Application 020051

Type: NDA
Sponsor: PHARMACIA AND UPJOHN

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	GLYNASE	GLYBURIDE	TABLET;ORAL	1.5MG	Yes	No
002	GLYNASE	GLYBURIDE	TABLET;ORAL	3MG	Yes	No
003	GLYNASE	GLYBURIDE	TABLET;ORAL	4.5MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No
004	GLYNASE	GLYBURIDE	TABLET;ORAL	6MG	Yes	Yes

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

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS	Approval date
N020051-001	GLYNASE	GLYBURIDE	1.5MG	TABLET / ORAL	RLD	1992-03-04
N020051-002	GLYNASE	GLYBURIDE	3MG	TABLET / ORAL	RLD	1992-03-04
N020051-003	GLYNASE	GLYBURIDE	4.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1993-09-24
N020051-004	GLYNASE	GLYBURIDE	6MG	TABLET / ORAL	RLD	1993-09-24

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 5 · 172 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	N020051-001	GLYNASE	1.5MG	TABLET / ORAL		RLD	1992-03-04	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N020051-002	GLYNASE	3MG	TABLET / ORAL		RLD	1992-03-04	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N020051-003	GLYNASE	4.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1993-09-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N020051-004	GLYNASE	6MG	TABLET / ORAL		RLD	1993-09-24	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N020051-001	GLYNASE	1.5MG	TABLET / ORAL		RLD	1992-03-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020051-002	GLYNASE	3MG	TABLET / ORAL		RLD	1992-03-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020051-003	GLYNASE	4.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1993-09-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020051-004	GLYNASE	6MG	TABLET / ORAL		RLD	1993-09-24	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N020051-001	GLYNASE	1.5MG	TABLET / ORAL		RLD	1992-03-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020051-002	GLYNASE	3MG	TABLET / ORAL		RLD	1992-03-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020051-003	GLYNASE	4.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1993-09-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020051-004	GLYNASE	6MG	TABLET / ORAL		RLD	1993-09-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020051-001	GLYNASE	1.5MG	TABLET / ORAL		RLD	1992-03-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020051-002	GLYNASE	3MG	TABLET / ORAL		RLD	1992-03-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020051-003	GLYNASE	4.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1993-09-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020051-004	GLYNASE	6MG	TABLET / ORAL		RLD	1993-09-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020051-001	GLYNASE	1.5MG	TABLET / ORAL	AB	RLD	1992-03-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020051-002	GLYNASE	3MG	TABLET / ORAL	AB	RLD	1992-03-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020051-003	GLYNASE	4.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1993-09-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020051-004	GLYNASE	6MG	TABLET / ORAL	AB	RLD, RS	1993-09-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020051-001	GLYNASE	1.5MG	TABLET / ORAL	AB	RLD	1992-03-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020051-002	GLYNASE	3MG	TABLET / ORAL	AB	RLD	1992-03-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020051-003	GLYNASE	4.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1993-09-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020051-004	GLYNASE	6MG	TABLET / ORAL	AB	RLD, RS	1993-09-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020051-001	GLYNASE	1.5MG	TABLET / ORAL	AB	RLD	1992-03-04	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020051-002	GLYNASE	3MG	TABLET / ORAL	AB	RLD	1992-03-04	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020051-003	GLYNASE	4.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1993-09-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020051-004	GLYNASE	6MG	TABLET / ORAL	AB	RLD, RS	1993-09-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020051-001	GLYNASE	1.5MG	TABLET / ORAL	AB	RLD	1992-03-04	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020051-002	GLYNASE	3MG	TABLET / ORAL	AB	RLD	1992-03-04	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020051-003	GLYNASE	4.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1993-09-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020051-004	GLYNASE	6MG	TABLET / ORAL	AB	RLD, RS	1993-09-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020051-001	GLYNASE	1.5MG	TABLET / ORAL	AB	RLD	1992-03-04	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020051-002	GLYNASE	3MG	TABLET / ORAL	AB	RLD	1992-03-04	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020051-003	GLYNASE	4.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1993-09-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020051-004	GLYNASE	6MG	TABLET / ORAL	AB	RLD, RS	1993-09-24	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020051-001	GLYNASE	1.5MG	TABLET / ORAL	AB	RLD	1992-03-04	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020051-002	GLYNASE	3MG	TABLET / ORAL	AB	RLD	1992-03-04	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020051-003	GLYNASE	4.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1993-09-24	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020051-004	GLYNASE	6MG	TABLET / ORAL	AB	RLD, RS	1993-09-24	`5bbf6a4d5a75…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 114 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2025-08-23 18:47 UTC	2025-08	N020051-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020051-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020051-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020051-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020051-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020051-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020051-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020051-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020051-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020051-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020051-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020051-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020051-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020051-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020051-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020051-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020051-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020051-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020051-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020051-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020051-004	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020051-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020051-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020051-004	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020051-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020051-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020051-004	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020051-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020051-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020051-004	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020051-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020051-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020051-004	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020051-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N020051-002	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N020051-004	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020051-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020051-002	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020051-004	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020051-001	AB	1	`5d02ea3f76ae…`

