Application 078660

Type: ANDA
Sponsor: SANDOZ INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ENOXAPARIN SODIUM	ENOXAPARIN SODIUM	INJECTABLE;INTRAVENOUS, SUBCUTANEOUS	300MG/3ML (100MG/ML)	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
A078660-001	ENOXAPARIN SODIUM	ENOXAPARIN SODIUM	300MG/3ML (100MG/ML)	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS	AB		2011-11-28

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A078660-001	AB

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 · 44 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
2026-10-15 13:18:30	2026-09	A078660-001	ENOXAPARIN SODIUM	300MG/3ML (100MG/ML)	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS	AB	2011-11-28	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A078660-001	ENOXAPARIN SODIUM	300MG/3ML (100MG/ML)	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS	AB	2011-11-28	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A078660-001	ENOXAPARIN SODIUM	300MG/3ML (100MG/ML)	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS	AB	2011-11-28	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078660-001	ENOXAPARIN SODIUM	300MG/3ML (100MG/ML)	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS	AB	2011-11-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078660-001	ENOXAPARIN SODIUM	300MG/3ML (100MG/ML)	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS	AB	2011-11-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078660-001	ENOXAPARIN SODIUM	300MG/3ML (100MG/ML)	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS	AB	2011-11-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078660-001	ENOXAPARIN SODIUM	300MG/3ML (100MG/ML)	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS	AB	2011-11-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078660-001	ENOXAPARIN SODIUM	300MG/3ML (100MG/ML)	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS	AB	2011-11-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078660-001	ENOXAPARIN SODIUM	300MG/3ML (100MG/ML)	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS	AB	2011-11-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078660-001	ENOXAPARIN SODIUM	300MG/3ML (100MG/ML)	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS	AB	2011-11-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078660-001	ENOXAPARIN SODIUM	300MG/3ML (100MG/ML)	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS	AB	2011-11-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078660-001	ENOXAPARIN SODIUM	300MG/3ML (100MG/ML)	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS	AB	2011-11-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078660-001	ENOXAPARIN SODIUM	300MG/3ML (100MG/ML)	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS	AB	2011-11-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078660-001	ENOXAPARIN SODIUM	300MG/3ML (100MG/ML)	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS	AB	2011-11-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078660-001	ENOXAPARIN SODIUM	300MG/3ML (100MG/ML)	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS	AB	2011-11-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078660-001	ENOXAPARIN SODIUM	300MG/3ML (100MG/ML)	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS	AB	2011-11-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078660-001	ENOXAPARIN SODIUM	300MG/3ML (100MG/ML)	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS	AB	2011-11-28	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078660-001	ENOXAPARIN SODIUM	300MG/3ML (100MG/ML)	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS	AB	2011-11-28	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078660-001	ENOXAPARIN SODIUM	300MG/3ML (100MG/ML)	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS	AB	2011-11-28	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078660-001	ENOXAPARIN SODIUM	300MG/3ML (100MG/ML)	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS	AB	2011-11-28	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078660-001	ENOXAPARIN SODIUM	300MG/3ML (100MG/ML)	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS	AB	2011-11-28	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078660-001	ENOXAPARIN SODIUM	300MG/3ML (100MG/ML)	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS	AB	2011-11-28	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078660-001	ENOXAPARIN SODIUM	300MG/3ML (100MG/ML)	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS	AB	2011-11-28	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078660-001	ENOXAPARIN SODIUM	300MG/3ML (100MG/ML)	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS	AB	2011-11-28	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A078660-001	ENOXAPARIN SODIUM	300MG/3ML (100MG/ML)	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS	AB	2011-11-28	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A078660-001	ENOXAPARIN SODIUM	300MG/3ML (100MG/ML)	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS	AB	2011-11-28	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A078660-001	ENOXAPARIN SODIUM	300MG/3ML (100MG/ML)	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS	AB	2011-11-28	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A078660-001	ENOXAPARIN SODIUM	300MG/3ML (100MG/ML)	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS	AB	2011-11-28	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A078660-001	ENOXAPARIN SODIUM	300MG/3ML (100MG/ML)	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS	AB	2011-11-28	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A078660-001	ENOXAPARIN SODIUM	300MG/3ML (100MG/ML)	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS	AB	2011-11-28	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A078660-001	ENOXAPARIN SODIUM	300MG/3ML (100MG/ML)	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS	AB	2011-11-28	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A078660-001	ENOXAPARIN SODIUM	300MG/3ML (100MG/ML)	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS	AB	2011-11-28	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A078660-001	ENOXAPARIN SODIUM	300MG/3ML (100MG/ML)	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS	AB	2011-11-28	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A078660-001	ENOXAPARIN SODIUM	300MG/3ML (100MG/ML)	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS	AB	2011-11-28	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A078660-001	ENOXAPARIN SODIUM	300MG/3ML (100MG/ML)	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS	AB	2011-11-28	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A078660-001	ENOXAPARIN SODIUM	300MG/3ML (100MG/ML)	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS	AB	2011-11-28	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A078660-001	ENOXAPARIN SODIUM	300MG/3ML (100MG/ML)	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS	AB	2011-11-28	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A078660-001	ENOXAPARIN SODIUM	300MG/3ML (100MG/ML)	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS	AB	2011-11-28	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A078660-001	ENOXAPARIN SODIUM	300MG/3ML (100MG/ML)	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS	AB	2011-11-28	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A078660-001	ENOXAPARIN SODIUM	300MG/3ML (100MG/ML)	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS	AB	2011-11-28	`3a93d1ddd44b…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 44 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-10-15 13:18:30	2026-09	A078660-001	AB	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A078660-001	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A078660-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078660-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078660-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078660-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078660-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078660-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078660-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078660-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078660-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078660-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078660-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078660-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078660-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078660-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078660-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078660-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078660-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078660-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078660-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078660-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078660-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078660-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A078660-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A078660-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A078660-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A078660-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A078660-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A078660-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A078660-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A078660-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A078660-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A078660-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A078660-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A078660-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A078660-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A078660-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A078660-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A078660-001	AB	1	`3a93d1ddd44b…`

