Application 020496

Type: NDA
Sponsor: SANOFI AVENTIS US

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	AMARYL	GLIMEPIRIDE	TABLET;ORAL	1MG	Yes	Yes
002	AMARYL	GLIMEPIRIDE	TABLET;ORAL	2MG	Yes	No
003	AMARYL	GLIMEPIRIDE	TABLET;ORAL	4MG	Yes	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS	Approval date
N020496-001	AMARYL	GLIMEPIRIDE	1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1995-11-30
N020496-002	AMARYL	GLIMEPIRIDE	2MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1995-11-30
N020496-003	AMARYL	GLIMEPIRIDE	4MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1995-11-30

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 4 · 129 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
2026-09-14 22:38:34	2026-08	N020496-001	AMARYL	1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1995-11-30	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N020496-002	AMARYL	2MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1995-11-30	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N020496-003	AMARYL	4MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1995-11-30	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N020496-001	AMARYL	1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1995-11-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020496-002	AMARYL	2MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1995-11-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020496-003	AMARYL	4MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1995-11-30	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N020496-001	AMARYL	1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1995-11-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020496-002	AMARYL	2MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1995-11-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020496-003	AMARYL	4MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1995-11-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020496-001	AMARYL	1MG	TABLET / ORAL		RLD	1995-11-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020496-002	AMARYL	2MG	TABLET / ORAL		RLD	1995-11-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020496-003	AMARYL	4MG	TABLET / ORAL		RLD	1995-11-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020496-001	AMARYL	1MG	TABLET / ORAL		RLD	1995-11-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020496-002	AMARYL	2MG	TABLET / ORAL		RLD	1995-11-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020496-003	AMARYL	4MG	TABLET / ORAL		RLD	1995-11-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020496-001	AMARYL	1MG	TABLET / ORAL		RLD	1995-11-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020496-002	AMARYL	2MG	TABLET / ORAL		RLD	1995-11-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020496-003	AMARYL	4MG	TABLET / ORAL		RLD	1995-11-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020496-001	AMARYL	1MG	TABLET / ORAL	AB	RLD, RS	1995-11-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020496-002	AMARYL	2MG	TABLET / ORAL	AB	RLD	1995-11-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020496-003	AMARYL	4MG	TABLET / ORAL	AB	RLD	1995-11-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020496-001	AMARYL	1MG	TABLET / ORAL	AB	RLD, RS	1995-11-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020496-002	AMARYL	2MG	TABLET / ORAL	AB	RLD	1995-11-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020496-003	AMARYL	4MG	TABLET / ORAL	AB	RLD	1995-11-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020496-001	AMARYL	1MG	TABLET / ORAL	AB	RLD, RS	1995-11-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020496-002	AMARYL	2MG	TABLET / ORAL	AB	RLD	1995-11-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020496-003	AMARYL	4MG	TABLET / ORAL	AB	RLD	1995-11-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020496-001	AMARYL	1MG	TABLET / ORAL	AB	RLD, RS	1995-11-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020496-002	AMARYL	2MG	TABLET / ORAL	AB	RLD	1995-11-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020496-003	AMARYL	4MG	TABLET / ORAL	AB	RLD	1995-11-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020496-001	AMARYL	1MG	TABLET / ORAL	AB	RLD, RS	1995-11-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020496-002	AMARYL	2MG	TABLET / ORAL	AB	RLD	1995-11-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020496-003	AMARYL	4MG	TABLET / ORAL	AB	RLD	1995-11-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020496-001	AMARYL	1MG	TABLET / ORAL	AB	RLD, RS	1995-11-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020496-002	AMARYL	2MG	TABLET / ORAL	AB	RLD	1995-11-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020496-003	AMARYL	4MG	TABLET / ORAL	AB	RLD	1995-11-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020496-001	AMARYL	1MG	TABLET / ORAL	AB	RLD, RS	1995-11-30	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020496-002	AMARYL	2MG	TABLET / ORAL	AB	RLD	1995-11-30	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020496-003	AMARYL	4MG	TABLET / ORAL	AB	RLD	1995-11-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020496-001	AMARYL	1MG	TABLET / ORAL	AB	RLD, RS	1995-11-30	`301d65b070ca…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 108 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020496-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020496-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020496-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020496-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020496-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020496-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020496-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020496-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020496-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020496-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020496-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020496-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020496-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020496-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020496-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020496-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020496-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020496-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020496-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020496-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020496-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020496-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020496-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020496-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020496-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020496-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020496-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020496-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N020496-002	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N020496-003	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020496-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020496-002	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020496-003	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020496-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N020496-002	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N020496-003	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020496-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N020496-002	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N020496-003	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020496-001	AB	1	`74a2ff9319b5…`

