Application 202759

Type: ANDA
Sponsor: AUROBINDO PHARMA 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

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

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
A202759-001	GLIMEPIRIDE	GLIMEPIRIDE	1MG	TABLET / ORAL	AB	2012-06-29
A202759-002	GLIMEPIRIDE	GLIMEPIRIDE	2MG	TABLET / ORAL	AB	2012-06-29
A202759-003	GLIMEPIRIDE	GLIMEPIRIDE	4MG	TABLET / ORAL	AB	2012-06-29

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A202759-001	AB
A202759-002	AB
A202759-003	AB

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 · 123 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
2026-02-19 14:30 UTC	2026-02	A202759-001	GLIMEPIRIDE	1MG	TABLET / ORAL	AB	2012-06-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202759-002	GLIMEPIRIDE	2MG	TABLET / ORAL	AB	2012-06-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202759-003	GLIMEPIRIDE	4MG	TABLET / ORAL	AB	2012-06-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202759-001	GLIMEPIRIDE	1MG	TABLET / ORAL	AB	2012-06-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202759-002	GLIMEPIRIDE	2MG	TABLET / ORAL	AB	2012-06-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202759-003	GLIMEPIRIDE	4MG	TABLET / ORAL	AB	2012-06-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202759-001	GLIMEPIRIDE	1MG	TABLET / ORAL	AB	2012-06-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202759-002	GLIMEPIRIDE	2MG	TABLET / ORAL	AB	2012-06-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202759-003	GLIMEPIRIDE	4MG	TABLET / ORAL	AB	2012-06-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202759-001	GLIMEPIRIDE	1MG	TABLET / ORAL	AB	2012-06-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202759-002	GLIMEPIRIDE	2MG	TABLET / ORAL	AB	2012-06-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202759-003	GLIMEPIRIDE	4MG	TABLET / ORAL	AB	2012-06-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202759-001	GLIMEPIRIDE	1MG	TABLET / ORAL	AB	2012-06-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202759-002	GLIMEPIRIDE	2MG	TABLET / ORAL	AB	2012-06-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202759-003	GLIMEPIRIDE	4MG	TABLET / ORAL	AB	2012-06-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202759-001	GLIMEPIRIDE	1MG	TABLET / ORAL	AB	2012-06-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202759-002	GLIMEPIRIDE	2MG	TABLET / ORAL	AB	2012-06-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202759-003	GLIMEPIRIDE	4MG	TABLET / ORAL	AB	2012-06-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202759-001	GLIMEPIRIDE	1MG	TABLET / ORAL	AB	2012-06-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202759-002	GLIMEPIRIDE	2MG	TABLET / ORAL	AB	2012-06-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202759-003	GLIMEPIRIDE	4MG	TABLET / ORAL	AB	2012-06-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202759-001	GLIMEPIRIDE	1MG	TABLET / ORAL	AB	2012-06-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202759-002	GLIMEPIRIDE	2MG	TABLET / ORAL	AB	2012-06-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202759-003	GLIMEPIRIDE	4MG	TABLET / ORAL	AB	2012-06-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202759-001	GLIMEPIRIDE	1MG	TABLET / ORAL	AB	2012-06-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202759-002	GLIMEPIRIDE	2MG	TABLET / ORAL	AB	2012-06-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202759-003	GLIMEPIRIDE	4MG	TABLET / ORAL	AB	2012-06-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202759-001	GLIMEPIRIDE	1MG	TABLET / ORAL	AB	2012-06-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202759-002	GLIMEPIRIDE	2MG	TABLET / ORAL	AB	2012-06-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202759-003	GLIMEPIRIDE	4MG	TABLET / ORAL	AB	2012-06-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202759-001	GLIMEPIRIDE	1MG	TABLET / ORAL	AB	2012-06-29	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202759-002	GLIMEPIRIDE	2MG	TABLET / ORAL	AB	2012-06-29	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202759-003	GLIMEPIRIDE	4MG	TABLET / ORAL	AB	2012-06-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202759-001	GLIMEPIRIDE	1MG	TABLET / ORAL	AB	2012-06-29	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202759-002	GLIMEPIRIDE	2MG	TABLET / ORAL	AB	2012-06-29	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202759-003	GLIMEPIRIDE	4MG	TABLET / ORAL	AB	2012-06-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202759-001	GLIMEPIRIDE	1MG	TABLET / ORAL	AB	2012-06-29	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202759-002	GLIMEPIRIDE	2MG	TABLET / ORAL	AB	2012-06-29	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202759-003	GLIMEPIRIDE	4MG	TABLET / ORAL	AB	2012-06-29	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202759-001	GLIMEPIRIDE	1MG	TABLET / ORAL	AB	2012-06-29	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A202759-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202759-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202759-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202759-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202759-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202759-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202759-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202759-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202759-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202759-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202759-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202759-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202759-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202759-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202759-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202759-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202759-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202759-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202759-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202759-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202759-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202759-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202759-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202759-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202759-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202759-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202759-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202759-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202759-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202759-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202759-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202759-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202759-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202759-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202759-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202759-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202759-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202759-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202759-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202759-001	AB	1	`8072bd15b7f6…`

