Application 020164

Type: NDA
Sponsor: SANOFI AVENTIS US

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	LOVENOX (PRESERVATIVE FREE)	ENOXAPARIN SODIUM	INJECTABLE;SUBCUTANEOUS	30MG/0.3ML (100MG/ML)	Yes	No
002	LOVENOX (PRESERVATIVE FREE)	ENOXAPARIN SODIUM	INJECTABLE;SUBCUTANEOUS	40MG/0.4ML (100MG/ML)	Yes	No
003	LOVENOX (PRESERVATIVE FREE)	ENOXAPARIN SODIUM	INJECTABLE;SUBCUTANEOUS	60MG/0.6ML (100MG/ML)	Yes	No
004	LOVENOX (PRESERVATIVE FREE)	ENOXAPARIN SODIUM	INJECTABLE;SUBCUTANEOUS	80MG/0.8ML (100MG/ML)	Yes	No
005	LOVENOX (PRESERVATIVE FREE)	ENOXAPARIN SODIUM	INJECTABLE;SUBCUTANEOUS	100MG/ML (100MG/ML)	Yes	Yes
006	LOVENOX (PRESERVATIVE FREE)	ENOXAPARIN SODIUM	INJECTABLE;SUBCUTANEOUS	90MG/0.6ML (150MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No
007	LOVENOX (PRESERVATIVE FREE)	ENOXAPARIN SODIUM	INJECTABLE;SUBCUTANEOUS	120MG/0.8ML (150MG/ML)	Yes	No
008	LOVENOX (PRESERVATIVE FREE)	ENOXAPARIN SODIUM	INJECTABLE;SUBCUTANEOUS	150MG/ML (150MG/ML)	Yes	No
009	LOVENOX	ENOXAPARIN SODIUM	INJECTABLE;INTRAVENOUS, SUBCUTANEOUS	300MG/3ML (100MG/ML)	Yes	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 9 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N020164-001	LOVENOX (PRESERVATIVE FREE)	ENOXAPARIN SODIUM	30MG/0.3ML (100MG/ML)	INJECTABLE / SUBCUTANEOUS	AP	RLD	1993-03-29
N020164-002	LOVENOX (PRESERVATIVE FREE)	ENOXAPARIN SODIUM	40MG/0.4ML (100MG/ML)	INJECTABLE / SUBCUTANEOUS	AP	RLD	1998-01-30
N020164-003	LOVENOX (PRESERVATIVE FREE)	ENOXAPARIN SODIUM	60MG/0.6ML (100MG/ML)	INJECTABLE / SUBCUTANEOUS	AP	RLD	1998-03-27
N020164-004	LOVENOX (PRESERVATIVE FREE)	ENOXAPARIN SODIUM	80MG/0.8ML (100MG/ML)	INJECTABLE / SUBCUTANEOUS	AP	RLD	1998-03-27
N020164-005	LOVENOX (PRESERVATIVE FREE)	ENOXAPARIN SODIUM	100MG/ML (100MG/ML)	INJECTABLE / SUBCUTANEOUS	AP	RLD, RS	1998-03-27
N020164-006	LOVENOX (PRESERVATIVE FREE)	ENOXAPARIN SODIUM	90MG/0.6ML (150MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / SUBCUTANEOUS		RLD	2000-06-02
N020164-007	LOVENOX (PRESERVATIVE FREE)	ENOXAPARIN SODIUM	120MG/0.8ML (150MG/ML)	INJECTABLE / SUBCUTANEOUS	AP	RLD	2000-06-02
N020164-008	LOVENOX (PRESERVATIVE FREE)	ENOXAPARIN SODIUM	150MG/ML (150MG/ML)	INJECTABLE / SUBCUTANEOUS	AP	RLD	2000-06-02
N020164-009	LOVENOX	ENOXAPARIN SODIUM	300MG/3ML (100MG/ML)	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS	AB	RLD	2003-01-23

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 8 matching rows.

