Application 078905

Type: ANDA
Sponsor: ZYDUS PHARMS USA INC

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	No

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	Approval date
A078905-001	GLIPIZIDE AND METFORMIN HYDROCHLORIDE	GLIPIZIDE; METFORMIN HYDROCHLORIDE	2.5MG;250MG	TABLET / ORAL	AB	2011-01-31
A078905-002	GLIPIZIDE AND METFORMIN HYDROCHLORIDE	GLIPIZIDE; METFORMIN HYDROCHLORIDE	2.5MG;500MG	TABLET / ORAL	AB	2011-01-31
A078905-003	GLIPIZIDE AND METFORMIN HYDROCHLORIDE	GLIPIZIDE; METFORMIN HYDROCHLORIDE	5MG;500MG	TABLET / ORAL	AB	2011-01-31

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A078905-001	AB
A078905-002	AB
A078905-003	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	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A078905-001	GLIPIZIDE AND METFORMIN HYDROCHLORIDE	2.5MG;250MG	TABLET / ORAL	AB	2011-01-31	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078905-002	GLIPIZIDE AND METFORMIN HYDROCHLORIDE	2.5MG;500MG	TABLET / ORAL	AB	2011-01-31	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078905-003	GLIPIZIDE AND METFORMIN HYDROCHLORIDE	5MG;500MG	TABLET / ORAL	AB	2011-01-31	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A078905-001	GLIPIZIDE AND METFORMIN HYDROCHLORIDE	2.5MG;250MG	TABLET / ORAL	AB	2011-01-31	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078905-002	GLIPIZIDE AND METFORMIN HYDROCHLORIDE	2.5MG;500MG	TABLET / ORAL	AB	2011-01-31	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078905-003	GLIPIZIDE AND METFORMIN HYDROCHLORIDE	5MG;500MG	TABLET / ORAL	AB	2011-01-31	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078905-001	GLIPIZIDE AND METFORMIN HYDROCHLORIDE	2.5MG;250MG	TABLET / ORAL	AB	2011-01-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078905-002	GLIPIZIDE AND METFORMIN HYDROCHLORIDE	2.5MG;500MG	TABLET / ORAL	AB	2011-01-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078905-003	GLIPIZIDE AND METFORMIN HYDROCHLORIDE	5MG;500MG	TABLET / ORAL	AB	2011-01-31	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078905-001	GLIPIZIDE AND METFORMIN HYDROCHLORIDE	2.5MG;250MG	TABLET / ORAL	AB	2011-01-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078905-002	GLIPIZIDE AND METFORMIN HYDROCHLORIDE	2.5MG;500MG	TABLET / ORAL	AB	2011-01-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078905-003	GLIPIZIDE AND METFORMIN HYDROCHLORIDE	5MG;500MG	TABLET / ORAL	AB	2011-01-31	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078905-001	GLIPIZIDE AND METFORMIN HYDROCHLORIDE	2.5MG;250MG	TABLET / ORAL	AB	2011-01-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078905-002	GLIPIZIDE AND METFORMIN HYDROCHLORIDE	2.5MG;500MG	TABLET / ORAL	AB	2011-01-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078905-003	GLIPIZIDE AND METFORMIN HYDROCHLORIDE	5MG;500MG	TABLET / ORAL	AB	2011-01-31	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078905-001	GLIPIZIDE AND METFORMIN HYDROCHLORIDE	2.5MG;250MG	TABLET / ORAL	AB	2011-01-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078905-002	GLIPIZIDE AND METFORMIN HYDROCHLORIDE	2.5MG;500MG	TABLET / ORAL	AB	2011-01-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078905-003	GLIPIZIDE AND METFORMIN HYDROCHLORIDE	5MG;500MG	TABLET / ORAL	AB	2011-01-31	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078905-001	GLIPIZIDE AND METFORMIN HYDROCHLORIDE	2.5MG;250MG	TABLET / ORAL	AB	2011-01-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078905-002	GLIPIZIDE AND METFORMIN HYDROCHLORIDE	2.5MG;500MG	TABLET / ORAL	AB	2011-01-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078905-003	GLIPIZIDE AND METFORMIN HYDROCHLORIDE	5MG;500MG	TABLET / ORAL	AB	2011-01-31	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078905-001	GLIPIZIDE AND METFORMIN HYDROCHLORIDE	2.5MG;250MG	TABLET / ORAL	AB	2011-01-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078905-002	GLIPIZIDE AND METFORMIN HYDROCHLORIDE	2.5MG;500MG	TABLET / ORAL	AB	2011-01-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078905-003	GLIPIZIDE AND METFORMIN HYDROCHLORIDE	5MG;500MG	TABLET / ORAL	AB	2011-01-31	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078905-001	GLIPIZIDE AND METFORMIN HYDROCHLORIDE	2.5MG;250MG	TABLET / ORAL	AB	2011-01-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078905-002	GLIPIZIDE AND METFORMIN HYDROCHLORIDE	2.5MG;500MG	TABLET / ORAL	AB	2011-01-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078905-003	GLIPIZIDE AND METFORMIN HYDROCHLORIDE	5MG;500MG	TABLET / ORAL	AB	2011-01-31	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078905-001	GLIPIZIDE AND METFORMIN HYDROCHLORIDE	2.5MG;250MG	TABLET / ORAL	AB	2011-01-31	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078905-002	GLIPIZIDE AND METFORMIN HYDROCHLORIDE	2.5MG;500MG	TABLET / ORAL	AB	2011-01-31	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078905-003	GLIPIZIDE