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 · 17 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	Exact identifier application applno (ANDA): 202759 application number: ANDA202759
Glimepiride	GLIMEPIRIDE	Preferred Pharmaceuticals Inc.	744a5cca-7863-491a-b43a-1b649791702c	2026-05-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202759 application number: ANDA202759
Glimepiride	GLIMEPIRIDE	Bryant Ranch Prepack	248c3cb3-4501-4b85-bd1d-0624b6afda2c	2026-04-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202759 application number: ANDA202759
Glimepiride	GLIMEPIRIDE	Bryant Ranch Prepack	90d675cb-6def-49a3-b8b4-229f19d6b617	2026-04-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202759 application number: ANDA202759
Glimepiride	GLIMEPIRIDE	Aurobindo Pharma Limited	28eefc95-d92e-4555-b6c5-2933860b0610	2026-03-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202759 application number: ANDA202759 ndc (product): 65862-579 ndc (product): 65862-580 ndc (product): 65862-581
Glimepiride	GLIMEPIRIDE	PD-Rx Pharmaceuticals, Inc.	1450f455-a14a-4f9b-b3aa-dae49ea0c186	2026-02-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202759 application number: ANDA202759
Glimepiride	GLIMEPIRIDE	Proficient Rx LP	dbed06f9-7758-4c96-9af0-1ed6103db7df	2026-02-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202759 application number: ANDA202759
Glimepiride	GLIMEPIRIDE	Proficient Rx LP	e12ab052-e3d6-4246-b727-f1e3f9057f09	2026-02-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202759 application number: ANDA202759
Glimepiride	GLIMEPIRIDE	Rising Pharma Holdings, Inc.	48ada723-8144-497d-afd6-a8c52a1dd3ff	2026-01-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202759 application number: ANDA202759 ndc (product): 16571-773 ndc (product): 16571-774 ndc (product): 16571-775
Glimepiride	GLIMEPIRIDE	A-S Medication Solutions	b6ce0eea-149d-4aed-a615-0b1c8f3f6a8e	2025-12-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202759 application number: ANDA202759
Glimepiride	GLIMEPIRIDE	Northwind Health Company, LLC	10a36c79-1b24-46b7-e063-6294a90a8dca	2025-12-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202759 application number: ANDA202759
Glimepiride	GLIMEPIRIDE	A-S Medication Solutions	489dc098-0ac7-4f8e-b258-326229539c7c	2025-08-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202759 application number: ANDA202759
Glimepiride	GLIMEPIRIDE	A-S Medication Solutions	be7175ae-ba53-45b8-9554-e4f4ebf56883	2025-08-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202759 application number: ANDA202759
Glimepiride	GLIMEPIRIDE	Direct_Rx	fd26934e-daea-f47b-e053-6394a90a4bc6	2025-01-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202759 application number: ANDA202759
Glimepiride	GLIMEPIRIDE	A-S Medication Solutions	a11680ba-2750-43ab-a1b1-a52ebe3e139f	2023-09-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202759 application number: ANDA202759 ndc (product): 50090-6322
Glimepiride	GLIMEPIRIDE	A-S Medication Solutions	e8da2484-43a7-4dcb-84d5-d84596feb9f6	2023-08-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202759 application number: ANDA202759
Glimepiride	GLIMEPIRIDE	Proficient Rx LP	8f687fa6-54eb-4556-8ea6-aafec49a87d1	2023-03-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202759 application number: ANDA202759

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 16 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
16571-773	Glimepiride	Glimepiride	Rising Pharma Holdings, Inc.	ANDA	Current
16571-774	Glimepiride	Glimepiride	Rising Pharma Holdings, Inc.	ANDA	Current
16571-775	Glimepiride	Glimepiride	Rising Pharma Holdings, Inc.	ANDA	Current
50090-6322	Glimepiride	Glimepiride	A-S Medication Solutions	ANDA	Current
57237-151	Glimepiride	Glimepiride	Citron Pharma LLC	ANDA	Current
57237-152	Glimepiride	Glimepiride	Citron Pharma LLC	ANDA	Current
57237-153	Glimepiride	Glimepiride	Citron Pharma LLC	ANDA	Current
65862-579	Glimepiride	Glimepiride	Aurobindo Pharma Limited	ANDA	Current
65862-579	Glimepiride	Glimepiride	Aurobindo Pharma Limited	ANDA	Current
65862-579	Glimepiride	Glimepiride	Aurobindo Pharma Limited	ANDA	Current
65862-580	Glimepiride	Glimepiride	Aurobindo Pharma Limited	ANDA	Current
65862-580	Glimepiride	Glimepiride	Aurobindo Pharma Limited	ANDA	Current
65862-580	Glimepiride	Glimepiride	Aurobindo Pharma Limited	ANDA	Current
65862-581	Glimepiride	Glimepiride	Aurobindo Pharma Limited	ANDA	Current
65862-581	Glimepiride	Glimepiride	Aurobindo Pharma Limited	ANDA	Current
65862-581	Glimepiride	Glimepiride	Aurobindo Pharma Limited	ANDA	Current