Application 203379

Type: ANDA
Sponsor: CADILA PHARMS LTD

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	GLYBURIDE	GLYBURIDE	TABLET;ORAL	1.25MG	No	No
002	GLYBURIDE	GLYBURIDE	TABLET;ORAL	2.5MG	No	No
003	GLYBURIDE	GLYBURIDE	TABLET;ORAL	5MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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	TE codes	Approval date
A203379-001	GLYBURIDE	GLYBURIDE	1.25MG	TABLET / ORAL	AB1	2019-01-04
A203379-002	GLYBURIDE	GLYBURIDE	2.5MG	TABLET / ORAL	AB1	2019-01-04
A203379-003	GLYBURIDE	GLYBURIDE	5MG	TABLET / ORAL	AB1	2019-01-04

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A203379-001	AB1
A203379-002	AB1
A203379-003	AB1

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 · 126 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A203379-001	GLYBURIDE	1.25MG	TABLET / ORAL	AB1	2019-01-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203379-002	GLYBURIDE	2.5MG	TABLET / ORAL	AB1	2019-01-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203379-003	GLYBURIDE	5MG	TABLET / ORAL	AB1	2019-01-04	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A203379-001	GLYBURIDE	1.25MG	TABLET / ORAL	AB1	2019-01-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203379-002	GLYBURIDE	2.5MG	TABLET / ORAL	AB1	2019-01-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203379-003	GLYBURIDE	5MG	TABLET / ORAL	AB1	2019-01-04	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203379-001	GLYBURIDE	1.25MG	TABLET / ORAL	AB1	2019-01-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203379-002	GLYBURIDE	2.5MG	TABLET / ORAL	AB1	2019-01-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203379-003	GLYBURIDE	5MG	TABLET / ORAL	AB1	2019-01-04	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203379-001	GLYBURIDE	1.25MG	TABLET / ORAL	AB1	2019-01-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203379-002	GLYBURIDE	2.5MG	TABLET / ORAL	AB1	2019-01-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203379-003	GLYBURIDE	5MG	TABLET / ORAL	AB1	2019-01-04	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203379-001	GLYBURIDE	1.25MG	TABLET / ORAL	AB1	2019-01-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203379-002	GLYBURIDE	2.5MG	TABLET / ORAL	AB1	2019-01-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203379-003	GLYBURIDE	5MG	TABLET / ORAL	AB1	2019-01-04	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203379-001	GLYBURIDE	1.25MG	TABLET / ORAL	AB1	2019-01-04	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203379-002	GLYBURIDE	2.5MG	TABLET / ORAL	AB1	2019-01-04	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203379-003	GLYBURIDE	5MG	TABLET / ORAL	AB1	2019-01-04	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203379-001	GLYBURIDE	1.25MG	TABLET / ORAL	AB1	2019-01-04	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203379-002	GLYBURIDE	2.5MG	TABLET / ORAL	AB1	2019-01-04	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203379-003	GLYBURIDE	5MG	TABLET / ORAL	AB1	2019-01-04	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203379-001	GLYBURIDE	1.25MG	TABLET / ORAL	AB1	2019-01-04	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203379-002	GLYBURIDE	2.5MG	TABLET / ORAL	AB1	2019-01-04	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203379-003	GLYBURIDE	5MG	TABLET / ORAL	AB1	2019-01-04	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203379-001	GLYBURIDE	1.25MG	TABLET / ORAL	AB1	2019-01-04	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203379-002	GLYBURIDE	2.5MG	TABLET / ORAL	AB1	2019-01-04	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203379-003	GLYBURIDE	5MG	TABLET / ORAL	AB1	2019-01-04	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203379-001	GLYBURIDE	1.25MG	TABLET / ORAL	AB1	2019-01-04	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203379-002	GLYBURIDE	2.5MG	TABLET / ORAL	AB1	2019-01-04	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203379-003	GLYBURIDE	5MG	TABLET / ORAL	AB1	2019-01-04	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203379-001	GLYBURIDE	1.25MG	TABLET / ORAL	AB1	2019-01-04	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203379-002	GLYBURIDE	2.5MG	TABLET / ORAL	AB1	2019-01-04	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203379-003	GLYBURIDE	5MG	TABLET / ORAL	AB1	2019-01-04	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203379-001	GLYBURIDE	1.25MG	TABLET / ORAL	AB1	2019-01-04	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203379-002	GLYBURIDE	2.5MG	TABLET / ORAL	AB1	2019-01-04	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203379-003	GLYBURIDE	5MG	TABLET / ORAL	AB1	2019-01-04	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203379-001	GLYBURIDE	1.25MG	TABLET / ORAL	AB1	2019-01-04	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203379-002	GLYBURIDE	2.5MG	TABLET / ORAL	AB1	2019-01-04	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203379-003	GLYBURIDE	5MG	TABLET / ORAL	AB1	2019-01-04	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203379-001	GLYBURIDE	1.25MG	TABLET / ORAL	AB1	2019-01-04	`1e350fbaab3a…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 126 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A203379-001	AB1	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203379-002	AB1	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203379-003	AB1	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A203379-001	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203379-002	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203379-003	AB1	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203379-001	AB1	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203379-002	AB1	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203379-003	AB1	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203379-001	AB1	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203379-002	AB1	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203379-003	AB1	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203379-001	AB1	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203379-002	AB1	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203379-003	AB1	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203379-001	AB1	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203379-002	AB1	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203379-003	AB1	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203379-001	AB1	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203379-002	AB1	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203379-003	AB1	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203379-001	AB1	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203379-002	AB1	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203379-003	AB1	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203379-001	AB1	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203379-002	AB1	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203379-003	AB1	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203379-001	AB1	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203379-002	AB1	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203379-003	AB1	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203379-001	AB1	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203379-002	AB1	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203379-003	AB1	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203379-001	AB1	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203379-002	AB1	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203379-003	AB1	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203379-001	AB1	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203379-002	AB1	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203379-003	AB1	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203379-001	AB1	1	`1e350fbaab3a…`