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 4 · 71 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Glimepiride	GLIMEPIRIDE	Northwind Health Company, LLC	f3184cd3-df99-db32-e053-2995a90aa573	2026-01-01	Warnings, Adverse reactions	Name fallback generic name: GLIMEPIRIDE
Glimepiride	GLIMEPIRIDE	Northwind Health Company, LLC	dae404ac-881a-14d8-e053-2995a90acd41	2026-01-01	Warnings, Adverse reactions	Name fallback generic name: GLIMEPIRIDE
Glimepiride	GLIMEPIRIDE	Northwind Health Company, LLC	3e81a39a-30bb-4d6d-82e1-17d7134365be	2026-01-01	Warnings, Adverse reactions	Name fallback generic name: GLIMEPIRIDE
Glimepiride	GLIMEPIRIDE	Northwind Health Company, LLC	f2f2d6da-eb40-4290-e053-2a95a90a6ca0	2026-01-01	Warnings, Adverse reactions	Name fallback generic name: GLIMEPIRIDE
Glimepiride	GLIMEPIRIDE	A-S Medication Solutions	b6ce0eea-149d-4aed-a615-0b1c8f3f6a8e	2025-12-30	Warnings, Adverse reactions	Name fallback generic name: GLIMEPIRIDE
Glimepiride	GLIMEPIRIDE	Northwind Health Company, LLC	10a36c79-1b24-46b7-e063-6294a90a8dca	2025-12-26	Warnings, Adverse reactions	Name fallback generic name: GLIMEPIRIDE
Glimepiride	GLIMEPIRIDE	Accord Healthcare Inc	9b74fbac-9e04-4927-9981-1e3dace89c6d	2025-10-17	Warnings, Adverse reactions	Name fallback generic name: GLIMEPIRIDE
Glimepiride	GLIMEPIRIDE	PD-Rx Pharmaceuticals, Inc.	101cdc41-2131-4425-b550-6a0a60b5f4a4	2025-10-15	Warnings, Adverse reactions	Name fallback generic name: GLIMEPIRIDE
Glimepiride	GLIMEPIRIDE	PD-Rx Pharmaceuticals, Inc.	657f1b51-2f82-44f6-a23d-97f4b34b3c45	2025-10-15	Warnings, Adverse reactions	Name fallback generic name: GLIMEPIRIDE
Glimepiride	GLIMEPIRIDE	A-S Medication Solutions	489dc098-0ac7-4f8e-b258-326229539c7c	2025-08-15	Warnings, Adverse reactions	Name fallback generic name: GLIMEPIRIDE
Glimepiride	GLIMEPIRIDE	A-S Medication Solutions	be7175ae-ba53-45b8-9554-e4f4ebf56883	2025-08-15	Warnings, Adverse reactions	Name fallback generic name: GLIMEPIRIDE
Glimepiride	GLIMEPIRIDE	BluePoint Laboratories	a01b0466-13f5-4c47-ae55-c5f1527d9414	2025-07-07	Warnings, Adverse reactions	Name fallback generic name: GLIMEPIRIDE
Glimepiride	GLIMEPIRIDE	Bryant Ranch Prepack	d4513181-4558-4d9a-851b-acf7e3eda25a	2025-06-16	Warnings, Adverse reactions	Name fallback generic name: GLIMEPIRIDE
Glimepiride	GLIMEPIRIDE	ST. MARY'S MEDICAL PARK PHARMACY	35ba31ef-2b90-61c6-e063-6394a90a59ee	2025-05-22	Warnings, Adverse reactions	Name fallback generic name: GLIMEPIRIDE
Glimepiride	GLIMEPIRIDE	Micro Labs Limited	60e9397e-83b9-489e-9683-6f87e458bbaa	2025-05-12	Warnings, Adverse reactions	Name fallback generic name: GLIMEPIRIDE
Glimepiride	GLIMEPIRIDE	A-S Medication Solutions	49bf2d48-efa8-487b-b861-0124c3a4c951	2025-04-01	Warnings, Adverse reactions	Name fallback generic name: GLIMEPIRIDE
Glimepiride	GLIMEPIRIDE	PD-Rx Pharmaceuticals, Inc.	f4ffb19e-6d65-49fd-83ce-514d38d9d97c	2025-02-04	Warnings, Adverse reactions	Name fallback generic name: GLIMEPIRIDE
Glimepiride	GLIMEPIRIDE	Bryant Ranch Prepack	661b5b13-6334-4965-8dc5-709e19080584	2025-01-28	Warnings, Adverse reactions	Name fallback generic name: GLIMEPIRIDE
Glimepiride	GLIMEPIRIDE	Direct_Rx	fd26934e-daea-f47b-e053-6394a90a4bc6	2025-01-22	Warnings, Adverse reactions	Name fallback generic name: GLIMEPIRIDE
Glimepiride	GLIMEPIRIDE	PD-Rx Pharmaceuticals, Inc.	11ae3189-6139-4470-95d5-72abc0f5b0d0	2025-01-08	Warnings, Adverse reactions	Name fallback generic name: GLIMEPIRIDE

