Application 076875

Type: ANDA
Sponsor: RANBAXY LABS LTD

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	GLIMEPIRIDE	GLIMEPIRIDE	TABLET;ORAL	1MG	No	No
002	GLIMEPIRIDE	GLIMEPIRIDE	TABLET;ORAL	2MG	No	No
003	GLIMEPIRIDE	GLIMEPIRIDE	TABLET;ORAL	4MG	No	No
004	GLIMEPIRIDE	GLIMEPIRIDE	TABLET;ORAL	8MG	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
A076875-001	GLIMEPIRIDE	GLIMEPIRIDE	1MG	TABLET / ORAL	2005-10-06
A076875-002	GLIMEPIRIDE	GLIMEPIRIDE	2MG	TABLET / ORAL	2005-10-06
A076875-003	GLIMEPIRIDE	GLIMEPIRIDE	4MG	TABLET / ORAL	2005-10-06
A076875-004	GLIMEPIRIDE	GLIMEPIRIDE	8MG	TABLET / ORAL	2005-10-06

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	A076875-001	GLIMEPIRIDE	1MG	TABLET / ORAL	2005-10-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076875-002	GLIMEPIRIDE	2MG	TABLET / ORAL	2005-10-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076875-003	GLIMEPIRIDE	4MG	TABLET / ORAL	2005-10-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076875-004	GLIMEPIRIDE	8MG	TABLET / ORAL	2005-10-06	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076875-001	GLIMEPIRIDE	1MG	TABLET / ORAL	2005-10-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076875-002	GLIMEPIRIDE	2MG	TABLET / ORAL	2005-10-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076875-003	GLIMEPIRIDE	4MG	TABLET / ORAL	2005-10-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076875-004	GLIMEPIRIDE	8MG	TABLET / ORAL	2005-10-06	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076875-001	GLIMEPIRIDE	1MG	TABLET / ORAL	2005-10-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076875-002	GLIMEPIRIDE	2MG	TABLET / ORAL	2005-10-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076875-003	GLIMEPIRIDE	4MG	TABLET / ORAL	2005-10-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076875-004	GLIMEPIRIDE	8MG	TABLET / ORAL	2005-10-06	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076875-001	GLIMEPIRIDE	1MG	TABLET / ORAL	2005-10-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076875-002	GLIMEPIRIDE	2MG	TABLET / ORAL	2005-10-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076875-003	GLIMEPIRIDE	4MG	TABLET / ORAL	2005-10-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076875-004	GLIMEPIRIDE	8MG	TABLET / ORAL	2005-10-06	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076875-001	GLIMEPIRIDE	1MG	TABLET / ORAL	2005-10-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076875-002	GLIMEPIRIDE	2MG	TABLET / ORAL	2005-10-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076875-003	GLIMEPIRIDE	4MG	TABLET / ORAL	2005-10-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076875-004	GLIMEPIRIDE	8MG	TABLET / ORAL	2005-10-06	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076875-001	GLIMEPIRIDE	1MG	TABLET / ORAL	2005-10-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076875-002	GLIMEPIRIDE	2MG	TABLET / ORAL	2005-10-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076875-003	GLIMEPIRIDE	4MG	TABLET / ORAL	2005-10-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076875-004	GLIMEPIRIDE	8MG	TABLET / ORAL	2005-10-06	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076875-001	GLIMEPIRIDE	1MG	TABLET / ORAL	2005-10-06	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076875-002	GLIMEPIRIDE	2MG	TABLET / ORAL	2005-10-06	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076875-003	GLIMEPIRIDE	4MG	TABLET / ORAL	2005-10-06	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076875-004	GLIMEPIRIDE	8MG	TABLET / ORAL	2005-10-06	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076875-001	GLIMEPIRIDE	1MG	TABLET / ORAL	2005-10-06	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076875-002	GLIMEPIRIDE	2MG	TABLET / ORAL	2005-10-06	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076875-003	GLIMEPIRIDE	4MG	TABLET / ORAL	2005-10-06	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076875-004	GLIMEPIRIDE	8MG	TABLET / ORAL	2005-10-06	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076875-001	GLIMEPIRIDE	1MG	TABLET / ORAL	2005-10-06	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076875-002	GLIMEPIRIDE	2MG	TABLET / ORAL	2005-10-06	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076875-003	GLIMEPIRIDE	4MG	TABLET / ORAL	2005-10-06	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076875-004	GLIMEPIRIDE	8MG	TABLET / ORAL	2005-10-06	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076875-001	GLIMEPIRIDE	1MG	TABLET / ORAL	2005-10-06	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076875-002	GLIMEPIRIDE	2MG	TABLET / ORAL	2005-10-06	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076875-003	GLIMEPIRIDE	4MG	TABLET / ORAL	2005-10-06	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076875-004	GLIMEPIRIDE	8MG	TABLET / ORAL	2005-10-06	`d06236e962d9…`

