Application 077270

Type: ANDA
Sponsor: TEVA PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	GLIPIZIDE AND METFORMIN HYDROCHLORIDE	GLIPIZIDE; METFORMIN HYDROCHLORIDE	TABLET;ORAL	2.5MG;250MG	No	No
002	GLIPIZIDE AND METFORMIN HYDROCHLORIDE	GLIPIZIDE; METFORMIN HYDROCHLORIDE	TABLET;ORAL	2.5MG;500MG	No	No
003	GLIPIZIDE AND METFORMIN HYDROCHLORIDE	GLIPIZIDE; METFORMIN HYDROCHLORIDE	TABLET;ORAL	5MG;500MG	No	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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	RLD / RS	Approval date
A077270-001	GLIPIZIDE AND METFORMIN HYDROCHLORIDE	GLIPIZIDE; METFORMIN HYDROCHLORIDE	2.5MG;250MG	TABLET / ORAL	AB		2005-10-28
A077270-002	GLIPIZIDE AND METFORMIN HYDROCHLORIDE	GLIPIZIDE; METFORMIN HYDROCHLORIDE	2.5MG;500MG	TABLET / ORAL	AB		2005-10-28
A077270-003	GLIPIZIDE AND METFORMIN HYDROCHLORIDE	GLIPIZIDE; METFORMIN HYDROCHLORIDE	5MG;500MG	TABLET / ORAL	AB	RS	2005-10-28

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A077270-001	AB
A077270-002	AB
A077270-003	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 · 129 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A077270-001	GLIPIZIDE AND METFORMIN HYDROCHLORIDE	2.5MG;250MG	TABLET / ORAL	AB		2005-10-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077270-002	GLIPIZIDE AND METFORMIN HYDROCHLORIDE	2.5MG;500MG	TABLET / ORAL	AB		2005-10-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077270-003	GLIPIZIDE AND METFORMIN HYDROCHLORIDE	5MG;500MG	TABLET / ORAL	AB	RS	2005-10-28	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A077270-001	GLIPIZIDE AND METFORMIN HYDROCHLORIDE	2.5MG;250MG	TABLET / ORAL	AB		2005-10-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077270-002	GLIPIZIDE AND METFORMIN HYDROCHLORIDE	2.5MG;500MG	TABLET / ORAL	AB		2005-10-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077270-003	GLIPIZIDE AND METFORMIN HYDROCHLORIDE	5MG;500MG	TABLET / ORAL	AB	RS	2005-10-28	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077270-001	GLIPIZIDE AND METFORMIN HYDROCHLORIDE	2.5MG;250MG	TABLET / ORAL	AB		2005-10-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077270-002	GLIPIZIDE AND METFORMIN HYDROCHLORIDE	2.5MG;500MG	TABLET / ORAL	AB		2005-10-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077270-003	GLIPIZIDE AND METFORMIN HYDROCHLORIDE	5MG;500MG	TABLET / ORAL	AB	RS	2005-10-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077270-001	GLIPIZIDE AND METFORMIN HYDROCHLORIDE	2.5MG;250MG	TABLET / ORAL	AB		2005-10-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077270-002	GLIPIZIDE AND METFORMIN HYDROCHLORIDE	2.5MG;500MG	TABLET / ORAL	AB		2005-10-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077270-003	GLIPIZIDE AND METFORMIN HYDROCHLORIDE	5MG;500MG	TABLET / ORAL	AB	RS	2005-10-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077270-001	GLIPIZIDE AND METFORMIN HYDROCHLORIDE	2.5MG;250MG	TABLET / ORAL	AB		2005-10-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077270-002	GLIPIZIDE AND METFORMIN HYDROCHLORIDE	2.5MG;500MG	TABLET / ORAL	AB		2005-10-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077270-003	GLIPIZIDE AND METFORMIN HYDROCHLORIDE	5MG;500MG	TABLET / ORAL	AB	RS	2005-10-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077270-001	GLIPIZIDE AND METFORMIN HYDROCHLORIDE	2.5MG;250MG	TABLET / ORAL	AB		2005-10-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077270-002	GLIPIZIDE AND METFORMIN HYDROCHLORIDE	2.5MG;500MG	TABLET / ORAL	AB		2005-10-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077270-003	GLIPIZIDE AND METFORMIN HYDROCHLORIDE	5MG;500MG	TABLET / ORAL	AB	RS	2005-10-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077270-001	GLIPIZIDE AND METFORMIN HYDROCHLORIDE	2.5MG;250MG	TABLET / ORAL	AB		2005-10-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077270-002	GLIPIZIDE AND METFORMIN HYDROCHLORIDE	2.5MG;500MG	TABLET / ORAL	AB		2005-10-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077270-003	GLIPIZIDE AND METFORMIN HYDROCHLORIDE	5MG;500MG	TABLET / ORAL	AB	RS	2005-10-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077270-001	GLIPIZIDE AND METFORMIN HYDROCHLORIDE	2.5MG;250MG	TABLET / ORAL	AB		2005-10-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077270-002	GLIPIZIDE AND METFORMIN HYDROCHLORIDE	2.5MG;500MG	TABLET / ORAL	AB		2005-10-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077270-003	GLIPIZIDE AND METFORMIN HYDROCHLORIDE	5MG;500MG	TABLET / ORAL	AB	RS	2005-10-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077270-001	GLIPIZIDE AND METFORMIN HYDROCHLORIDE	2.5MG;250MG	TABLET / ORAL	AB		2005-10-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077270-002	GLIPIZIDE AND METFORMIN HYDROCHLORIDE	2.5MG;500MG	TABLET / ORAL	