Application 021081

Type: NDA
Sponsor: SANOFI AVENTIS US

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	LANTUS	INSULIN GLARGINE RECOMBINANT	INJECTABLE;INJECTION	100 UNITS/ML	Yes	Yes
002	LANTUS SOLOSTAR	INSULIN GLARGINE RECOMBINANT	INJECTABLE;INJECTION	300 UNITS/3ML (100 UNITS/ML)	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog.

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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N021081-001	LANTUS	100 UNITS/ML	INJECTABLE / INJECTION	RLD, RS	2000-04-20	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021081-002	LANTUS SOLOSTAR	300 UNITS/3ML (100 UNITS/ML)	INJECTABLE / INJECTION	RLD, RS	2007-04-27	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	N021081-001	LANTUS	100 UNITS/ML	INJECTABLE / INJECTION	RLD, RS	2000-04-20	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021081-002	LANTUS SOLOSTAR	300 UNITS/3ML (100 UNITS/ML)	INJECTABLE / INJECTION	RLD, RS	2007-04-27	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021081-001	LANTUS	100 UNITS/ML	INJECTABLE / INJECTION	RLD, RS	2000-04-20	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021081-002	LANTUS SOLOSTAR	300 UNITS/3ML (100 UNITS/ML)	INJECTABLE / INJECTION	RLD, RS	2007-04-27	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021081-001	LANTUS	100 UNITS/ML	INJECTABLE / INJECTION	RLD, RS	2000-04-20	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N021081-002	LANTUS SOLOSTAR	300 UNITS/3ML (100 UNITS/ML)	INJECTABLE / INJECTION	RLD, RS	2007-04-27	`ea99ee380514…`

Observed Orange Book patent history#

Patent history page 1 of 3 · 96 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N021081-001	7713930	2023-06-13		Drug product		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021081-001	7476652	2023-07-23		Drug product		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021081-001	7713930*PED	2023-12-13		Pediatric extension		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021081-001	7476652*PED	2024-01-23		Pediatric extension		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021081-001	7918833	2027-09-23		Drug product		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021081-001	7918833*PED	2028-03-23		Pediatric extension		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021081-002	8603044	2024-03-02		Drug product	2014-01-06	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021081-002	9233211	2024-03-02		Drug product	2016-01-13	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021081-002	9408979	2024-03-02		Drug product	2016-09-15	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021081-002	9526844	2024-03-02		Drug product	2016-12-27	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021081-002	9604008	2024-03-02		Drug product	2017-03-28	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021081-002	9610409	2024-03-02		Drug product	2017-04-04	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021081-002	9775954	2024-03-02		Drug product	2017-10-03	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021081-002	9827379	2024-03-02	U-2146	Drug product	2017-11-28	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021081-002	8556864	2024-03-03		Drug product	2013-11-06	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021081-002	9011391	2024-03-26	U-1832		2015-05-01	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021081-002	8992486	2024-06-05		Drug product	2015-04-09	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021081-002	9604009	2024-08-16		Drug product	2017-03-28	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021081-002	9533105	2024-08-17		Drug product	2017-01-03	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021081-002	9623189	2024-08-19		Drug product	2017-04-18	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021081-002	9561331	2024-08-28		Drug product	2017-02-07	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021081-002	8512297	2024-09-15		Drug product	2013-08-21	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021081-002	8679069	2025-04-12		Drug product	2014-03-25	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021081-002	9717852	2033-04-08		Drug product	2018-07-11	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	N021081-001	7713930	2023-06-13		Drug product		`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021081-001	7476652	2023-07-23		Drug product		`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021081-001	7713930*PED	2023-12-13		Pediatric extension		`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021081-001	7476652*PED	2024-01-23		Pediatric extension		`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021081-001	7918833	2027-09-23		Drug product		`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021081-001	7918833*PED	2028-03-23		Pediatric extension		`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021081-002	8603044	2024-03-02		Drug product	2014-01-06	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021081-002	9233211	2024-03-02		Drug product	2016-01-13	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021081-002	9408979	2024-03-02		Drug product	2016-09-15	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021081-002	9526844	2024-03-02		Drug product	2016-12-27	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021081-002	9604008	2024-03-02		Drug product	2017-03-28	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021081-002	9610409	2024-03-02		Drug product	2017-04-04	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021081-002	9775954	2024-03-02		Drug product	2017-10-03	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021081-002	9827379	2024-03-02	U-2146	Drug product	2017-11-28	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021081-002	8556864	2024-03-03		Drug product	2013-11-06	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021081-002	9011391	2024-03-26	U-1832		2015-05-01	`3f01610625f2…`