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 2 · 24 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Enoxaparin Sodium	ENOXAPARIN SODIUM	Cardinal Health 107, LLC	45a66675-b159-42b8-9f18-ff80f28e1503	2026-09-02	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Enoxaparin Sodium generic name: ENOXAPARIN SODIUM
Lovenox	ENOXAPARIN SODIUM	Sanofi-Aventis U.S. LLC	5017a927-2a24-4f27-89f9-27c805bf7d59	2026-05-28	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ENOXAPARIN SODIUM
Enoxaparin Sodium	ENOXAPARIN SODIUM	Cardinal Health 107, LLC	5e7568a6-cf8a-4de2-86ba-b94c8ab4c806	2026-05-05	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Enoxaparin Sodium generic name: ENOXAPARIN SODIUM
Lovenox	ENOXAPARIN SODIUM	Cardinal Health 107, LLC	3d263380-4f44-4fd8-aa2a-e69702ab258f	2026-04-27	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ENOXAPARIN SODIUM
Enoxaparin Sodium	ENOXAPARIN SODIUM	Fresenius Kabi USA, LLC	c3be543e-8aff-4311-bf77-e7a5a814ca6f	2026-04-09	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Enoxaparin Sodium generic name: ENOXAPARIN SODIUM
enoxaparin sodium	ENOXAPARIN SODIUM	BE Pharmaceuticals Inc.	b7197534-1daa-42de-8b83-a727da1195bf	2026-03-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: enoxaparin sodium generic name: ENOXAPARIN SODIUM
Lovenox	ENOXAPARIN SODIUM	Sanofi-Aventis U.S. LLC	de6fb917-a94a-41ea-9d7d-937d4080ffcd	2026-02-06	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ENOXAPARIN SODIUM
Enoxaparin Sodium	ENOXAPARIN SODIUM	Fresenius Kabi USA, LLC	21b095d1-5ade-43e9-9114-30fbfb2331c9	2026-02-04	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Enoxaparin Sodium generic name: ENOXAPARIN SODIUM
Enoxaparin Sodium	ENOXAPARIN SODIUM	Fresenius Kabi USA, LLC	066f27ec-352c-4051-ba29-248e292690db	2026-02-04	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Enoxaparin Sodium generic name: ENOXAPARIN SODIUM
ENOXAPARIN SODIUM	ENOXAPARIN SODIUM	Gland Pharma Limited	65025e0d-eb54-4c4e-bd14-f294ce038902	2026-01-23	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: ENOXAPARIN SODIUM generic name: ENOXAPARIN SODIUM
enoxaparin sodium	ENOXAPARIN SODIUM	Hebei Changshan Biochemical Pharmaceutical Co., Ltd.	7fa78f8d-92d9-434a-8e26-b886ab0ae77f	2026-01-14	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: enoxaparin sodium generic name: ENOXAPARIN SODIUM
Enoxaparin Sodium	ENOXAPARIN SODIUM	Meitheal Pharmaceuticals Inc.	b6fb85ab-1fe5-4dd3-a97f-adbed0674f67	2026-01-08	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Enoxaparin Sodium generic name: ENOXAPARIN SODIUM
Enoxaparin Sodium	ENOXAPARIN SODIUM	Meitheal Pharmaceuticals Inc.	adbba7bb-fa72-4cec-aa69-13965591a45d	2025-12-17	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Enoxaparin Sodium generic name: ENOXAPARIN SODIUM
Enoxaparin Sodium	ENOXAPARIN SODIUM	BluePoint Laboratories	d978e06e-b758-460b-81d3-69f7a5b89b00	2025-09-30	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Enoxaparin Sodium generic name: ENOXAPARIN SODIUM
Enoxaparin Sodium	ENOXAPARIN SODIUM	BluePoint Laboratories	a2a8615b-a27e-4ab2-ae4c-592bbf4643c0	2025-09-29	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Enoxaparin Sodium generic name: ENOXAPARIN SODIUM
Enoxaparin Sodium	ENOXAPARIN SODIUM	Zydus Pharmaceuticals USA Inc.	d8afb29f-cbed-43bc-809f-09b30fca28f5	2024-12-06	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Enoxaparin Sodium generic name: ENOXAPARIN SODIUM
Enoxaparin Sodium	ENOXAPARIN SODIUM	NorthStar Rx LLC	32f8d292-0dda-4931-81ea-ba47e23edf61	2024-12-06	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Enoxaparin Sodium generic name: ENOXAPARIN SODIUM
Enoxaparin Sodium	ENOXAPARIN SODIUM	Meitheal Pharmaceuticals Inc.	7d38c307-767f-4c38-ac0e-b8bb62782602	2024-12-06	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Enoxaparin Sodium generic name: ENOXAPARIN SODIUM
Enoxaparin Sodium	ENOXAPARIN SODIUM	NorthStar RxLLC	014c6710-f2c4-fd1e-e063-6394a90ae525	2024-06-21	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Enoxaparin Sodium generic name: ENOXAPARIN SODIUM
Enoxaparin Sodium	ENOXAPARIN SODIUM	Sandoz Inc	38f60bd8-b518-4098-a808-b8f5a3ae6a3a	2024-06-06	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Enoxaparin Sodium generic name: ENOXAPARIN SODIUM

Reported adverse events (FAERS/openFDA)#

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