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 2 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	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
Heparin Sodium	HEPARIN SODIUM	Sagent Pharmaceuticals	feec2820-502f-4a97-84c9-f173729c51d3	2025-11-18	Warnings, Adverse reactions	Name fallback brand name: Heparin Sodium generic name: HEPARIN SODIUM
Heparin Sodium	HEPARIN SODIUM	Sagent Pharmaceuticals	8ebe4b4d-cb28-47e8-9598-6105d250b3d2	2025-11-18	Warnings, Adverse reactions	Name fallback brand name: Heparin Sodium generic name: HEPARIN SODIUM
Heparin Sodium	HEPARIN SODIUM	Henry Schein, Inc.	3a998729-c912-4e21-8e49-d1e72ba6fe9e	2025-10-31	Warnings, Adverse reactions	Name fallback brand name: Heparin Sodium generic name: HEPARIN SODIUM
Heparin Sodium	HEPARIN SODIUM	Pfizer Laboratories Div Pfizer Inc	56dc3074-f1c5-45a3-b923-f1d14858e06d	2025-10-03	Warnings, Adverse reactions	Name fallback brand name: Heparin Sodium generic name: HEPARIN SODIUM
Heparin Sodium	HEPARIN SODIUM	Meitheal Pharmaceuticals Inc.	02fb700d-a28c-4d45-b78d-382dc0d5986c	2025-09-26	Warnings, Adverse reactions	Name fallback brand name: Heparin Sodium generic name: HEPARIN SODIUM
Heparin Sodium	HEPARIN SODIUM	Medical Purchasing Solutions, LLC	3edf9198-b88d-7808-e063-6394a90ae89c	2025-09-15	Warnings, Adverse reactions	Name fallback brand name: Heparin Sodium generic name: HEPARIN SODIUM
Heparin Sodium	HEPARIN SODIUM	Medical Purchasing Solutions, LLC.	3ea2bd53-ed13-a516-e063-6394a90a5dd9	2025-09-12	Warnings, Adverse reactions	Name fallback brand name: Heparin Sodium generic name: HEPARIN SODIUM
Heparin Sodium	HEPARIN SODIUM	Fresenius Kabi USA, LLC	9207cef5-4cec-41e7-a351-29ba726feb44	2025-08-15	Warnings, Adverse reactions	Name fallback brand name: Heparin Sodium generic name: HEPARIN SODIUM
Heparin Sodium	HEPARIN SODIUM	Fresenius Kabi USA, LLC	07438e10-1589-4683-9f26-e5494d076cf0	2025-08-15	Warnings, Adverse reactions	Name fallback brand name: Heparin Sodium generic name: HEPARIN SODIUM
Heparin Sodium	HEPARIN SODIUM	Hikma Pharmaceuticals USA Inc.	7014808d-cec9-4b2c-8eb5-940493e356ab	2025-08-13	Warnings, Adverse reactions	Name fallback brand name: Heparin Sodium generic name: HEPARIN SODIUM
Heparin Sodium	HEPARIN SODIUM	Civica, Inc.	1e362730-5a56-4948-a90f-2cb75fed9e91	2025-07-12	Warnings, Adverse reactions	Name fallback brand name: Heparin Sodium generic name: HEPARIN SODIUM
Heparin Sodium	HEPARIN SODIUM	NorthStar RxLLC	34b8fe93-ee34-4a35-9af5-5d41705a28e9	2025-05-29	Warnings, Adverse reactions	Name fallback brand name: Heparin Sodium generic name: HEPARIN SODIUM
Heparin Sodium	HEPARIN SODIUM	NorthStar RxLLC	c4fa6d34-e76b-4c3c-b74d-21ce41432a04	2025-05-29	Warnings, Adverse reactions	Name fallback brand name: Heparin Sodium generic name: HEPARIN SODIUM
Heparin Sodium	HEPARIN SODIUM	NorthStar RxLLC	41dd053d-49f6-4eb1-b9e7-3508ede82df8	2025-05-29	Warnings, Adverse reactions	Name fallback brand name: Heparin Sodium generic name: HEPARIN SODIUM
HEPARIN SODIUM	HEPARIN SODIUM	HF Acquisition Co LLC, DBA HealthFirst	a07195bc-7442-32b4-e053-2995a90a0151	2025-05-07	Warnings, Adverse reactions	Name fallback brand name: HEPARIN SODIUM generic name: HEPARIN SODIUM
Heparin Sodium	HEPARIN SODIUM	Mylan Institutional LLC	88114716-5759-4bc9-8a85-d28da12962cc	2025-04-15	Warnings, Adverse reactions	Name fallback brand name: Heparin Sodium generic name: HEPARIN SODIUM
Heparin Sodium	HEPARIN SODIUM	Meitheal Pharmaceuticals Inc.	83a59e7d-63e9-4eb8-87f0-52039d6893a5	2025-03-18	Warnings, Adverse reactions	Name fallback brand name: Heparin Sodium generic name: HEPARIN SODIUM
Heparin Sodium	HEPARIN SODIUM	Hepalink USA Inc.	c4c6bc1f-e0c7-fd0d-e053-2995a90abdef	2025-02-19	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