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 · 11 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Glyburide	GLYBURIDE	REMEDYREPACK INC.	524eec41-37ee-419a-b7a1-d23e888ae6ab	2026-06-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203379 application number: ANDA203379
Glyburide	GLYBURIDE	REMEDYREPACK INC.	e23b9a3b-0184-4d1c-8e2c-668697a6da87	2026-05-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203379 application number: ANDA203379 ndc (product): 70518-3504
Glyburide	GLYBURIDE	Preferred Pharmaceuticals Inc.	cf21c8c0-7247-4d5b-97f8-ae4016144642	2026-05-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203379 application number: ANDA203379
Glyburide	GLYBURIDE	A-S Medication Solutions	51cf08e2-8a2f-4bde-996f-f431f1a68abd	2026-01-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203379 application number: ANDA203379
Glyburide	GLYBURIDE	NuCare Pharmaceuticals,Inc.	ffd31d06-6011-34e2-e053-6394a90a437f	2026-01-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203379 application number: ANDA203379
Glyburide	GLYBURIDE	Bryant Ranch Prepack	db074991-1267-454a-8b1d-b6f52e2132cc	2025-10-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203379 application number: ANDA203379
Glyburide	GLYBURIDE	A-S Medication Solutions	676c0e45-0aa2-4060-ad18-67abb9873a50	2024-10-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203379 application number: ANDA203379
Glyburide	GLYBURIDE	A-S Medication Solutions	d090f978-b1a5-4db7-951d-3f32dd06966c	2024-01-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203379 application number: ANDA203379 ndc (product): 50090-6196
Glyburide	GLYBURIDE	Cadila Pharmaceuticals Limited	ea7a055b-64f0-46bf-aa8e-4a2ef5c3c035	2022-12-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203379 application number: ANDA203379 ndc (product): 71209-011 ndc (product): 71209-009 ndc (product): 71209-010
Glyburide	GLYBURIDE	Modavar Pharmaceuticals LLC	a5de0ef6-4c8b-40ab-b0ed-2003a8086750	2022-12-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203379 application number: ANDA203379 ndc (product): 72241-038 ndc (product): 72241-039 ndc (product): 72241-040
GLYBURIDE	GLYBURIDE	Nivagen Pharmaceuticals, Inc.	43c6f68b-5747-47c6-9538-51ef8c611db4	2021-01-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203379 application number: ANDA203379 ndc (product): 75834-203 ndc (product): 75834-204 ndc (product): 75834-202