AB		2005-10-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077270-003	GLIPIZIDE AND METFORMIN HYDROCHLORIDE	5MG;500MG	TABLET / ORAL	AB	RS	2005-10-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077270-001	GLIPIZIDE AND METFORMIN HYDROCHLORIDE	2.5MG;250MG	TABLET / ORAL	AB		2005-10-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077270-002	GLIPIZIDE AND METFORMIN HYDROCHLORIDE	2.5MG;500MG	TABLET / ORAL	AB		2005-10-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077270-003	GLIPIZIDE AND METFORMIN HYDROCHLORIDE	5MG;500MG	TABLET / ORAL	AB	RS	2005-10-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077270-001	GLIPIZIDE AND METFORMIN HYDROCHLORIDE	2.5MG;250MG	TABLET / ORAL	AB		2005-10-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077270-002	GLIPIZIDE AND METFORMIN HYDROCHLORIDE	2.5MG;500MG	TABLET / ORAL	AB		2005-10-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077270-003	GLIPIZIDE AND METFORMIN HYDROCHLORIDE	5MG;500MG	TABLET / ORAL	AB	RS	2005-10-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077270-001	GLIPIZIDE AND METFORMIN HYDROCHLORIDE	2.5MG;250MG	TABLET / ORAL	AB		2005-10-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077270-002	GLIPIZIDE AND METFORMIN HYDROCHLORIDE	2.5MG;500MG	TABLET / ORAL	AB		2005-10-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077270-003	GLIPIZIDE AND METFORMIN HYDROCHLORIDE	5MG;500MG	TABLET / ORAL	AB	RS	2005-10-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077270-001	GLIPIZIDE AND METFORMIN HYDROCHLORIDE	2.5MG;250MG	TABLET / ORAL	AB		2005-10-28	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077270-002	GLIPIZIDE AND METFORMIN HYDROCHLORIDE	2.5MG;500MG	TABLET / ORAL	AB		2005-10-28	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077270-003	GLIPIZIDE AND METFORMIN HYDROCHLORIDE	5MG;500MG	TABLET / ORAL	AB	RS	2005-10-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077270-001	GLIPIZIDE AND METFORMIN HYDROCHLORIDE	2.5MG;250MG	TABLET / ORAL	AB		2005-10-28	`301d65b070ca…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 129 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A077270-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077270-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077270-003	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A077270-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077270-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077270-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077270-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077270-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077270-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077270-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077270-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077270-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077270-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077270-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077270-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077270-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077270-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077270-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077270-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077270-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077270-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077270-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077270-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077270-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077270-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077270-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077270-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077270-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077270-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077270-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077270-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077270-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077270-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077270-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077270-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077270-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077270-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077270-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077270-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077270-001	AB	1	`301d65b070ca…`

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Glipizide and Metformin Hydrochloride	GLIPIZIDE AND METFORMIN HYDROCHLORIDE	Teva Pharmaceuticals USA, Inc.	03d9ce02-0559-494c-a53d-de9b9a64b606	2026-06-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077270 application number: ANDA077270 ndc (product): 0093-7457 ndc (product): 0093-7455 ndc (product): 0093-7456