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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Lantus Solostar	INSULIN GLARGINE	sanofi-aventis U.S. LLC	d5e07a0c-7e14-4756-9152-9fea485d654a	2025-06-02	Warnings, Adverse reactions	Exact identifier ndc (product): 0088-2219 ndc (product): 0088-2220
Insulin Glargine Solostar	INSULIN GLARGINE	A-S Medication Solutions	9835904f-64f5-42b3-9ac9-89e4aaa5182a	2023-11-01	Warnings, Adverse reactions	Exact identifier ndc (product): 50090-6178
LANTUS SOLOSTAR	INSULIN GLARGINE	A-S Medication Solutions	3a97c40f-0c83-42d7-a8ee-484b208db4e3	2023-07-22	Warnings, Adverse reactions	Exact identifier ndc (product): 50090-4068
Lantus Solostar	INSULIN GLARGINE	A-S Medication Solutions	632d9f68-f184-43d5-b184-a3af23f12ad9	2023-06-06	Warnings, Adverse reactions	Exact identifier ndc (product): 50090-1398
Lantus	INSULIN GLARGINE	A-S Medication Solutions	ae27bb66-5dbe-4f01-a89e-f4fa7cb09c99	2023-02-04	Warnings, Adverse reactions	Exact identifier ndc (product): 50090-0876