AND METFORMIN HYDROCHLORIDE	5MG;500MG	TABLET / ORAL	AB	2011-01-31	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078905-001	GLIPIZIDE AND METFORMIN HYDROCHLORIDE	2.5MG;250MG	TABLET / ORAL	AB	2011-01-31	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078905-002	GLIPIZIDE AND METFORMIN HYDROCHLORIDE	2.5MG;500MG	TABLET / ORAL	AB	2011-01-31	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078905-003	GLIPIZIDE AND METFORMIN HYDROCHLORIDE	5MG;500MG	TABLET / ORAL	AB	2011-01-31	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078905-001	GLIPIZIDE AND METFORMIN HYDROCHLORIDE	2.5MG;250MG	TABLET / ORAL	AB	2011-01-31	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078905-002	GLIPIZIDE AND METFORMIN HYDROCHLORIDE	2.5MG;500MG	TABLET / ORAL	AB	2011-01-31	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078905-003	GLIPIZIDE AND METFORMIN HYDROCHLORIDE	5MG;500MG	TABLET / ORAL	AB	2011-01-31	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078905-001	GLIPIZIDE AND METFORMIN HYDROCHLORIDE	2.5MG;250MG	TABLET / ORAL	AB	2011-01-31	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078905-002	GLIPIZIDE AND METFORMIN HYDROCHLORIDE	2.5MG;500MG	TABLET / ORAL	AB	2011-01-31	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078905-003	GLIPIZIDE AND METFORMIN HYDROCHLORIDE	5MG;500MG	TABLET / ORAL	AB	2011-01-31	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078905-001	GLIPIZIDE AND METFORMIN HYDROCHLORIDE	2.5MG;250MG	TABLET / ORAL	AB	2011-01-31	`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	A078905-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078905-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078905-003	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A078905-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078905-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078905-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078905-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078905-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078905-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078905-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078905-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078905-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078905-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078905-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078905-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078905-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078905-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078905-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078905-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078905-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078905-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078905-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078905-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078905-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078905-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078905-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078905-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078905-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078905-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078905-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078905-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078905-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078905-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078905-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078905-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078905-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078905-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078905-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078905-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078905-001	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 · 3 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	Zydus Pharmaceuticals USA Inc.	1b18b903-eb52-4d08-b4a5-f984957eb116	2026-06-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078905 application number: ANDA078905 ndc (product): 68382-186 ndc (product): 68382-184 ndc (product): 68382-185
Glipizide and Metformin Hydrochloride	GLIPIZIDE AND METFORMIN HYDROCHLORIDE	A-S Medication Solutions	4a2d814b-93a1-4487-b789-dbafe9f0ffd3	2026-03-07	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078905 application number: ANDA078905 ndc (product): 50090-2556 ndc (product): 50090-2492
Glipizide and Metformin Hydrochloride	GLIPIZIDE AND METFORMIN HYDROCHLORIDE	Zydus Lifesciences Limited	bd2e1c06-424b-4222-b723-90ffdcc3983c	2024-11-30		Exact identifier application applno (ANDA): 078905 application number: ANDA078905 ndc (product): 65841-660 ndc (product): 65841-661 ndc (product): 65841-659