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 32 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
50090-6196	Glyburide	Glyburide	A-S Medication Solutions	ANDA	Current
50090-6196	Glyburide	Glyburide	A-S Medication Solutions	ANDA	Current
70518-2644	GLYBURIDE	GLYBURIDE	REMEDYREPACK INC.	ANDA	Current
70518-2644	GLYBURIDE	GLYBURIDE	REMEDYREPACK INC.	ANDA	Current
70518-2644	GLYBURIDE	GLYBURIDE	REMEDYREPACK INC.	ANDA	Current
70518-3504	Glyburide	Glyburide	REMEDYREPACK INC.	ANDA	Current
70518-3504	Glyburide	Glyburide	REMEDYREPACK INC.	ANDA	Current
70934-569	GLYBURIDE	GLYBURIDE	Denton Pharma, Inc. dba Northwind Pharmaceuticals	ANDA	Current
71209-009	Glyburide	Glyburide	Cadila Pharmaceuticals Limited	ANDA	Current
71209-009	Glyburide	Glyburide	Cadila Pharmaceuticals Limited	ANDA	Current
71209-009	Glyburide	Glyburide	Cadila Pharmaceuticals Limited	ANDA	Current
71209-009	Glyburide	Glyburide	Cadila Pharmaceuticals Limited	ANDA	Current
71209-010	Glyburide	Glyburide	Cadila Pharmaceuticals Limited	ANDA	Current
71209-010	Glyburide	Glyburide	Cadila Pharmaceuticals Limited	ANDA	Current
71209-010	Glyburide	Glyburide	Cadila Pharmaceuticals Limited	ANDA	Current
71209-010	Glyburide	Glyburide	Cadila Pharmaceuticals Limited	ANDA	Current
71209-011	Glyburide	Glyburide	Cadila Pharmaceuticals Limited	ANDA	Current
71209-011	Glyburide	Glyburide	Cadila Pharmaceuticals Limited	ANDA	Current
71209-011	Glyburide	Glyburide	Cadila Pharmaceuticals Limited	ANDA	Current
71209-011	Glyburide	Glyburide	Cadila Pharmaceuticals Limited	ANDA	Current
72241-038	Glyburide	Glyburide	Modavar Pharmaceuticals LLC	ANDA	Current
72241-038	Glyburide	Glyburide	Modavar Pharmaceuticals LLC	ANDA	Current
72241-039	Glyburide	Glyburide	Modavar Pharmaceuticals LLC	ANDA	Current
72241-039	Glyburide	Glyburide	Modavar Pharmaceuticals LLC	ANDA	Current
72241-040	Glyburide	Glyburide	Modavar Pharmaceuticals LLC	ANDA	Current
72241-040	Glyburide	Glyburide	Modavar Pharmaceuticals LLC	ANDA	Current
75834-202	GLYBURIDE	GLYBURIDE	Nivagen Pharmaceuticals, Inc.	ANDA	Current
75834-202	GLYBURIDE	GLYBURIDE	Nivagen Pharmaceuticals, Inc.	ANDA	Current
75834-203	GLYBURIDE	GLYBURIDE	Nivagen Pharmaceuticals, Inc.	ANDA	Current
75834-203	GLYBURIDE	GLYBURIDE	Nivagen Pharmaceuticals, Inc.	ANDA	Current
75834-204	GLYBURIDE	GLYBURIDE	Nivagen Pharmaceuticals, Inc.	ANDA	Current
75834-204	GLYBURIDE	GLYBURIDE	Nivagen Pharmaceuticals, Inc.	ANDA	Current