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 2 · 37 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
GLYBURIDE	GLYBURIDE	NuCare Pharmaceuticals,Inc.	a12342fb-123c-2951-e053-2a95a90ac596	2024-06-20	Adverse reactions	Name fallback generic name: GLYBURIDE
GLYBURIDE	GLYBURIDE	NuCare Pharmaceuticals,Inc.	a1233548-bbb8-34aa-e053-2a95a90aea53	2024-06-20	Adverse reactions	Name fallback generic name: GLYBURIDE
Glyburide	GLYBURIDE	NuCare Pharmaceuticals,Inc.	901c50d5-31e7-b073-e053-2995a90abfeb	2024-06-19	Adverse reactions	Name fallback generic name: GLYBURIDE
Glyburide	GLYBURIDE	A-S Medication Solutions	d090f978-b1a5-4db7-951d-3f32dd06966c	2024-01-02	Warnings, Adverse reactions	Name fallback generic name: GLYBURIDE
GLYBURIDE	GLYBURIDE	A-S Medication Solutions	7a280f88-26d4-4fe5-a89b-a6f1d90ed3cd	2023-12-03	Adverse reactions	Name fallback generic name: GLYBURIDE
Glyburide	GLYBURIDE	A-S Medication Solutions	922d1080-52c6-41e4-a310-533d8ca18594	2023-08-28	Warnings, Adverse reactions	Name fallback generic name: GLYBURIDE
GLYBURIDE	GLYBURIDE	A-S Medication Solutions	3c91a408-973b-4572-832f-515f61d5be1f	2023-02-04	Adverse reactions	Name fallback generic name: GLYBURIDE
Glyburide	GLYBURIDE	Teva Pharmaceuticals USA, Inc.	e84c0dfc-a4e9-4c89-b6ea-45732eb412f5	2023-01-09	Warnings, Adverse reactions	Name fallback generic name: GLYBURIDE
Glyburide	GLYBURIDE	Cadila Pharmaceuticals Limited	ea7a055b-64f0-46bf-aa8e-4a2ef5c3c035	2022-12-29	Warnings, Adverse reactions	Name fallback generic name: GLYBURIDE
Glyburide	GLYBURIDE	Modavar Pharmaceuticals LLC	a5de0ef6-4c8b-40ab-b0ed-2003a8086750	2022-12-29	Warnings, Adverse reactions	Name fallback generic name: GLYBURIDE
glyburide	GLYBURIDE	Zydus Lifesciences Limited	5d0e406f-285d-4716-8971-82f665345517	2022-11-16	Adverse reactions	Name fallback generic name: GLYBURIDE
glyburide	GLYBURIDE	Zydus Pharmaceuticals (USA) Inc.	87781ea8-62ec-483c-a4dd-8c965ce59485	2022-11-16	Adverse reactions	Name fallback generic name: GLYBURIDE
Glyburide	GLYBURIDE	TEVA Pharmaceuticals USA Inc	50d16f1d-c814-4411-8749-62561321ecce	2021-07-01	Warnings, Adverse reactions	Name fallback generic name: GLYBURIDE
Glyburide	GLYBURIDE	Proficient Rx LP	ec45f0d8-cab8-4822-895b-17bb443a4f98	2019-11-01	Warnings, Adverse reactions	Name fallback generic name: GLYBURIDE
Glyburide	GLYBURIDE	Proficient Rx LP	b292cb9b-7348-4c07-a871-bc091229fdf8	2019-11-01	Adverse reactions	Name fallback generic name: GLYBURIDE
Glyburide	GLYBURIDE	Proficient Rx LP	240c3ac6-9aab-4185-994e-a0254e3aeb61	2019-11-01	Adverse reactions	Name fallback generic name: GLYBURIDE
Glyburide	GLYBURIDE	Teva Pharmaceuticals USA, Inc.	a56f100f-0f42-4188-81ab-04644b824040	2015-05-31	Warnings, Adverse reactions	Name fallback generic name: GLYBURIDE

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 · 3 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0009-0341	Glynase	glyburide	Pharmacia and Upjohn Company LLC	NDA	Current
0009-0352	Glynase	glyburide	Pharmacia and Upjohn Company LLC	NDA	Current
0009-3449	Glynase	glyburide	Pharmacia and Upjohn Company LLC	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
49581	SUPPL	2017-08-29
49524	SUPPL	2017-08-24
34214	SUPPL	2015-05-27
1955	SUPPL	2015-05-26
34213	SUPPL	2013-10-22
21081	SUPPL	2013-10-16
1954	SUPPL	2011-02-09
34212	SUPPL	2011-02-07
1953	SUPPL	2009-11-19
34211	SUPPL	2009-09-17
34210	SUPPL	2008-11-07
1952	SUPPL	2008-11-03
20462	SUPPL	1997-01-10