Application-product, TE code table
Application-product	TE code
N020164-001	AP
N020164-002	AP
N020164-003	AP
N020164-004	AP
N020164-005	AP
N020164-007	AP
N020164-008	AP
N020164-009	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 10 · 378 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N020164-001	LOVENOX (PRESERVATIVE FREE)	30MG/0.3ML (100MG/ML)	INJECTABLE / SUBCUTANEOUS	AP	RLD	1993-03-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020164-002	LOVENOX (PRESERVATIVE FREE)	40MG/0.4ML (100MG/ML)	INJECTABLE / SUBCUTANEOUS	AP	RLD	1998-01-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020164-003	LOVENOX (PRESERVATIVE FREE)	60MG/0.6ML (100MG/ML)	INJECTABLE / SUBCUTANEOUS	AP	RLD	1998-03-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020164-004	LOVENOX (PRESERVATIVE FREE)	80MG/0.8ML (100MG/ML)	INJECTABLE / SUBCUTANEOUS	AP	RLD	1998-03-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020164-005	LOVENOX (PRESERVATIVE FREE)	100MG/ML (100MG/ML)	INJECTABLE / SUBCUTANEOUS	AP	RLD, RS	1998-03-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020164-006	LOVENOX (PRESERVATIVE FREE)	90MG/0.6ML (150MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / SUBCUTANEOUS		RLD	2000-06-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020164-007	LOVENOX (PRESERVATIVE FREE)	120MG/0.8ML (150MG/ML)	INJECTABLE / SUBCUTANEOUS	AP	RLD	2000-06-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020164-008	LOVENOX (PRESERVATIVE FREE)	150MG/ML (150MG/ML)	INJECTABLE / SUBCUTANEOUS	AP	RLD	2000-06-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020164-009	LOVENOX	300MG/3ML (100MG/ML)	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS	AB	RLD	2003-01-23	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N020164-001	LOVENOX (PRESERVATIVE FREE)	30MG/0.3ML (100MG/ML)	INJECTABLE / SUBCUTANEOUS	AP	RLD	1993-03-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020164-002	LOVENOX (PRESERVATIVE FREE)	40MG/0.4ML (100MG/ML)	INJECTABLE / SUBCUTANEOUS	AP	RLD	1998-01-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020164-003	LOVENOX (PRESERVATIVE FREE)	60MG/0.6ML (100MG/ML)	INJECTABLE / SUBCUTANEOUS	AP	RLD	1998-03-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020164-004	LOVENOX (PRESERVATIVE FREE)	80MG/0.8ML (100MG/ML)	INJECTABLE / SUBCUTANEOUS	AP	RLD	1998-03-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020164-005	LOVENOX (PRESERVATIVE FREE)	100MG/ML (100MG/ML)	INJECTABLE / SUBCUTANEOUS	AP	RLD, RS	1998-03-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020164-006	LOVENOX (PRESERVATIVE FREE)	90MG/0.6ML (150MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / SUBCUTANEOUS		RLD	2000-06-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020164-007	LOVENOX (PRESERVATIVE FREE)	120MG/0.8ML (150MG/ML)	INJECTABLE / SUBCUTANEOUS	AP	RLD	2000-06-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020164-008	LOVENOX (PRESERVATIVE FREE)	150MG/ML (150MG/ML)	INJECTABLE / SUBCUTANEOUS	AP	RLD	2000-06-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020164-009	LOVENOX	300MG/3ML (100MG/ML)	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS	AB	RLD	2003-01-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020164-001	LOVENOX (PRESERVATIVE FREE)	30MG/0.3ML (100MG/ML)	INJECTABLE / SUBCUTANEOUS	AP	RLD	1993-03-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020164-002	