Application 074591

Type: ANDA
Sponsor: DAVA PHARMS INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	GLYBURIDE (MICRONIZED)	GLYBURIDE	TABLET;ORAL	1.5MG	No	No
002	GLYBURIDE (MICRONIZED)	GLYBURIDE	TABLET;ORAL	3MG	No	No
003	GLYBURIDE (MICRONIZED)	GLYBURIDE	TABLET;ORAL	4.5MG	No	No
004	GLYBURIDE (MICRONIZED)	GLYBURIDE	TABLET;ORAL	6MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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	Approval date
A074591-001	GLYBURIDE (MICRONIZED)	GLYBURIDE	1.5MG	TABLET / ORAL	1997-12-22
A074591-002	GLYBURIDE (MICRONIZED)	GLYBURIDE	3MG	TABLET / ORAL	1997-12-22
A074591-003	GLYBURIDE (MICRONIZED)	GLYBURIDE	4.5MG	TABLET / ORAL	1997-12-22
A074591-004	GLYBURIDE (MICRONIZED)	GLYBURIDE	6MG	TABLET / ORAL	1997-12-22

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 · 164 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A074591-001	GLYBURIDE (MICRONIZED)	1.5MG	TABLET / ORAL	1997-12-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A074591-002	GLYBURIDE (MICRONIZED)	3MG	TABLET / ORAL	1997-12-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A074591-003	GLYBURIDE (MICRONIZED)	4.5MG	TABLET / ORAL	1997-12-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A074591-004	GLYBURIDE (MICRONIZED)	6MG	TABLET / ORAL	1997-12-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074591-001	GLYBURIDE (MICRONIZED)	1.5MG	TABLET / ORAL	1997-12-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074591-002	GLYBURIDE (MICRONIZED)	3MG	TABLET / ORAL	1997-12-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074591-003	GLYBURIDE (MICRONIZED)	4.5MG	TABLET / ORAL	1997-12-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074591-004	GLYBURIDE (MICRONIZED)	6MG	TABLET / ORAL	1997-12-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A074591-001	GLYBURIDE (MICRONIZED)	1.5MG	TABLET / ORAL	1997-12-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A074591-002	GLYBURIDE (MICRONIZED)	3MG	TABLET / ORAL	1997-12-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A074591-003	GLYBURIDE (MICRONIZED)	4.5MG	TABLET / ORAL	1997-12-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A074591-004	GLYBURIDE (MICRONIZED)	6MG	TABLET / ORAL	1997-12-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074591-001	GLYBURIDE (MICRONIZED)	1.5MG	TABLET / ORAL	1997-12-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074591-002	GLYBURIDE (MICRONIZED)	3MG	TABLET / ORAL	1997-12-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074591-003	GLYBURIDE (MICRONIZED)	4.5MG	TABLET / ORAL	1997-12-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074591-004	GLYBURIDE (MICRONIZED)	6MG	TABLET / ORAL	1997-12-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074591-001	GLYBURIDE (MICRONIZED)	1.5MG	TABLET / ORAL	1997-12-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074591-002	GLYBURIDE (MICRONIZED)	3MG	TABLET / ORAL	1997-12-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074591-003	GLYBURIDE (MICRONIZED)	4.5MG	TABLET / ORAL	1997-12-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074591-004	GLYBURIDE (MICRONIZED)	6MG	TABLET / ORAL	1997-12-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074591-001	GLYBURIDE (MICRONIZED)	1.5MG	TABLET / ORAL	1997-12-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074591-002	GLYBURIDE (MICRONIZED)	3MG	TABLET / ORAL	1997-12-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074591-003	GLYBURIDE (MICRONIZED)	4.5MG	TABLET / ORAL	1997-12-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074591-004	GLYBURIDE (MICRONIZED)	6MG	TABLET / ORAL	1997-12-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074591-001	GLYBURIDE (MICRONIZED)	1.5MG	TABLET / ORAL	1997-12-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074591-002	GLYBURIDE (MICRONIZED)	3MG	TABLET / ORAL	1997-12-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074591-003	GLYBURIDE (MICRONIZED)	4.5MG	TABLET / ORAL	1997-12-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074591-004	GLYBURIDE (MICRONIZED)	6MG	TABLET / ORAL	1997-12-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074591-001	GLYBURIDE (MICRONIZED)	1.5MG	TABLET / ORAL	1997-12-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074591-002	GLYBURIDE (MICRONIZED)	3MG	TABLET / ORAL	1997-12-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074591-003	GLYBURIDE (MICRONIZED)	4.5MG	TABLET / ORAL	1997-12-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074591-004	GLYBURIDE (MICRONIZED)	6MG	TABLET / ORAL	1997-12-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074591-001	GLYBURIDE (MICRONIZED)	1.5MG	TABLET / ORAL	1997-12-22	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074591-002	GLYBURIDE (MICRONIZED)	3MG	TABLET / ORAL	1997-12-22	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074591-003	GLYBURIDE (MICRONIZED)	4.5MG	TABLET / ORAL	1997-12-22	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074591-004	GLYBURIDE (MICRONIZED)	6MG	TABLET / ORAL	1997-12-22	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A074591-001	GLYBURIDE (MICRONIZED)	1.5MG	TABLET / ORAL	1997-12-22	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A074591-002	GLYBURIDE (MICRONIZED)	3MG	TABLET / ORAL	1997-12-22	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A074591-003	GLYBURIDE (MICRONIZED)	4.5MG	TABLET / ORAL	1997-12-22	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A074591-004	GLYBURIDE (MICRONIZED)	6MG	TABLET / ORAL	1997-12-22	`d06236e962d9…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A074591-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A074591-002	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A074591-003	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A074591-004	AB	1	`74a2ff9319b5…`
2020-11-12 02:37 UTC	2020-11	A074591-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A074591-002	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A074591-003	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A074591-004	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A074591-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A074591-002	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A074591-003	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A074591-004	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A074591-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A074591-002	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A074591-003	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A074591-004	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A074591-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A074591-002	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A074591-003	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A074591-004	AB	1	`ea99ee380514…`

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 · 38 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	Nivagen Pharmaceuticals, Inc.	43c6f68b-5747-47c6-9538-51ef8c611db4	2021-01-13	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

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
67253-460	GlyBURIDE	GlyBURIDE	Par Pharmaceutical	ANDA	Current
67253-461	GlyBURIDE	GlyBURIDE	Par Pharmaceutical	ANDA	Current
67253-462	GlyBURIDE	GlyBURIDE	Par Pharmaceutical	ANDA	Current