-001	HEPARIN SODIUM	5,000 UNITS/ML	INJECTABLE / INJECTION	AP	2017-02-06	`bb7c543d1eb4…`

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
2026-09-14 22:38:34	2026-08	A205323-001	AP	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A205323-002	AP	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A205323-001	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A205323-002	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A205323-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205323-002	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205323-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205323-002	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205323-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205323-002	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205323-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205323-002	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205323-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205323-002	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205323-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205323-002	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205323-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205323-002	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205323-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205323-002	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205323-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205323-002	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A205323-001	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A205323-002	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205323-001	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205323-002	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205323-001	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205323-002	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205323-001	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205323-002	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A205323-001	AP	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A205323-002	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A205323-001	AP	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A205323-002	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A205323-001	AP	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A205323-002	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A205323-001	AP	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A205323-002	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A205323-001	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A205323-001	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 3 · 57 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Heparin Sodium	HEPARIN SODIUM	Hospira, Inc.	c8c4edd2-ee9e-4558-6b8c-b83adc242a0a	2026-08-25	Warnings, Adverse reactions	Name fallback brand name: Heparin Sodium generic name: HEPARIN SODIUM
Heparin Sodium	HEPARIN SODIUM	Henry Schein, Inc.	45dc6b8b-ed5d-40a2-8d9c-084c863ae93a	2026-08-19	Warnings, Adverse reactions	Name fallback brand name: Heparin Sodium generic name: HEPARIN SODIUM
Heparin Sodium	HEPARIN SODIUM	Cardinal Health 107, LLC	239b4816-6a55-451b-bf40-e611be07d12f	2026-08-10	Warnings, Adverse reactions	Name fallback brand name: Heparin Sodium generic name: HEPARIN SODIUM
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	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

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

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

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
68083-136	Heparin Sodium	Heparin Sodium	Gland Pharma Limited	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
47136	ORIG	2017-02-08