LOVENOX (PRESERVATIVE FREE)	40MG/0.4ML (100MG/ML)	INJECTABLE / SUBCUTANEOUS	AP	RLD	1998-01-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020164-003	LOVENOX (PRESERVATIVE FREE)	60MG/0.6ML (100MG/ML)	INJECTABLE / SUBCUTANEOUS	AP	RLD	1998-03-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020164-004	LOVENOX (PRESERVATIVE FREE)	80MG/0.8ML (100MG/ML)	INJECTABLE / SUBCUTANEOUS	AP	RLD	1998-03-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020164-005	LOVENOX (PRESERVATIVE FREE)	100MG/ML (100MG/ML)	INJECTABLE / SUBCUTANEOUS	AP	RLD, RS	1998-03-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020164-006	LOVENOX (PRESERVATIVE FREE)	90MG/0.6ML (150MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / SUBCUTANEOUS		RLD	2000-06-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020164-007	LOVENOX (PRESERVATIVE FREE)	120MG/0.8ML (150MG/ML)	INJECTABLE / SUBCUTANEOUS	AP	RLD	2000-06-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020164-008	LOVENOX (PRESERVATIVE FREE)	150MG/ML (150MG/ML)	INJECTABLE / SUBCUTANEOUS	AP	RLD	2000-06-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020164-009	LOVENOX	300MG/3ML (100MG/ML)	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS	AB	RLD	2003-01-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020164-001	LOVENOX (PRESERVATIVE FREE)	30MG/0.3ML (100MG/ML)	INJECTABLE / SUBCUTANEOUS	AP	RLD	1993-03-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020164-002	LOVENOX (PRESERVATIVE FREE)	40MG/0.4ML (100MG/ML)	INJECTABLE / SUBCUTANEOUS	AP	RLD	1998-01-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020164-003	LOVENOX (PRESERVATIVE FREE)	60MG/0.6ML (100MG/ML)	INJECTABLE / SUBCUTANEOUS	AP	RLD	1998-03-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020164-004	LOVENOX (PRESERVATIVE FREE)	80MG/0.8ML (100MG/ML)	INJECTABLE / SUBCUTANEOUS	AP	RLD	1998-03-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020164-005	LOVENOX (PRESERVATIVE FREE)	100MG/ML (100MG/ML)	INJECTABLE / SUBCUTANEOUS	AP	RLD, RS	1998-03-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020164-006	LOVENOX (PRESERVATIVE FREE)	90MG/0.6ML (150MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / SUBCUTANEOUS		RLD	2000-06-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020164-007	LOVENOX (PRESERVATIVE FREE)	120MG/0.8ML (150MG/ML)	INJECTABLE / SUBCUTANEOUS	AP	RLD	2000-06-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020164-008	LOVENOX (PRESERVATIVE FREE)	150MG/ML (150MG/ML)	INJECTABLE / SUBCUTANEOUS	AP	RLD	2000-06-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020164-009	LOVENOX	300MG/3ML (100MG/ML)	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS	AB	RLD	2003-01-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020164-001	LOVENOX (PRESERVATIVE FREE)	30MG/0.3ML (100MG/ML)	INJECTABLE / SUBCUTANEOUS	AP	RLD	1993-03-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020164-002	LOVENOX (PRESERVATIVE FREE)	40MG/0.4ML (100MG/ML)	INJECTABLE / SUBCUTANEOUS	AP	RLD	1998-01-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020164-003	LOVENOX (PRESERVATIVE FREE)	60MG/0.6ML (100MG/ML)	INJECTABLE / SUBCUTANEOUS	AP	RLD	1998-03-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020164-004	LOVENOX (PRESERVATIVE FREE)	80MG/0.8ML (100MG/ML)	INJECTABLE / SUBCUTANEOUS	AP	RLD	1998-03-27	`fd3edfee7708…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 