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 4 · 73 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Glimepiride	GLIMEPIRIDE	St. Mary's Medical Park Pharmacy	fc9d8495-184c-3af1-e053-6394a90a5e29	2026-06-22	Warnings, Adverse reactions	Name fallback brand name: Glimepiride generic name: GLIMEPIRIDE
Glimepiride	GLIMEPIRIDE	Bryant Ranch Prepack	9e863f84-d6f2-4d61-8250-774569e84353	2026-05-19	Warnings, Adverse reactions	Name fallback brand name: Glimepiride generic name: GLIMEPIRIDE
Glimepiride	GLIMEPIRIDE	Cardinal Health 107, LLC	cc2bc07f-3fab-4df1-85cc-dc0c8e60b4fa	2026-05-08	Warnings, Adverse reactions	Name fallback brand name: Glimepiride generic name: GLIMEPIRIDE
Glimepiride	GLIMEPIRIDE	Preferred Pharmaceuticals Inc.	f69e36b9-4940-4f01-b5ea-59dc66dc1e87	2026-05-06	Warnings, Adverse reactions	Name fallback brand name: Glimepiride generic name: GLIMEPIRIDE
Glimepiride	GLIMEPIRIDE	Preferred Pharmaceuticals Inc.	744a5cca-7863-491a-b43a-1b649791702c	2026-05-06	Warnings, Adverse reactions	Name fallback brand name: Glimepiride generic name: GLIMEPIRIDE
Glimepiride	GLIMEPIRIDE	Bryant Ranch Prepack	248c3cb3-4501-4b85-bd1d-0624b6afda2c	2026-04-13	Warnings, Adverse reactions	Name fallback brand name: Glimepiride generic name: GLIMEPIRIDE
Glimepiride	GLIMEPIRIDE	Bryant Ranch Prepack	90d675cb-6def-49a3-b8b4-229f19d6b617	2026-04-13	Warnings, Adverse reactions	Name fallback brand name: Glimepiride generic name: GLIMEPIRIDE
Glimepiride	GLIMEPIRIDE	PD-Rx Pharmaceuticals, Inc.	647a146c-c752-4589-8619-aed5c720ca54	2026-03-19	Warnings, Adverse reactions	Name fallback brand name: Glimepiride generic name: GLIMEPIRIDE
Glimepiride	GLIMEPIRIDE	PD-Rx Pharmaceuticals, Inc.	ed7a3a8e-97dd-4a5a-9497-001acfd2f1f0	2026-03-19	Warnings, Adverse reactions	Name fallback brand name: Glimepiride generic name: GLIMEPIRIDE
Glimepiride	GLIMEPIRIDE	Aurobindo Pharma Limited	28eefc95-d92e-4555-b6c5-2933860b0610	2026-03-18	Warnings, Adverse reactions	Name fallback brand name: Glimepiride generic name: GLIMEPIRIDE
Glimepiride	GLIMEPIRIDE	Bryant Ranch Prepack	62780d2e-083d-4bcb-99ff-1b1b4ade60d9	2026-03-09	Warnings, Adverse reactions	Name fallback brand name: Glimepiride generic name: GLIMEPIRIDE
Glimepiride	GLIMEPIRIDE	PD-Rx Pharmaceuticals, Inc.	1450f455-a14a-4f9b-b3aa-dae49ea0c186	2026-02-26	Warnings, Adverse reactions	Name fallback brand name: Glimepiride generic name: GLIMEPIRIDE
Glimepiride	GLIMEPIRIDE	NuCare Pharmaceuticals,Inc.	bf8e5993-5ee7-d26d-e053-2a95a90ae5df	2026-02-19	Warnings, Adverse reactions	Name fallback brand name: Glimepiride generic name: GLIMEPIRIDE
Glimepiride	GLIMEPIRIDE	Proficient Rx LP	dbed06f9-7758-4c96-9af0-1ed6103db7df	2026-02-01	Warnings, Adverse reactions	Name fallback brand name: Glimepiride generic name: GLIMEPIRIDE
Glimepiride	GLIMEPIRIDE	Proficient Rx LP	e12ab052-e3d6-4246-b727-f1e3f9057f09	2026-02-01	Warnings, Adverse reactions	Name fallback brand name: Glimepiride generic name: GLIMEPIRIDE
Glimepiride	GLIMEPIRIDE	Coupler LLC	41bf4a72-9288-50a1-e063-6394a90a5e7c	2026-01-19	Warnings, Adverse reactions	Name fallback brand name: Glimepiride generic name: GLIMEPIRIDE
Glimepiride	GLIMEPIRIDE	Rising Pharma Holdings, Inc.	48ada723-8144-497d-afd6-a8c52a1dd3ff	2026-01-19	Warnings, Adverse reactions	Name fallback brand name: Glimepiride generic name: GLIMEPIRIDE
Glimepiride	GLIMEPIRIDE	AvPAK	93f1e064-fcbd-e8fd-e053-2995a90a5dbb	2026-01-14	Warnings, Adverse reactions	Name fallback brand name: Glimepiride generic name: GLIMEPIRIDE
Glimepiride	GLIMEPIRIDE	PD-Rx Pharmaceuticals, Inc.	58c4261e-e98f-4280-9562-2800956dff14	2026-01-07	Warnings, Adverse reactions	Name fallback brand name: Glimepiride generic name: GLIMEPIRIDE
Glimepiride	GLIMEPIRIDE	PD-Rx Pharmaceuticals, Inc.	1b3c7d74-f80b-4fb1-8dca-66880af5d3fc	2026-01-07	Warnings, Adverse reactions	Name fallback brand name: Glimepiride generic name: GLIMEPIRIDE

Documents#

Document, Submission type, Date table
Document	Submission type	Date
8975	ORIG	2005-10-11