Application 091220

Type: ANDA
Sponsor: MICRO LABS

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	3MG	No	No
004	GLIMEPIRIDE	GLIMEPIRIDE	TABLET;ORAL	4MG	No	No
005	GLIMEPIRIDE	GLIMEPIRIDE	TABLET;ORAL	6MG	No	No
006	GLIMEPIRIDE	GLIMEPIRIDE	TABLET;ORAL	8MG	No	No

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

Orange Book products#

Current product rows page 1 of 1 · 6 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A091220-001	GLIMEPIRIDE	GLIMEPIRIDE	1MG	TABLET / ORAL	AB	2012-06-29
A091220-002	GLIMEPIRIDE	GLIMEPIRIDE	2MG	TABLET / ORAL	AB	2012-06-29
A091220-003	GLIMEPIRIDE	GLIMEPIRIDE	3MG	TABLET / ORAL		2012-06-29
A091220-004	GLIMEPIRIDE	GLIMEPIRIDE	4MG	TABLET / ORAL	AB	2012-06-29
A091220-005	GLIMEPIRIDE	GLIMEPIRIDE	6MG	TABLET / ORAL		2012-06-29
A091220-006	GLIMEPIRIDE	GLIMEPIRIDE	8MG	TABLET / ORAL	AB	2012-06-29

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-product	TE code
A091220-001	AB
A091220-002	AB
A091220-004	AB
A091220-006	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 7 · 252 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	A091220-001	GLIMEPIRIDE	1MG	TABLET / ORAL	AB	2012-06-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A091220-002	GLIMEPIRIDE	2MG	TABLET / ORAL	AB	2012-06-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A091220-003	GLIMEPIRIDE	3MG	TABLET / ORAL		2012-06-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A091220-004	GLIMEPIRIDE	4MG	TABLET / ORAL	AB	2012-06-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A091220-005	GLIMEPIRIDE	6MG	TABLET / ORAL		2012-06-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A091220-006	GLIMEPIRIDE	8MG	TABLET / ORAL	AB	2012-06-29	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A091220-001	GLIMEPIRIDE	1MG	TABLET / ORAL	AB	2012-06-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091220-002	GLIMEPIRIDE	2MG	TABLET / ORAL	AB	2012-06-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091220-003	GLIMEPIRIDE	3MG	TABLET / ORAL		2012-06-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091220-004	GLIMEPIRIDE	4MG	TABLET / ORAL	AB	2012-06-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091220-005	GLIMEPIRIDE	6MG	TABLET / ORAL		2012-06-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091220-006	GLIMEPIRIDE	8MG	TABLET / ORAL	AB	2012-06-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091220-001	GLIMEPIRIDE	1MG	TABLET / ORAL	AB	2012-06-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091220-002	GLIMEPIRIDE	2MG	TABLET / ORAL	AB	2012-06-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091220-003	GLIMEPIRIDE	3MG	TABLET / ORAL		2012-06-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091220-004	GLIMEPIRIDE	4MG	TABLET / ORAL	AB	2012-06-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091220-005	GLIMEPIRIDE	6MG	TABLET / ORAL		2012-06-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091220-006	GLIMEPIRIDE	8MG	TABLET / ORAL	AB	2012-06-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091220-001	GLIMEPIRIDE	1MG	TABLET / ORAL	AB	2012-06-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091220-002	GLIMEPIRIDE	2MG	TABLET / ORAL	AB	2012-06-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091220-003	GLIMEPIRIDE	3MG	TABLET / ORAL		2012-06-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091220-004	GLIMEPIRIDE	4MG	TABLET / ORAL	AB	2012-06-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091220-005	GLIMEPIRIDE	6MG	TABLET / ORAL		2012-06-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091220-006	GLIMEPIRIDE	8MG	TABLET / ORAL	AB	2012-06-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091220-001	GLIMEPIRIDE	1MG	TABLET / ORAL	AB	2012-06-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091220-002	GLIMEPIRIDE	2MG	TABLET / ORAL	AB	2012-06-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091220-003	GLIMEPIRIDE	3MG	TABLET / ORAL		2012-06-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091220-004	GLIMEPIRIDE	4MG	TABLET / ORAL	AB	2012-06-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091220-005	GLIMEPIRIDE	6MG	TABLET / ORAL		2012-06-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091220-006	GLIMEPIRIDE	8MG	TABLET / ORAL	AB	2012-06-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091220-001	GLIMEPIRIDE	1MG	TABLET / ORAL	AB	2012-06-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091220-002	GLIMEPIRIDE	2MG	TABLET / ORAL	AB	2012-06-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091220-003	GLIMEPIRIDE	3MG	TABLET / ORAL		2012-06-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091220-004	GLIMEPIRIDE	4MG	TABLET / ORAL	AB	2012-06-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091220-005	GLIMEPIRIDE	6MG	TABLET / ORAL		2012-06-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091220-006	GLIMEPIRIDE	8MG	TABLET / ORAL	AB	2012-06-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091220-001	GLIMEPIRIDE	1MG	TABLET / ORAL	AB	2012-06-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091220-002	GLIMEPIRIDE	2MG	TABLET / ORAL	AB	2012-06-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091220-003	GLIMEPIRIDE	3MG	TABLET / ORAL		2012-06-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091220-004	GLIMEPIRIDE	4MG	TABLET / ORAL	AB	2012-06-29	`03ed91905a0d…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 168 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	A091220-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A091220-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A091220-004	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A091220-006	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A091220-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091220-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091220-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091220-006	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091220-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091220-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091220-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091220-006	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091220-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091220-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091220-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091220-006	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091220-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091220-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091220-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091220-006	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091220-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091220-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091220-004	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091220-006	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091220-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091220-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091220-004	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091220-006	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091220-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091220-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091220-004	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091220-006	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091220-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091220-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091220-004	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091220-006	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091220-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091220-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091220-004	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091220-006	AB	1	`d8e5a09893c0…`