9 · 336 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	N020164-001	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020164-002	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020164-003	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020164-004	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020164-005	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020164-007	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020164-008	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020164-009	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N020164-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020164-002	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020164-003	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020164-004	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020164-005	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020164-007	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020164-008	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020164-009	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020164-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020164-002	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020164-003	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020164-004	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020164-005	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020164-007	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020164-008	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020164-009	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020164-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020164-002	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020164-003	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020164-004	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020164-005	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020164-007	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020164-008	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020164-009	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020164-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020164-002	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020164-003	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020164-004	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020164-005	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020164-007	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020164-008	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020164-009	AB	1	`fd3edfee7708…`

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 1 · 6 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Lovenox	ENOXAPARIN SODIUM	Sanofi-Aventis U.S. LLC	5017a927-2a24-4f27-89f9-27c805bf7d59	2026-05-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 020164 application number: NDA020164
Lovenox	ENOXAPARIN SODIUM	Cardinal Health 107, LLC	3d263380-4f44-4fd8-aa2a-e69702ab258f	2026-04-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 020164 application number: NDA020164 ndc (product): 55154-4028
Lovenox	ENOXAPARIN SODIUM	Sanofi-Aventis U.S. LLC	de6fb917-a94a-41ea-9d7d-937d4080ffcd	2026-02-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 020164 application number: NDA020164 ndc (product): 0075-8030 ndc (product): 0075-8025
