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 3 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	Northstar Rx LLC	2edf6d35-5cf3-b7ff-e063-6394a90a4f33	2025-02-19	Warnings, Adverse reactions	Name fallback brand name: Heparin Sodium generic name: HEPARIN SODIUM
Heparin Sodium	HEPARIN SODIUM	Sandoz Inc.	1c634e53-44d6-cdcd-e063-6294a90a92e9	2025-02-19	Warnings, Adverse reactions	Name fallback brand name: Heparin Sodium generic name: HEPARIN SODIUM
Heparin Sodium	HEPARIN SODIUM	Meitheal Pharmaceuticals Inc.	7df6c90c-3b55-4bb6-8a72-6e6a6aca4e7c	2025-02-04	Warnings, Adverse reactions	Name fallback brand name: Heparin Sodium generic name: HEPARIN SODIUM
Heparin Sodium	HEPARIN SODIUM	Meitheal Pharmaceuticals Inc.	57f1ec87-8a7d-41da-b8b8-9ecc8601c60f	2025-01-22	Warnings, Adverse reactions	Name fallback brand name: Heparin Sodium generic name: HEPARIN SODIUM
Heparin Sodium	HEPARIN SODIUM	McKesson Corporation dba SKY Packaging	7f05762a-7527-4796-b21e-68277aec379e	2025-01-21	Warnings, Adverse reactions	Name fallback brand name: Heparin Sodium generic name: HEPARIN SODIUM
HEPARIN SODIUM	HEPARIN SODIUM	HF Acquisition Co LLC, DBA HealthFirst	9bd0f982-30f4-4e38-e053-2a95a90a3e15	2025-01-08	Warnings, Adverse reactions	Name fallback brand name: HEPARIN SODIUM generic name: HEPARIN SODIUM
HEPARIN SODIUM	HEPARIN SODIUM	HF Acquisition Co LLC, DBA HealthFirst	9a5549ae-527a-1b83-e053-2a95a90a133d	2025-01-08	Warnings, Adverse reactions	Name fallback brand name: HEPARIN SODIUM generic name: HEPARIN SODIUM
Heparin Sodium	HEPARIN SODIUM	Meitheal Pharmaceuticals Inc.	ad0f410c-6121-43f9-9844-943472961cb0	2025-01-08	Warnings, Adverse reactions	Name fallback brand name: Heparin Sodium generic name: HEPARIN SODIUM
Heparin Sodium	HEPARIN SODIUM	BE Pharmaceuticals Inc.	295ea9c6-d08c-40f0-a908-de0fdac44644	2024-10-30	Warnings, Adverse reactions	Name fallback brand name: Heparin Sodium generic name: HEPARIN SODIUM
Heparin Sodium	HEPARIN SODIUM	BE Pharmaceuticals Inc.	6be171fb-c85f-4336-a88d-b4d97bb0fe03	2024-10-30	Warnings, Adverse reactions	Name fallback brand name: Heparin Sodium generic name: HEPARIN SODIUM
Heparin Sodium	HEPARIN SODIUM	Phlow Corporation	cece935c-1c0a-4949-b023-d6df3d53fbfa	2024-05-16	Warnings, Adverse reactions	Name fallback brand name: Heparin Sodium generic name: HEPARIN SODIUM
Heparin Sodium	HEPARIN SODIUM	Fresenius Kabi USA, LLC	25b0ba06-3274-4a3f-8c39-42d13764ecdf	2024-04-30	Warnings, Adverse reactions	Name fallback brand name: Heparin Sodium generic name: HEPARIN SODIUM
Heparin Sodium	HEPARIN SODIUM	Fresenius Kabi USA, LLC	cb1c1e7a-c9ca-4a07-8833-e45ce436d287	2024-04-30	Warnings, Adverse reactions	Name fallback brand name: Heparin Sodium generic name: HEPARIN SODIUM
HEPARIN SODIUM	HEPARIN SODIUM	HF Acquisition Co LLC, DBA HealthFirst	971505d4-f78c-6f5d-e053-2995a90a00e0	2024-01-29	Warnings, Adverse reactions	Name fallback brand name: HEPARIN SODIUM generic name: HEPARIN SODIUM
Heparin Sodium	HEPARIN SODIUM	Fresenius Kabi USA, LLC	a120bdfd-21e1-4024-82a7-13cfeed290c1	2024-01-05	Warnings, Adverse reactions	Name fallback brand name: Heparin Sodium generic name: HEPARIN SODIUM
HEPARIN SODIUM IN SODIUM CHLORIDE	HEPARIN SODIUM	Baxter Healthcare Corporation	0d929726-76c3-48fc-b4e7-fd06409f9fb3	2022-01-03	Warnings, Adverse reactions	Name fallback generic name: HEPARIN SODIUM
Heparin Sodium	HEPARIN SODIUM	Fresenius Kabi USA, LLC	3facd525-b9ad-46d0-b63e-f13a5f6d591d	2021-09-01	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