Application 202112

Type: ANDA
Sponsor: INDOCO REMEDIES

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
A202112-001	GLIMEPIRIDE	GLIMEPIRIDE	1MG	TABLET / ORAL	AB	2013-04-17
A202112-002	GLIMEPIRIDE	GLIMEPIRIDE	2MG	TABLET / ORAL	AB	2013-04-17
A202112-003	GLIMEPIRIDE	GLIMEPIRIDE	4MG	TABLET / ORAL	AB	2013-04-17

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A202112-001	AB
A202112-002	AB
A202112-003	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	A202112-001	GLIMEPIRIDE	1MG	TABLET / ORAL	AB	2013-04-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202112-002	GLIMEPIRIDE	2MG	TABLET / ORAL	AB	2013-04-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202112-003	GLIMEPIRIDE	4MG	TABLET / ORAL	AB	2013-04-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202112-001	GLIMEPIRIDE	1MG	TABLET / ORAL	AB	2013-04-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202112-002	GLIMEPIRIDE	2MG	TABLET / ORAL	AB	2013-04-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202112-003	GLIMEPIRIDE	4MG	TABLET / ORAL	AB	2013-04-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202112-001	GLIMEPIRIDE	1MG	TABLET / ORAL	AB	2013-04-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202112-002	GLIMEPIRIDE	2MG	TABLET / ORAL	AB	2013-04-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202112-003	GLIMEPIRIDE	4MG	TABLET / ORAL	AB	2013-04-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202112-001	GLIMEPIRIDE	1MG	TABLET / ORAL	AB	2013-04-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202112-002	GLIMEPIRIDE	2MG	TABLET / ORAL	AB	2013-04-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202112-003	GLIMEPIRIDE	4MG	TABLET / ORAL	AB	2013-04-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202112-001	GLIMEPIRIDE	1MG	TABLET / ORAL	AB	2013-04-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202112-002	GLIMEPIRIDE	2MG	TABLET / ORAL	AB	2013-04-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202112-003	GLIMEPIRIDE	4MG	TABLET / ORAL	AB	2013-04-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202112-001	GLIMEPIRIDE	1MG	TABLET / ORAL	AB	2013-04-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202112-002	GLIMEPIRIDE	2MG	TABLET / ORAL	AB	2013-04-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202112-003	GLIMEPIRIDE	4MG	TABLET / ORAL	AB	2013-04-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202112-001	GLIMEPIRIDE	1MG	TABLET / ORAL	AB	2013-04-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202112-002	GLIMEPIRIDE	2MG	TABLET / ORAL	AB	2013-04-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202112-003	GLIMEPIRIDE	4MG	TABLET / ORAL	AB	2013-04-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202112-001	GLIMEPIRIDE	1MG	TABLET / ORAL	AB	2013-04-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202112-002	GLIMEPIRIDE	2MG	TABLET / ORAL	AB	2013-04-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202112-003	GLIMEPIRIDE	4MG	TABLET / ORAL	AB	2013-04-17	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202112-001	GLIMEPIRIDE	1MG	TABLET / ORAL	AB	2013-04-17	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202112-002	GLIMEPIRIDE	2MG	TABLET / ORAL	AB	2013-04-17	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202112-003	GLIMEPIRIDE	4MG	TABLET / ORAL	AB	2013-04-17	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202112-001	GLIMEPIRIDE	1MG	TABLET / ORAL	AB	2013-04-17	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202112-002	GLIMEPIRIDE	2MG	TABLET / ORAL	AB	2013-04-17	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202112-003	GLIMEPIRIDE	4MG	TABLET / ORAL	AB	2013-04-17	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202112-001	GLIMEPIRIDE	1MG	TABLET / ORAL	AB	2013-04-17	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202112-002	GLIMEPIRIDE	2MG	TABLET / ORAL	AB	2013-04-17	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202112-003	GLIMEPIRIDE	4MG	TABLET / ORAL	AB	2013-04-17	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202112-001	GLIMEPIRIDE	1MG	TABLET / ORAL	AB	2013-04-17	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202112-002	GLIMEPIRIDE	2MG	TABLET / ORAL	AB	2013-04-17	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202112-003	GLIMEPIRIDE	4MG	TABLET / ORAL	AB	2013-04-17	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202112-001	GLIMEPIRIDE	1MG	TABLET / ORAL	AB	2013-04-17	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202112-002	GLIMEPIRIDE	2MG	TABLET / ORAL	AB	2013-04-17	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202112-003	GLIMEPIRIDE	4MG	TABLET / ORAL	AB	2013-04-17	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202112-001	GLIMEPIRIDE	1MG	TABLET / ORAL	AB	2013-04-17	`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	A202112-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202112-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202112-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202112-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202112-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202112-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202112-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202112-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202112-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202112-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202112-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202112-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202112-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202112-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202112-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202112-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202112-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202112-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202112-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202112-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202112-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202112-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202112-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202112-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202112-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202112-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202112-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202112-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202112-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202112-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202112-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202112-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202112-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202112-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202112-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202112-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202112-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202112-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202112-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202112-001	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 · 16 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Glimepiride	GLIMEPIRIDE	Preferred Pharmaceuticals Inc.	f69e36b9-4940-4f01-b5ea-59dc66dc1e87	2026-05-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202112 application number: ANDA202112
Glimepiride	GLIMEPIRIDE	Coupler LLC	41bf4a72-9288-50a1-e063-6394a90a5e7c	2026-01-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202112 application number: ANDA202112
Glimepiride	GLIMEPIRIDE	REMEDYREPACK INC.	c994796e-dd3d-4f40-a8f2-d317f55e34d5	2025-11-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202112 application number: ANDA202112
Glimepiride	GLIMEPIRIDE	REMEDYREPACK INC.	95c59026-a2db-4579-b58c-b0a8e12e7f84	2025-09-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202112 application number: ANDA202112
Glimepiride	GLIMEPIRIDE	ST. MARY'S MEDICAL PARK PHARMACY	35ba31ef-2b90-61c6-e063-6394a90a59ee	2025-05-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202112 application number: ANDA202112
Glimepiride	GLIMEPIRIDE	A-S Medication Solutions	49bf2d48-efa8-487b-b861-0124c3a4c951	2025-04-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202112 application number: ANDA202112
Glimepiride	GLIMEPIRIDE	Bryant Ranch Prepack	661b5b13-6334-4965-8dc5-709e19080584	2025-01-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202112 application number: ANDA202112
Glimepiride	GLIMEPIRIDE	A-S Medication Solutions	0c25c987-856f-448d-903a-e2c94049b0a7	2024-10-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202112 application number: ANDA202112
Glimepiride	GLIMEPIRIDE	A-S Medication Solutions	79ee7533-f75d-4c49-b396-b339654f5c44	2024-10-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202112 application number: ANDA202112
Glimepiride	GLIMEPIRIDE	Florida Pharmaceutical Products, LLC	8ff0de99-272e-4e68-9caf-69f3f146ac29	2024-10-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202112 application number: ANDA202112
Glimepiride	GLIMEPIRIDE	Direct_rx	230949fd-563e-8dbf-e063-6394a90ab9b6	2024-09-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202112 application number: ANDA202112
Glimepiride	GLIMEPIRIDE	A-S Medication Solutions	1e5d562e-b3bf-4502-adc8-c89c8818a9bc	2024-09-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202112 application number: ANDA202112
Glimepiride	GLIMEPIRIDE	A-S Medication Solutions	01196f54-32c8-41a0-b0ed-7968ca5d2fa2	2024-09-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202112 application number: ANDA202112
Glimepiride	GLIMEPIRIDE	NuCare Pharmaceuticals,Inc.	1c335fc7-24d0-5526-e063-6394a90a488e	2024-07-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202112 application number: ANDA202112
Glimepiride	GLIMEPIRIDE	Bryant Ranch Prepack	0b12d4ab-fa0c-44d5-888c-265dbb661561	2024-06-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202112 application number: ANDA202112
Glimepiride	GLIMEPIRIDE	Bryant Ranch Prepack	cdeda274-955b-413d-b2d4-b14d94f7d20c	2024-04-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202112 application number: ANDA202112