Glipizide and Metformin Hydrochloride	GLIPIZIDE AND METFORMIN HYDROCHLORIDE	AvKARE	13be49d2-0ce9-a78a-e557-ded85ddc808f	2025-10-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077270 application number: ANDA077270 ndc (product): 42291-305 ndc (product): 42291-306

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 33 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0093-7455	Glipizide and Metformin Hydrochloride	Glipizide and Metformin Hydrochloride	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-7455	Glipizide and Metformin Hydrochloride	Glipizide and Metformin Hydrochloride	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-7455	Glipizide and Metformin Hydrochloride	Glipizide and Metformin Hydrochloride	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-7455	Glipizide and Metformin Hydrochloride	Glipizide and Metformin Hydrochloride	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-7455	Glipizide and Metformin Hydrochloride	Glipizide and Metformin Hydrochloride	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-7456	Glipizide and Metformin Hydrochloride	Glipizide and Metformin Hydrochloride	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-7456	Glipizide and Metformin Hydrochloride	Glipizide and Metformin Hydrochloride	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-7456	Glipizide and Metformin Hydrochloride	Glipizide and Metformin Hydrochloride	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-7456	Glipizide and Metformin Hydrochloride	Glipizide and Metformin Hydrochloride	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-7456	Glipizide and Metformin Hydrochloride	Glipizide and Metformin Hydrochloride	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-7457	Glipizide and Metformin Hydrochloride	Glipizide and Metformin Hydrochloride	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-7457	Glipizide and Metformin Hydrochloride	Glipizide and Metformin Hydrochloride	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-7457	Glipizide and Metformin Hydrochloride	Glipizide and Metformin Hydrochloride	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-7457	Glipizide and Metformin Hydrochloride	Glipizide and Metformin Hydrochloride	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-7457	Glipizide and Metformin Hydrochloride	Glipizide and Metformin Hydrochloride	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0179-0205	Glipizide and Metformin Hydrochloride	Glipizide and Metformin Hydrochloride	KAISER FOUNDATION HOSPITALS	ANDA	Current
21695-894	Glipizide and Metformin Hydrochloride	Glipizide and Metformin Hydrochloride	Rebel Distributors Corp	ANDA	Current
42291-305	Glipizide and Metformin Hydrochloride	Glipizide and Metformin Hydrochloride	AvKARE, Inc.	ANDA	Current
42291-305	Glipizide and Metformin Hydrochloride	Glipizide and Metformin Hydrochloride	AvKARE, Inc.	ANDA	Current
42291-305	Glipizide and Metformin Hydrochloride	Glipizide and Metformin Hydrochloride	AvKARE	ANDA	Current
42291-305	Glipizide and Metformin Hydrochloride	Glipizide and Metformin Hydrochloride	AvKARE	ANDA	Current
42291-306	Glipizide and Metformin Hydrochloride	Glipizide and Metformin Hydrochloride	AvKARE, Inc.	ANDA	Current
42291-306	Glipizide and Metformin Hydrochloride	Glipizide and Metformin Hydrochloride	AvKARE, Inc.	ANDA	Current
42291-306	Glipizide and Metformin Hydrochloride	Glipizide and Metformin Hydrochloride	AvKARE	ANDA	Current
42291-306	Glipizide and Metformin Hydrochloride	Glipizide and Metformin Hydrochloride	AvKARE	ANDA	Current
50090-1080	Glipizide and Metformin Hydrochloride	Glipizide and Metformin Hydrochloride	A-S Medication Solutions	ANDA	Current
50090-1550	Glipizide and Metformin Hydrochloride	Glipizide and Metformin Hydrochloride	A-S Medication Solutions	ANDA	Current
50436-0874	Glipizide and Metformin Hydrochloride	Glipizide and Metformin Hydrochloride	Unit Dose Services	ANDA	Current
63629-7249	Glipizide and Metformin Hydrochloride	Glipizide and Metformin Hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-7249	Glipizide and Metformin Hydrochloride	Glipizide and Metformin Hydrochloride	Bryant Ranch Prepack	ANDA	Current
70518-0373	Glipizide and Metformin Hydrochloride	Glipizide and Metformin Hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-0373	Glipizide and Metformin Hydrochloride	Glipizide and Metformin Hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-0373	Glipizide and Metformin Hydrochloride	Glipizide and Metformin Hydrochloride	REMEDYREPACK INC.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
31214	ORIG	2005-11-01