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N020496-001	AMARYL	GLIMEPIRIDE	1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1995-11-30
N020496-002	AMARYL	GLIMEPIRIDE	2MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1995-11-30
N020496-003	AMARYL	GLIMEPIRIDE	4MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1995-11-30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2026-09-14 22:38:34	2026-08	N020496-001	AMARYL	1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1995-11-30	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N020496-002	AMARYL	2MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1995-11-30	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N020496-003	AMARYL	4MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1995-11-30	`84e616aacf4f…`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 4 of 4 · 71 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Glimepiride	GLIMEPIRIDE	A-S Medication Solutions	e8da2484-43a7-4dcb-84d5-d84596feb9f6	2023-08-31	Warnings, Adverse reactions	Name fallback generic name: GLIMEPIRIDE
Glimepiride	GLIMEPIRIDE	A-S Medication Solutions	def20e38-01f7-4ead-beb6-3dc11062a342	2023-06-22	Warnings, Adverse reactions	Name fallback generic name: GLIMEPIRIDE
Glimepiride	GLIMEPIRIDE	Proficient Rx LP	8f687fa6-54eb-4556-8ea6-aafec49a87d1	2023-03-01	Warnings, Adverse reactions	Name fallback generic name: GLIMEPIRIDE
Glimepiride	GLIMEPIRIDE	Proficient Rx LP	beb0cefb-807b-4cc3-ada2-7a8ed4aa8f2b	2022-10-01	Warnings, Adverse reactions	Name fallback generic name: GLIMEPIRIDE
Glimepiride	GLIMEPIRIDE	Proficient Rx LP	5a5747ea-cded-49ed-8807-dd3e2a1159e0	2022-10-01	Warnings, Adverse reactions	Name fallback generic name: GLIMEPIRIDE
Glimepiride	GLIMEPIRIDE	Proficient Rx LP	68cb4fcd-5bc3-4f53-9085-86df6a4246d6	2022-04-01	Warnings, Adverse reactions	Name fallback generic name: GLIMEPIRIDE
Glimepiride	GLIMEPIRIDE	Solco Healthcare U.S., LLC	86acdd9e-8637-43e4-8bf7-b3a123b871b8	2021-08-13	Warnings, Adverse reactions	Name fallback generic name: GLIMEPIRIDE
Glimepiride	GLIMEPIRIDE	Bryant Ranch Prepack	ebb9f080-b11d-5d18-36f0-627107e7fbcd	2020-08-27	Warnings, Adverse reactions	Name fallback generic name: GLIMEPIRIDE
Glimepiride	GLIMEPIRIDE	NCS HealthCare of KY, Inc dba Vangard Labs	669a67c2-2f97-4b7e-8bba-83a015e0fa94	2020-04-30	Warnings, Adverse reactions	Name fallback generic name: GLIMEPIRIDE
Glimepiride	GLIMEPIRIDE	Aphena Pharma Solutions - Tennessee, LLC	00b9e312-921e-41e6-ad27-0a6ce87f8298	2019-02-13	Warnings, Adverse reactions	Name fallback generic name: GLIMEPIRIDE
Glimepiride	GLIMEPIRIDE	Dr. Reddy's Laboratories Limited	07ad4366-4b21-f633-49f3-c2b35f88168d	2019-01-16	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