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 · 6 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Glimepiride	GLIMEPIRIDE	Bryant Ranch Prepack	62780d2e-083d-4bcb-99ff-1b1b4ade60d9	2026-03-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091220 application number: ANDA091220 ndc (product): 71335-1886
Glimepiride	GLIMEPIRIDE	BluePoint Laboratories	a01b0466-13f5-4c47-ae55-c5f1527d9414	2025-07-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091220 application number: ANDA091220
Glimepiride	GLIMEPIRIDE	Bryant Ranch Prepack	d4513181-4558-4d9a-851b-acf7e3eda25a	2025-06-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091220 application number: ANDA091220 ndc (product): 71335-1885
Glimepiride	GLIMEPIRIDE	Micro Labs Limited	60e9397e-83b9-489e-9683-6f87e458bbaa	2025-05-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091220 application number: ANDA091220 ndc (product): 42571-104 ndc (product): 42571-100 ndc (product): 42571-101 ndc (product): 42571-105 ndc (product): 42571-103 ndc (product): 42571-102
Glimepiride 3 mg	GLIMEPIRIDE	Lifsa Drugs LLC	51157849-7990-4a8b-ae50-eda1baf93cfa	2024-08-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091220 application number: ANDA091220
Glimepiride	GLIMEPIRIDE	NCS HealthCare of KY, Inc dba Vangard Labs	669a67c2-2f97-4b7e-8bba-83a015e0fa94	2020-04-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091220 application number: ANDA091220 ndc (product): 0615-8332 ndc (product): 0615-8333 ndc (product): 0615-8334