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 13 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
50090-3172	Glimepiride	Glimepiride	A-S Medication Solutions	ANDA	Current
50090-3172	Glimepiride	Glimepiride	A-S Medication Solutions	ANDA	Current
50090-3189	Glimepiride	Glimepiride	A-S Medication Solutions	ANDA	Current
50090-3189	Glimepiride	Glimepiride	A-S Medication Solutions	ANDA	Current
51655-381	Glimepiride	Glimepiride	Northwind Pharmaceuticals	ANDA	Current
68071-3024	Glimepiride	Glimepiride	NuCare Pharmaceuticals, Inc.	ANDA	Current
68071-3239	Glimepiride	Glimepiride	NuCare Pharmaceuticals, Inc.	ANDA	Current
69543-123	Glimepiride	Glimepiride	Virtus Pharmaceuticals	ANDA	Current
69543-123	Glimepiride	Glimepiride	Virtus Pharmaceuticals	ANDA	Current
69543-124	Glimepiride	Glimepiride	Virtus Pharmaceuticals	ANDA	Current
69543-124	Glimepiride	Glimepiride	Virtus Pharmaceuticals	ANDA	Current
69543-125	Glimepiride	Glimepiride	Virtus Pharmaceuticals	ANDA	Current
69543-125	Glimepiride	Glimepiride	Virtus Pharmaceuticals	ANDA	Current