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 54 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0088-2219	Lantus Solostar	insulin glargine	sanofi-aventis U.S. LLC	BLA	Current
0088-2219	Lantus Solostar	insulin glargine	sanofi-aventis U.S. LLC	NDA	Current
0088-2219	Lantus Solostar	insulin glargine	sanofi-aventis U.S. LLC	BLA	Current
0088-2219	Lantus Solostar	insulin glargine	sanofi-aventis U.S. LLC	NDA	Current
0088-2219	Lantus Solostar	insulin glargine	sanofi-aventis U.S. LLC	BLA	Current
0088-2219	Lantus Solostar	insulin glargine	sanofi-aventis U.S. LLC	BLA	Current
0088-2219	Lantus Solostar	insulin glargine	sanofi-aventis U.S. LLC	NDA	Current
0088-2219	Lantus Solostar	insulin glargine	sanofi-aventis U.S. LLC	NDA	Current
0088-2219	Lantus Solostar	insulin glargine	sanofi-aventis U.S. LLC	NDA	Current
0088-2220	Lantus	insulin glargine	sanofi-aventis U.S. LLC	BLA	Current
0088-2220	Lantus	insulin glargine	sanofi-aventis U.S. LLC	NDA	Current
0088-2220	Lantus	insulin glargine	sanofi-aventis U.S. LLC	BLA	Current
0088-2220	Lantus	insulin glargine	sanofi-aventis U.S. LLC	NDA	Current
0088-2220	Lantus	insulin glargine	sanofi-aventis U.S. LLC	BLA	Current
0088-2220	Lantus	insulin glargine	sanofi-aventis U.S. LLC	BLA	Current
0088-2220	Lantus	insulin glargine	sanofi-aventis U.S. LLC	NDA	Current
0088-2220	Lantus	insulin glargine	sanofi-aventis U.S. LLC	NDA	Current
0088-2220	Lantus	insulin glargine	sanofi-aventis U.S. LLC	NDA	Current
0088-5020	Lantus Solostar	insulin glargine	sanofi-aventis U.S. LLC	BLA	Current
0088-5020	Lantus Solostar	insulin glargine	sanofi-aventis U.S. LLC	NDA	Current
0088-5020	Lantus Solostar	insulin glargine	sanofi-aventis U.S. LLC	NDA	Current
0088-5020	Lantus Solostar	insulin glargine	sanofi-aventis U.S. LLC	BLA	Current
0088-5020	Lantus Solostar	insulin glargine	sanofi-aventis U.S. LLC	BLA	Current
0088-5020	Lantus Solostar	insulin glargine	sanofi-aventis U.S. LLC	NDA	Current
0088-5020	Lantus Solostar	insulin glargine	sanofi-aventis U.S. LLC	NDA	Current
0088-5020	Lantus Solostar	insulin glargine	sanofi-aventis U.S. LLC	BLA	Current
0088-5020	Lantus Solostar	insulin glargine	sanofi-aventis U.S. LLC	NDA	Current
0088-5021	Lantus	insulin glargine	sanofi-aventis U.S. LLC	BLA	Current
0088-5021	Lantus	insulin glargine	sanofi-aventis U.S. LLC	NDA	Current
0088-5021	Lantus	insulin glargine	sanofi-aventis U.S. LLC	NDA	Current
0088-5021	Lantus	insulin glargine	sanofi-aventis U.S. LLC	BLA	Current
0088-5021	Lantus	insulin glargine	sanofi-aventis U.S. LLC	BLA	Current
0088-5021	Lantus	insulin glargine	sanofi-aventis U.S. LLC	NDA	Current
0088-5021	Lantus	insulin glargine	sanofi-aventis U.S. LLC	NDA	Current
0088-5021	Lantus	insulin glargine	sanofi-aventis U.S. LLC	BLA	Current
0088-5021	Lantus	insulin glargine	sanofi-aventis U.S. LLC	NDA	Current
0955-1728	Insulin Glargine Solostar	insulin glargine	Winthrop U.S.	BLA	Current
0955-1728	Insulin Glargine Solostar	insulin glargine	Winthrop U.S.	BLA	Current
0955-1729	Insulin Glargine	insulin glargine	Winthrop U.S.	BLA	Current
0955-1729	Insulin Glargine	insulin glargine	Winthrop U.S.	BLA	Current
12854-432	Insulin Glargine Solostar	insulin glargine	Sanofi-Aventis Deutschland GmbH	BLA	Current
12854-433	Insulin Glargine	insulin glargine	Sanofi-Aventis Deutschland GmbH	BLA	Current
50090-0876	Lantus	insulin glargine	A-S Medication Solutions	NDA	Current
50090-0876	Lantus	insulin glargine	A-S Medication Solutions	BLA	Current
50090-1398	Lantus Solostar	insulin glargine	A-S Medication Solutions	BLA	Current
50090-1398	Lantus Solostar	insulin glargine	A-S Medication Solutions	NDA	Current
50090-4068	Lantus Solostar	insulin glargine	A-S Medication Solutions	BLA	Current
50090-6178	Insulin Glargine Solostar	insulin glargine	A-S Medication Solutions	BLA	Current
50090-6184	Insulin Glargine	insulin glargine	A-S Medication Solutions	BLA	Current
55045-3685	Lantus	insulin glargine	Dispensing Solutions, Inc.	NDA	Current
64725-2220	Lantus	insulin glargine	TYA Pharmaceuticals	NDA	Current
70518-1390	Lantus Solostar	insulin glargine	REMEDYREPACK INC.	NDA	Current
70518-1390	Lantus Solostar	insulin glargine	REMEDYREPACK INC.	BLA	Current
70518-1865	Lantus	insulin glargine	REMEDYREPACK INC.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
74674	SUPPL	2023-06-30
74673	SUPPL	2023-06-30
74672	SUPPL	2023-06-30
74671	SUPPL	2023-06-30
71258	SUPPL	2022-06-08
71252	SUPPL	2022-06-08
62378	APPL	2020-03-31
60960	SUPPL	2020-03-23
60959	SUPPL	2020-03-23
60909	SUPPL	2020-03-23
60908	SUPPL	2020-03-23
58646	SUPPL	2020-03-23
58638	SUPPL	2020-03-23
57207	SUPPL	2020-03-23
56817	SUPPL	2020-03-23
56597	SUPPL	2020-03-23
41938	SUPPL	2020-03-23
41937	SUPPL	2020-03-23
41936	ORIG	2020-03-23
36040	SUPPL	2020-03-23
36039	SUPPL	2020-03-23
36038	SUPPL	2020-03-23
36037	SUPPL	2020-03-23
36036	SUPPL	2020-03-23
36035	SUPPL	2020-03-23
36034	ORIG	2020-03-23
26679	SUPPL	2020-03-23
26678	SUPPL	2020-03-23
26677	SUPPL	2020-03-23
26676	SUPPL	2020-03-23
26675	SUPPL	2020-03-23
26674	SUPPL	2020-03-23
26673	SUPPL	2020-03-23
26672	SUPPL	2020-03-23
26671	ORIG	2020-03-23
23624	ORIG	2020-03-23
21426	SUPPL	2020-03-23
14314	SUPPL	2020-03-23
14313	SUPPL	2020-03-23
14312	SUPPL	2020-03-23
14311	SUPPL	2020-03-23
4241	SUPPL	2020-03-23
4240	SUPPL	2020-03-23