Application 076802

Type: ANDA
Sponsor: TEVA

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	Approval date
A076802-001	GLIMEPIRIDE	GLIMEPIRIDE	1MG	TABLET / ORAL	2005-10-06
A076802-002	GLIMEPIRIDE	GLIMEPIRIDE	2MG	TABLET / ORAL	2005-10-06
A076802-003	GLIMEPIRIDE	GLIMEPIRIDE	4MG	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 4 · 123 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	A076802-001	GLIMEPIRIDE	1MG	TABLET / ORAL	2005-10-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076802-002	GLIMEPIRIDE	2MG	TABLET / ORAL	2005-10-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076802-003	GLIMEPIRIDE	4MG	TABLET / ORAL	2005-10-06	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076802-001	GLIMEPIRIDE	1MG	TABLET / ORAL	2005-10-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076802-002	GLIMEPIRIDE	2MG	TABLET / ORAL	2005-10-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076802-003	GLIMEPIRIDE	4MG	TABLET / ORAL	2005-10-06	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076802-001	GLIMEPIRIDE	1MG	TABLET / ORAL	2005-10-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076802-002	GLIMEPIRIDE	2MG	TABLET / ORAL	2005-10-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076802-003	GLIMEPIRIDE	4MG	TABLET / ORAL	2005-10-06	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076802-001	GLIMEPIRIDE	1MG	TABLET / ORAL	2005-10-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076802-002	GLIMEPIRIDE	2MG	TABLET / ORAL	2005-10-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076802-003	GLIMEPIRIDE	4MG	TABLET / ORAL	2005-10-06	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076802-001	GLIMEPIRIDE	1MG	TABLET / ORAL	2005-10-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076802-002	GLIMEPIRIDE	2MG	TABLET / ORAL	2005-10-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076802-003	GLIMEPIRIDE	4MG	TABLET / ORAL	2005-10-06	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076802-001	GLIMEPIRIDE	1MG	TABLET / ORAL	2005-10-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076802-002	GLIMEPIRIDE	2MG	TABLET / ORAL	2005-10-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076802-003	GLIMEPIRIDE	4MG	TABLET / ORAL	2005-10-06	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076802-001	GLIMEPIRIDE	1MG	TABLET / ORAL	2005-10-06	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076802-002	GLIMEPIRIDE	2MG	TABLET / ORAL	2005-10-06	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076802-003	GLIMEPIRIDE	4MG	TABLET / ORAL	2005-10-06	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076802-001	GLIMEPIRIDE	1MG	TABLET / ORAL	2005-10-06	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076802-002	GLIMEPIRIDE	2MG	TABLET / ORAL	2005-10-06	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076802-003	GLIMEPIRIDE	4MG	TABLET / ORAL	2005-10-06	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076802-001	GLIMEPIRIDE	1MG	TABLET / ORAL	2005-10-06	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076802-002	GLIMEPIRIDE	2MG	TABLET / ORAL	2005-10-06	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076802-003	GLIMEPIRIDE	4MG	TABLET / ORAL	2005-10-06	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076802-001	GLIMEPIRIDE	1MG	TABLET / ORAL	2005-10-06	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076802-002	GLIMEPIRIDE	2MG	TABLET / ORAL	2005-10-06	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076802-003	GLIMEPIRIDE	4MG	TABLET / ORAL	2005-10-06	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076802-001	GLIMEPIRIDE	1MG	TABLET / ORAL	2005-10-06	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076802-002	GLIMEPIRIDE	2MG	TABLET / ORAL	2005-10-06	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076802-003	GLIMEPIRIDE	4MG	TABLET / ORAL	2005-10-06	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076802-001	GLIMEPIRIDE	1MG	TABLET / ORAL	2005-10-06	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076802-002	GLIMEPIRIDE	2MG	TABLET / ORAL	2005-10-06	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076802-003	GLIMEPIRIDE	4MG	TABLET / ORAL	2005-10-06	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076802-001	GLIMEPIRIDE	1MG	TABLET / ORAL	2005-10-06	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076802-002	GLIMEPIRIDE	2MG	TABLET / ORAL	2005-10-06	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076802-003	GLIMEPIRIDE	4MG	TABLET / ORAL	2005-10-06	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076802-001	GLIMEPIRIDE	1MG	TABLET / ORAL	2005-10-06	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-09-15 20:21 UTC	2019-09	A076802-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A076802-002	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A076802-003	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076802-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A076802-002	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A076802-003	AB	1	`ea99ee380514…`