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 45 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0615-8332	Glimepiride	Glimepiride	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
0615-8333	Glimepiride	Glimepiride	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
0615-8334	Glimepiride	Glimepiride	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
33261-831	Glimepiride	Glimepiride	Aidarex Pharmaceuticals LLC	ANDA	Current
42571-100	Glimepiride	Glimepiride	Micro Labs Limited	ANDA	Current
42571-100	Glimepiride	Glimepiride	Micro Labs Limited	ANDA	Current
42571-100	Glimepiride	Glimepiride	Micro Labs Limited	ANDA	Current
42571-100	Glimepiride	Glimepiride	Micro Labs Limited	ANDA	Current
42571-100	Glimepiride	Glimepiride	Micro Labs Limited	ANDA	Current
42571-101	Glimepiride	Glimepiride	Micro Labs Limited	ANDA	Current
42571-101	Glimepiride	Glimepiride	Micro Labs Limited	ANDA	Current
42571-101	Glimepiride	Glimepiride	Micro Labs Limited	ANDA	Current
42571-101	Glimepiride	Glimepiride	Micro Labs Limited	ANDA	Current
42571-101	Glimepiride	Glimepiride	Micro Labs Limited	ANDA	Current
42571-102	Glimepiride	Glimepiride	Micro Labs Limited	ANDA	Current
42571-102	Glimepiride	Glimepiride	Micro Labs Limited	ANDA	Current
42571-102	Glimepiride	Glimepiride	Micro Labs Limited	ANDA	Current
42571-102	Glimepiride	Glimepiride	Micro Labs Limited	ANDA	Current
42571-102	Glimepiride	Glimepiride	Micro Labs Limited	ANDA	Current
42571-103	Glimepiride	Glimepiride	Micro Labs Limited	ANDA	Current
42571-103	Glimepiride	Glimepiride	Micro Labs Limited	ANDA	Current
42571-103	Glimepiride	Glimepiride	Micro Labs Limited	ANDA	Current
42571-103	Glimepiride	Glimepiride	Micro Labs Limited	ANDA	Current
42571-103	Glimepiride	Glimepiride	Micro Labs Limited	ANDA	Current
42571-104	Glimepiride	Glimepiride	Micro Labs Limited	ANDA	Current
42571-104	Glimepiride	Glimepiride	Micro Labs Limited	ANDA	Current
42571-104	Glimepiride	Glimepiride	Micro Labs Limited	ANDA	Current
42571-104	Glimepiride	Glimepiride	Micro Labs Limited	ANDA	Current
42571-104	Glimepiride	Glimepiride	Micro Labs Limited	ANDA	Current
42571-105	Glimepiride	Glimepiride	Micro Labs Limited	ANDA	Current
42571-105	Glimepiride	Glimepiride	Micro Labs Limited	ANDA	Current
42571-105	Glimepiride	Glimepiride	Micro Labs Limited	ANDA	Current
42571-105	Glimepiride	Glimepiride	Micro Labs Limited	ANDA	Current
42571-105	Glimepiride	Glimepiride	Micro Labs Limited	ANDA	Current
53217-285	Glimepiride	Glimepiride	Aidarex Pharmaceuticals LLC	ANDA	Current
68071-1991	Glimepiride	Glimepiride	NuCare Pharmaceuticals, Inc.	ANDA	Current
68788-6801	Glimepiride	Glimepiride	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-6801	Glimepiride	Glimepiride	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-6818	Glimepiride	Glimepiride	Preferred Pharmaceuticals Inc.	ANDA	Current
69452-128	Glimepiride	Glimepiride	Bionpharma Inc.	ANDA	Current
69452-129	Glimepiride	Glimepiride	Bionpharma Inc.	ANDA	Current
69452-130	Glimepiride	Glimepiride	Bionpharma Inc.	ANDA	Current
71335-1885	Glimepiride	Glimepiride	Bryant Ranch Prepack	ANDA	Current
71335-1885	Glimepiride	Glimepiride	Bryant Ranch Prepack	ANDA	Current
71335-1886	Glimepiride	Glimepiride	Bryant Ranch Prepack	ANDA	Current