Enoxaparin sodium	ENOXAPARIN SODIUM	Sanofi-Aventis U.S. LLC	20635579-c92d-4f6c-a332-1096d51002f2	2026-02-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 020164 application number: NDA020164 ndc (product): 0955-1004 ndc (product): 0955-1006 ndc (product): 0955-1015 ndc (product): 0955-1012 ndc (product): 0955-1003 ndc (product): 0955-1016 ndc (product): 0955-1010 ndc (product): 0955-1008
Enoxaparin Sodium	ENOXAPARIN SODIUM	Fresenius Kabi USA, LLC	21b095d1-5ade-43e9-9114-30fbfb2331c9	2026-02-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 020164 application number: NDA020164 ndc (product): 63323-531
Enoxaparin Sodium	ENOXAPARIN SODIUM	Fresenius Kabi USA, LLC	066f27ec-352c-4051-ba29-248e292690db	2026-02-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 020164 application number: NDA020164 ndc (product): 63323-531

NDC Listings For This Application#

NDC listings for this application page 2 of 4 · 268 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0075-8025	Lovenox	enoxaparin sodium	Sanofi-Aventis U.S. LLC	NDA	Current
0075-8025	Lovenox	enoxaparin sodium	Sanofi-Aventis U.S. LLC	NDA	Current
0075-8025	Lovenox	enoxaparin sodium	Sanofi-Aventis U.S. LLC	NDA	Current
0075-8030	Lovenox	enoxaparin sodium	Sanofi-Aventis U.S. LLC	NDA	Current
0075-8030	Lovenox	enoxaparin sodium	sanofi-aventis U.S. LLC	NDA	Current
0075-8030	Lovenox	enoxaparin sodium	Sanofi-Aventis U.S. LLC	NDA	Current
0075-8030	Lovenox	enoxaparin sodium	Sanofi-Aventis U.S. LLC	NDA	Current
0075-8030	Lovenox	enoxaparin sodium	Sanofi-Aventis U.S. LLC	NDA	Current
0955-1003	Enoxaparin sodium	enoxaparin sodium	Winthrop U.S.	NDA AUTHORIZED GENERIC	Current
0955-1003	Enoxaparin sodium	enoxaparin sodium	Winthrop U.S.	NDA AUTHORIZED GENERIC	Current
0955-1003	Enoxaparin sodium	enoxaparin sodium	Winthrop U.S.	NDA AUTHORIZED GENERIC	Current
0955-1003	Enoxaparin sodium	enoxaparin sodium	Winthrop U.S.	NDA AUTHORIZED GENERIC	Current
0955-1003	Enoxaparin sodium	enoxaparin sodium	Winthrop U.S.	NDA AUTHORIZED GENERIC	Current
0955-1003	Enoxaparin sodium	enoxaparin sodium	Winthrop U.S.	NDA AUTHORIZED GENERIC	Current
0955-1004	Enoxaparin sodium	enoxaparin sodium	Winthrop U.S.	NDA AUTHORIZED GENERIC	Current
0955-1004	Enoxaparin sodium	enoxaparin sodium	Winthrop U.S.	NDA AUTHORIZED GENERIC	Current
0955-1004	Enoxaparin sodium	enoxaparin sodium	Winthrop U.S.	NDA AUTHORIZED GENERIC	Current
0955-1004	Enoxaparin sodium	enoxaparin sodium	Winthrop U.S.	NDA AUTHORIZED GENERIC	Current
0955-1004	Enoxaparin sodium	enoxaparin sodium	Winthrop U.S.	NDA AUTHORIZED GENERIC	Current
0955-1004	Enoxaparin sodium	enoxaparin sodium	Winthrop U.S.	NDA AUTHORIZED GENERIC	Current
0955-1006	Enoxaparin sodium	enoxaparin sodium	Winthrop U.S.	NDA AUTHORIZED GENERIC	Current
0955-1006	Enoxaparin sodium	enoxaparin sodium	Winthrop U.S.	NDA AUTHORIZED GENERIC	Current
0955-1006	Enoxaparin sodium	enoxaparin sodium	Winthrop U.S.	NDA AUTHORIZED GENERIC	Current
0955-1006	Enoxaparin sodium	enoxaparin sodium	Winthrop U.S.	NDA AUTHORIZED GENERIC	Current
0955-1006	Enoxaparin sodium	enoxaparin sodium	Winthrop U.S.	NDA AUTHORIZED GENERIC	Current
0955-1006	Enoxaparin sodium	enoxaparin sodium	Winthrop U.S.	NDA AUTHORIZED GENERIC	Current
0955-1008	Enoxaparin sodium	enoxaparin sodium	Winthrop U.S.	NDA AUTHORIZED GENERIC	Current
0955-1008	Enoxaparin sodium	enoxaparin sodium	Winthrop U.S.	NDA AUTHORIZED GENERIC	Current