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 · 6 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0039-0221	AMARYL	glimepiride	Sanofi-Aventis U.S. LLC	NDA	Current
0039-0221	AMARYL	glimepiride	Sanofi-Aventis U.S. LLC	NDA	Current
0039-0222	AMARYL	glimepiride	Sanofi-Aventis U.S. LLC	NDA	Current
0039-0222	AMARYL	glimepiride	Sanofi-Aventis U.S. LLC	NDA	Current
0039-0223	AMARYL	glimepiride	Sanofi-Aventis U.S. LLC	NDA	Current
0039-0223	AMARYL	glimepiride	Sanofi-Aventis U.S. LLC	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
57651	ORIG	2019-02-15
57073	SUPPL	2018-12-31
57013	SUPPL	2018-12-26
46490	SUPPL	2016-12-22
46494	SUPPL	2016-12-21
12637	SUPPL	2013-10-22
25049	SUPPL	2013-10-18
12636	SUPPL	2013-08-09
25048	SUPPL	2013-08-05
25047	SUPPL	2012-02-08
34713	SUPPL	2012-02-06
25046	SUPPL	2009-06-16
34712	SUPPL	2009-06-04
25045	SUPPL	2009-02-13
2603	SUPPL	2009-02-13
34711	SUPPL	2009-02-04
12635	SUPPL	2009-02-04
25044	SUPPL	2005-12-06
34709	SUPPL	2005-12-05
34710	SUPPL	2005-09-22
2602	SUPPL	2005-09-22
25043	SUPPL	2004-08-25
20684	SUPPL	2004-05-27
2601	SUPPL	2002-04-15
20683	SUPPL	1999-02-24
2600	SUPPL	1999-02-24
51967	SUPPL	1900-01-01
51966	SUPPL	1900-01-01
51965	SUPPL	1900-01-01