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
50090-2492	Glipizide and Metformin Hydrochloride	Glipizide and Metformin Hydrochloride	A-S Medication Solutions	ANDA	Current
50090-2492	Glipizide and Metformin Hydrochloride	Glipizide and Metformin Hydrochloride	A-S Medication Solutions	ANDA	Current
50090-2492	Glipizide and Metformin Hydrochloride	Glipizide and Metformin Hydrochloride	A-S Medication Solutions	ANDA	Current
50090-2556	Glipizide and Metformin Hydrochloride	Glipizide and Metformin Hydrochloride	A-S Medication Solutions	ANDA	Current
50090-2556	Glipizide and Metformin Hydrochloride	Glipizide and Metformin Hydrochloride	A-S Medication Solutions	ANDA	Current
50090-2556	Glipizide and Metformin Hydrochloride	Glipizide and Metformin Hydrochloride	A-S Medication Solutions	ANDA	Current
65841-659	Glipizide and Metformin Hydrochloride	Glipizide and Metformin Hydrochloride	Cadila Healthcare Limited	ANDA	Current
65841-659	Glipizide and Metformin Hydrochloride	Glipizide and Metformin Hydrochloride	Zydus Lifesciences Limited	ANDA	Current
65841-659	Glipizide and Metformin Hydrochloride	Glipizide and Metformin Hydrochloride	Cadila Healthcare Limited	ANDA	Current
65841-659	Glipizide and Metformin Hydrochloride	Glipizide and Metformin Hydrochloride	Cadila Healthcare Limited	ANDA	Current
65841-660	Glipizide and Metformin Hydrochloride	Glipizide and Metformin Hydrochloride	Cadila Healthcare Limited	ANDA	Current
65841-660	Glipizide and Metformin Hydrochloride	Glipizide and Metformin Hydrochloride	Zydus Lifesciences Limited	ANDA	Current
65841-660	Glipizide and Metformin Hydrochloride	Glipizide and Metformin Hydrochloride	Cadila Healthcare Limited	ANDA	Current
65841-660	Glipizide and Metformin Hydrochloride	Glipizide and Metformin Hydrochloride	Cadila Healthcare Limited	ANDA	Current
65841-661	Glipizide and Metformin Hydrochloride	Glipizide and Metformin Hydrochloride	Cadila Healthcare Limited	ANDA	Current
65841-661	Glipizide and Metformin Hydrochloride	Glipizide and Metformin Hydrochloride	Zydus Lifesciences Limited	ANDA	Current
65841-661	Glipizide and Metformin Hydrochloride	Glipizide and Metformin Hydrochloride	Cadila Healthcare Limited	ANDA	Current
65841-661	Glipizide and Metformin Hydrochloride	Glipizide and Metformin Hydrochloride	Cadila Healthcare Limited	ANDA	Current
68382-184	Glipizide and Metformin Hydrochloride	Glipizide and Metformin Hydrochloride	Zydus Pharmaceuticals USA Inc.	ANDA	Current
68382-184	Glipizide and Metformin Hydrochloride	Glipizide and Metformin Hydrochloride	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-184	Glipizide and Metformin Hydrochloride	Glipizide and Metformin Hydrochloride	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-185	Glipizide and Metformin Hydrochloride	Glipizide and Metformin Hydrochloride	Zydus Pharmaceuticals USA Inc.	ANDA	Current
68382-185	Glipizide and Metformin Hydrochloride	Glipizide and Metformin Hydrochloride	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-185	Glipizide and Metformin Hydrochloride	Glipizide and Metformin Hydrochloride	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-186	Glipizide and Metformin Hydrochloride	Glipizide and Metformin Hydrochloride	Zydus Pharmaceuticals USA Inc.	ANDA	Current
68382-186	Glipizide and Metformin Hydrochloride	Glipizide and Metformin Hydrochloride	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-186	Glipizide and Metformin Hydrochloride	Glipizide and Metformin Hydrochloride	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
70518-0908	Glipizide and Metformin Hydrochloride	Glipizide and Metformin Hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-0908	Glipizide and Metformin Hydrochloride	Glipizide and Metformin Hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-0908	Glipizide and Metformin Hydrochloride	Glipizide and Metformin Hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-0908	Glipizide and Metformin Hydrochloride	Glipizide and Metformin Hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-0908	Glipizide and Metformin Hydrochloride	Glipizide and Metformin Hydrochloride	REMEDYREPACK INC.	ANDA	Current
71335-1778	Glipizide and Metformin Hydrochloride	Glipizide and Metformin Hydrochloride	Bryant Ranch Prepack	ANDA	Current