0955-1008	Enoxaparin sodium	enoxaparin sodium	Winthrop U.S.	NDA AUTHORIZED GENERIC	Current
0955-1008	Enoxaparin sodium	enoxaparin sodium	Winthrop U.S.	NDA AUTHORIZED GENERIC	Current
0955-1008	Enoxaparin sodium	enoxaparin sodium	Winthrop U.S.	NDA AUTHORIZED GENERIC	Current
0955-1008	Enoxaparin sodium	enoxaparin sodium	Winthrop U.S.	NDA AUTHORIZED GENERIC	Current
0955-1010	Enoxaparin sodium	enoxaparin sodium	Winthrop U.S.	NDA AUTHORIZED GENERIC	Current
0955-1010	Enoxaparin sodium	enoxaparin sodium	Winthrop U.S.	NDA AUTHORIZED GENERIC	Current
0955-1010	Enoxaparin sodium	enoxaparin sodium	Winthrop U.S.	NDA AUTHORIZED GENERIC	Current
0955-1010	Enoxaparin sodium	enoxaparin sodium	Winthrop U.S.	NDA AUTHORIZED GENERIC	Current
0955-1010	Enoxaparin sodium	enoxaparin sodium	Winthrop U.S.	NDA AUTHORIZED GENERIC	Current
0955-1010	Enoxaparin sodium	enoxaparin sodium	Winthrop U.S.	NDA AUTHORIZED GENERIC	Current
0955-1012	Enoxaparin sodium	enoxaparin sodium	Winthrop U.S.	NDA AUTHORIZED GENERIC	Current
0955-1012	Enoxaparin sodium	enoxaparin sodium	Winthrop U.S.	NDA AUTHORIZED GENERIC	Current
0955-1012	Enoxaparin sodium	enoxaparin sodium	Winthrop U.S.	NDA AUTHORIZED GENERIC	Current
0955-1012	Enoxaparin sodium	enoxaparin sodium	Winthrop U.S.	NDA AUTHORIZED GENERIC	Current
0955-1012	Enoxaparin sodium	enoxaparin sodium	Winthrop U.S.	NDA AUTHORIZED GENERIC	Current
0955-1012	Enoxaparin sodium	enoxaparin sodium	Winthrop U.S.	NDA AUTHORIZED GENERIC	Current
0955-1015	Enoxaparin sodium	enoxaparin sodium	Winthrop U.S.	NDA AUTHORIZED GENERIC	Current
0955-1015	Enoxaparin sodium	enoxaparin sodium	Winthrop U.S.	NDA AUTHORIZED GENERIC	Current
0955-1015	Enoxaparin sodium	enoxaparin sodium	Winthrop U.S.	NDA AUTHORIZED GENERIC	Current
0955-1015	Enoxaparin sodium	enoxaparin sodium	Winthrop U.S.	NDA AUTHORIZED GENERIC	Current
0955-1015	Enoxaparin sodium	enoxaparin sodium	Winthrop U.S.	NDA AUTHORIZED GENERIC	Current
0955-1015	Enoxaparin sodium	enoxaparin sodium	Winthrop U.S.	NDA AUTHORIZED GENERIC	Current
0955-1016	Enoxaparin sodium	enoxaparin sodium	Winthrop U.S.	NDA AUTHORIZED GENERIC	Current
0955-1016	Enoxaparin sodium	enoxaparin sodium	Winthrop U.S.	NDA AUTHORIZED GENERIC	Current
0955-1016	Enoxaparin sodium	enoxaparin sodium	Winthrop U.S.	NDA AUTHORIZED GENERIC	Current
0955-1016	Enoxaparin sodium	enoxaparin sodium	Winthrop U.S.	NDA AUTHORIZED GENERIC	Current
0955-1016	Enoxaparin sodium	enoxaparin sodium	Winthrop U.S.	NDA AUTHORIZED GENERIC	Current
0955-1016	Enoxaparin sodium	enoxaparin sodium	Winthrop U.S.	NDA AUTHORIZED GENERIC	Current
55154-4024	Lovenox	enoxaparin sodium	Cardinal Health	NDA	Current
55154-4024	Lovenox	enoxaparin sodium	Cardinal Health	NDA	Current
55154-4028	Lovenox	enoxaparin sodium	Cardinal Health	NDA	Current
55154-4028	Lovenox	enoxaparin sodium	Cardinal Health	NDA	Current
55154-4028	Lovenox	enoxaparin sodium	Cardinal Health	NDA	Current
55154-4028	Lovenox	enoxaparin sodium	Cardinal Health	NDA	Current
55154-9399	Enoxaparin sodium	enoxaparin sodium	Cardinal Health	NDA AUTHORIZED GENERIC	Current
55154-9399	Enoxaparin sodium	enoxaparin sodium	Cardinal Health	NDA AUTHORIZED GENERIC	Current
55154-9399	Enoxaparin sodium	enoxaparin sodium	Cardinal Health	NDA AUTHORIZED GENERIC	Current
55154-9576	Enoxaparin sodium	enoxaparin sodium	Cardinal Health	NDA AUTHORIZED GENERIC	Current