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 3 of 4 · 73 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Glimepiride	GLIMEPIRIDE	Direct_Rx	fd26934e-daea-f47b-e053-6394a90a4bc6	2025-01-22	Warnings, Adverse reactions	Name fallback brand name: Glimepiride generic name: GLIMEPIRIDE
Glimepiride	GLIMEPIRIDE	PD-Rx Pharmaceuticals, Inc.	11ae3189-6139-4470-95d5-72abc0f5b0d0	2025-01-08	Warnings, Adverse reactions	Name fallback brand name: Glimepiride generic name: GLIMEPIRIDE
Glimepiride	GLIMEPIRIDE	PD-Rx Pharmaceuticals, Inc.	2794f86b-d521-414b-8154-5dd1e2519653	2025-01-03	Warnings, Adverse reactions	Name fallback brand name: Glimepiride generic name: GLIMEPIRIDE
Glimepiride	GLIMEPIRIDE	Golden State Medical Supply, Inc.	4f83e203-c102-47fa-bb8e-4fc5541e0d6f	2024-12-05	Warnings, Adverse reactions	Name fallback brand name: Glimepiride generic name: GLIMEPIRIDE
Glimepiride	GLIMEPIRIDE	American Health Packaging	0003458f-352a-46fa-9d99-230daa76ae29	2024-11-13	Warnings, Adverse reactions	Name fallback brand name: Glimepiride generic name: GLIMEPIRIDE
Glimepiride	GLIMEPIRIDE	A-S Medication Solutions	0c25c987-856f-448d-903a-e2c94049b0a7	2024-10-25	Warnings, Adverse reactions	Name fallback brand name: Glimepiride generic name: GLIMEPIRIDE
Glimepiride	GLIMEPIRIDE	A-S Medication Solutions	79ee7533-f75d-4c49-b396-b339654f5c44	2024-10-25	Warnings, Adverse reactions	Name fallback brand name: Glimepiride generic name: GLIMEPIRIDE
Glimepiride	GLIMEPIRIDE	Florida Pharmaceutical Products, LLC	8ff0de99-272e-4e68-9caf-69f3f146ac29	2024-10-08	Warnings, Adverse reactions	Name fallback brand name: Glimepiride generic name: GLIMEPIRIDE
Glimepiride	GLIMEPIRIDE	Carlsbad Technology, Inc.	72d88c6d-2f0a-4bf8-aa7f-1e1811794187	2024-10-02	Warnings, Adverse reactions	Name fallback brand name: Glimepiride generic name: GLIMEPIRIDE
Glimepiride	GLIMEPIRIDE	Direct_rx	230949fd-563e-8dbf-e063-6394a90ab9b6	2024-09-26	Warnings, Adverse reactions	Name fallback brand name: Glimepiride generic name: GLIMEPIRIDE
Glimepiride	GLIMEPIRIDE	A-S Medication Solutions	1e5d562e-b3bf-4502-adc8-c89c8818a9bc	2024-09-18	Warnings, Adverse reactions	Name fallback brand name: Glimepiride generic name: GLIMEPIRIDE
Glimepiride	GLIMEPIRIDE	A-S Medication Solutions	01196f54-32c8-41a0-b0ed-7968ca5d2fa2	2024-09-18	Warnings, Adverse reactions	Name fallback brand name: Glimepiride generic name: GLIMEPIRIDE
Glimepiride	GLIMEPIRIDE	Proficient Rx LP	1f102e4c-1954-4f17-8c60-4dad79f25a25	2024-09-01	Warnings, Adverse reactions	Name fallback brand name: Glimepiride generic name: GLIMEPIRIDE
Glimepiride 3 mg	GLIMEPIRIDE	Lifsa Drugs LLC	51157849-7990-4a8b-ae50-eda1baf93cfa	2024-08-20	Warnings, Adverse reactions	Name fallback generic name: GLIMEPIRIDE
Glimepiride	GLIMEPIRIDE	NuCare Pharmaceuticals,Inc.	abc187f1-8645-23e9-e053-2a95a90a64a7	2024-07-17	Warnings, Adverse reactions	Name fallback brand name: Glimepiride generic name: GLIMEPIRIDE
Glimepiride	GLIMEPIRIDE	NuCare Pharmaceuticals,Inc.	1c335fc7-24d0-5526-e063-6394a90a488e	2024-07-01	Warnings, Adverse reactions	Name fallback brand name: Glimepiride generic name: GLIMEPIRIDE
Glimepiride	GLIMEPIRIDE	Bryant Ranch Prepack	0b12d4ab-fa0c-44d5-888c-265dbb661561	2024-06-11	Warnings, Adverse reactions	Name fallback brand name: Glimepiride generic name: GLIMEPIRIDE
Glimepiride	GLIMEPIRIDE	Bryant Ranch Prepack	cdeda274-955b-413d-b2d4-b14d94f7d20c	2024-04-30	Warnings, Adverse reactions	Name fallback brand name: Glimepiride generic name: GLIMEPIRIDE
Glimepiride	GLIMEPIRIDE	A-S Medication Solutions	be772fca-1579-4fba-a4b7-04b970d09e45	2023-12-17	Warnings, Adverse reactions	Name fallback brand name: Glimepiride generic name: GLIMEPIRIDE
Glimepiride	GLIMEPIRIDE	A-S Medication Solutions	0a1eaf23-d5fd-4b3e-96c5-68ff16f0033b	2023-12-14	Warnings, Adverse reactions	Name fallback brand name: Glimepiride generic name: GLIMEPIRIDE

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 9 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0093-7254	Glimepiride	Glimepiride	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-7254	Glimepiride	Glimepiride	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-7255	Glimepiride	Glimepiride	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-7255	Glimepiride	Glimepiride	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-7256	Glimepiride	Glimepiride	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-7256	Glimepiride	Glimepiride	Teva Pharmaceuticals USA, Inc.	ANDA	Current
42708-083	Glimepiride	Glimepiride	QPharma Inc	ANDA	Current
42708-083	Glimepiride	Glimepiride	QPharma Inc	ANDA	Current
66116-432	Glimepiride	Glimepiride	MedVantx, Inc.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
43107	ORIG	2012-01-27
8967	ORIG	2005-10-11