55154-9576	Enoxaparin sodium	enoxaparin sodium	Cardinal Health	NDA AUTHORIZED GENERIC	Current
55154-9578	Enoxaparin sodium	enoxaparin sodium	Cardinal Health	NDA AUTHORIZED GENERIC	Current
55154-9578	Enoxaparin sodium	enoxaparin sodium	Cardinal Health	NDA AUTHORIZED GENERIC	Current
55154-9578	Enoxaparin sodium	enoxaparin sodium	Cardinal Health	NDA AUTHORIZED GENERIC	Current
55154-9579	Enoxaparin sodium	enoxaparin sodium	Cardinal Health	NDA AUTHORIZED GENERIC	Current
55154-9579	Enoxaparin sodium	enoxaparin sodium	Cardinal Health	NDA AUTHORIZED GENERIC	Current
55154-9579	Enoxaparin sodium	enoxaparin sodium	Cardinal Health	NDA AUTHORIZED GENERIC	Current
55154-9579	Enoxaparin sodium	enoxaparin sodium	Cardinal Health	NDA AUTHORIZED GENERIC	Current
55154-9580	Enoxaparin sodium	enoxaparin sodium	Cardinal Health	NDA AUTHORIZED GENERIC	Current
55154-9580	Enoxaparin sodium	enoxaparin sodium	Cardinal Health	NDA AUTHORIZED GENERIC	Current
55154-9580	Enoxaparin sodium	enoxaparin sodium	Cardinal Health	NDA AUTHORIZED GENERIC	Current
55154-9580	Enoxaparin sodium	enoxaparin sodium	Cardinal Health	NDA AUTHORIZED GENERIC	Current
63323-531	Enoxaparin Sodium	enoxaparin sodium	Fresenius Kabi USA, LLC	NDA AUTHORIZED GENERIC	Current
63323-531	Enoxaparin Sodium	enoxaparin sodium	Fresenius Kabi USA, LLC	NDA AUTHORIZED GENERIC	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
74941	SUPPL	2023-07-31
74940	SUPPL	2023-07-31
72775	SUPPL	2022-12-05
72770	SUPPL	2022-12-02
69729	SUPPL	2021-12-21
69699	SUPPL	2021-12-20
56839	SUPPL	2018-12-20
56710	SUPPL	2018-12-12
50280	SUPPL	2017-11-03
50238	SUPPL	2017-10-31
44049	ORIG	2013-11-07
34335	SUPPL	2013-10-31
21249	SUPPL	2013-10-25
34334	SUPPL	2013-06-11
2128	SUPPL	2013-06-07
2127	SUPPL	2011-04-22
12290	SUPPL	2011-04-21
34333	SUPPL	2011-04-19
2126	SUPPL	2011-04-15
21248	SUPPL	2009-12-31
12289	SUPPL	2009-12-30
21247	SUPPL	2009-07-31
34332	SUPPL	2009-07-30
20515	SUPPL	2009-03-24
41182	SUPPL	2008-08-11
20506	SUPPL	2008-08-11
20505	SUPPL	2008-08-11
20504	SUPPL	2008-08-11
20503	SUPPL	2008-08-11
41188	SUPPL	2008-08-08
41187	SUPPL	2008-08-08
41186	SUPPL	2008-08-08
41184	SUPPL	2008-08-08
20509	SUPPL	2008-08-08
20508	SUPPL	2008-08-08
20507	SUPPL	2008-08-08
41197	SUPPL	2008-08-04
41196	SUPPL	2008-08-04
41195	SUPPL	2008-08-04
41194	SUPPL	2008-08-04
41193	SUPPL	2008-08-04
41192	SUPPL	2008-08-04
41191	SUPPL	2008-08-04
41190	SUPPL	2008-08-04
41189	SUPPL	2008-08-04
20511	SUPPL	2008-08-04
41198	SUPPL	2008-08-01
20514	SUPPL	2008-08-01
20512	SUPPL	2008-08-01
20510	SUPPL	2008-08-01
12288	SUPPL	2008-07-22
21246	SUPPL	2008-07-18
41200	SUPPL	2007-07-09
41199	SUPPL	2007-07-09
21245	SUPPL	2007-05-29
12287	SUPPL	2007-05-29
34331	SUPPL	2007-01-16
2125	SUPPL	2007-01-16
20513	SUPPL	2006-10-26
2124	SUPPL	2005-03-10
21241	SUPPL	2004-10-26
21242	SUPPL	2004-07-28
12286	SUPPL	2004-07-28
20502	ORIG	2004-07-15
2114	SUPPL	2004-06-08
2123	SUPPL	2004-05-26
21244	SUPPL	2004-04-29
21243	SUPPL	2004-04-20
34328	ORIG	2004-04-05
21236	ORIG	2004-02-25
2120	SUPPL	2003-12-23
2121	SUPPL	2003-07-08
2122	SUPPL	2003-07-06
41183	SUPPL	2003-04-29
21239	SUPPL	2003-01-23
21240	SUPPL	2002-01-09
21238	SUPPL	2002-01-09
2119	SUPPL	2002-01-09
34330	SUPPL	2000-11-17
21237	SUPPL	2000-11-17
12285	SUPPL	2000-11-17
2118	SUPPL	2000-11-17
2117	SUPPL	2000-09-27
2116	SUPPL	2000-08-04
41185	SUPPL	2000-07-03
34329	SUPPL	1998-12-31
2115	SUPPL	1998-12-31