Application 202298

Type: ANDA
Sponsor: MYLAN

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	GLIPIZIDE	GLIPIZIDE	TABLET, EXTENDED RELEASE;ORAL	2.5MG	No	No
002	GLIPIZIDE	GLIPIZIDE	TABLET, EXTENDED RELEASE;ORAL	5MG	No	No
003	GLIPIZIDE	GLIPIZIDE	TABLET, EXTENDED RELEASE;ORAL	10MG	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	Approval date
A202298-001	GLIPIZIDE	GLIPIZIDE	2.5MG	TABLET, EXTENDED RELEASE / ORAL	2015-05-19
A202298-002	GLIPIZIDE	GLIPIZIDE	5MG	TABLET, EXTENDED RELEASE / ORAL	2015-05-19
A202298-003	GLIPIZIDE	GLIPIZIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	2015-05-19

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	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A202298-001	GLIPIZIDE	2.5MG	TABLET, EXTENDED RELEASE / ORAL	2015-05-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A202298-002	GLIPIZIDE	5MG	TABLET, EXTENDED RELEASE / ORAL	2015-05-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A202298-003	GLIPIZIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	2015-05-19	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A202298-001	GLIPIZIDE	2.5MG	TABLET, EXTENDED RELEASE / ORAL	2015-05-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202298-002	GLIPIZIDE	5MG	TABLET, EXTENDED RELEASE / ORAL	2015-05-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202298-003	GLIPIZIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	2015-05-19	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A202298-001	GLIPIZIDE	2.5MG	TABLET, EXTENDED RELEASE / ORAL	2015-05-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202298-002	GLIPIZIDE	5MG	TABLET, EXTENDED RELEASE / ORAL	2015-05-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202298-003	GLIPIZIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	2015-05-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202298-001	GLIPIZIDE	2.5MG	TABLET, EXTENDED RELEASE / ORAL	2015-05-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202298-002	GLIPIZIDE	5MG	TABLET, EXTENDED RELEASE / ORAL	2015-05-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202298-003	GLIPIZIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	2015-05-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202298-001	GLIPIZIDE	2.5MG	TABLET, EXTENDED RELEASE / ORAL	2015-05-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202298-002	GLIPIZIDE	5MG	TABLET, EXTENDED RELEASE / ORAL	2015-05-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202298-003	GLIPIZIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	2015-05-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202298-001	GLIPIZIDE	2.5MG	TABLET, EXTENDED RELEASE / ORAL	2015-05-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202298-002	GLIPIZIDE	5MG	TABLET, EXTENDED RELEASE / ORAL	2015-05-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202298-003	GLIPIZIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	2015-05-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202298-001	GLIPIZIDE	2.5MG	TABLET, EXTENDED RELEASE / ORAL	2015-05-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202298-002	GLIPIZIDE	5MG	TABLET, EXTENDED RELEASE / ORAL	2015-05-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202298-003	GLIPIZIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	2015-05-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202298-001	GLIPIZIDE	2.5MG	TABLET, EXTENDED RELEASE / ORAL	2015-05-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202298-002	GLIPIZIDE	5MG	TABLET, EXTENDED RELEASE / ORAL	2015-05-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202298-003	GLIPIZIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	2015-05-19	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202298-001	GLIPIZIDE	2.5MG	TABLET, EXTENDED RELEASE / ORAL	2015-05-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202298-002	GLIPIZIDE	5MG	TABLET, EXTENDED RELEASE / ORAL	2015-05-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202298-003	GLIPIZIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	2015-05-19	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202298-001	GLIPIZIDE	2.5MG	TABLET, EXTENDED RELEASE / ORAL	2015-05-19	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202298-002	GLIPIZIDE	5MG	TABLET, EXTENDED RELEASE / ORAL	2015-05-19	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202298-003	GLIPIZIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	2015-05-19	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202298-001	GLIPIZIDE	2.5MG	TABLET, EXTENDED RELEASE / ORAL	2015-05-19	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202298-002	GLIPIZIDE	5MG	TABLET, EXTENDED RELEASE / ORAL	2015-05-19	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202298-003	GLIPIZIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	2015-05-19	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202298-001	GLIPIZIDE	2.5MG	TABLET, EXTENDED RELEASE / ORAL	2015-05-19	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202298-002	GLIPIZIDE	5MG	TABLET, EXTENDED RELEASE / ORAL	2015-05-19	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202298-003	GLIPIZIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	2015-05-19	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202298-001	GLIPIZIDE	2.5MG	TABLET, EXTENDED RELEASE / ORAL	2015-05-19	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202298-002	GLIPIZIDE	5MG	TABLET, EXTENDED RELEASE / ORAL	2015-05-19	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202298-003	GLIPIZIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	2015-05-19	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202298-001	GLIPIZIDE	2.5MG	TABLET, EXTENDED RELEASE / ORAL	2015-05-19	`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 3 of 6 · 102 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Glipizide	GLIPIZIDE	REMEDYREPACK INC.	e593552f-9817-4cb5-b491-31ea57dea4b8	2026-02-24	Warnings, Adverse reactions	Name fallback brand name: Glipizide generic name: GLIPIZIDE
Glipizide	GLIPIZIDE	A-S Medication Solutions	9c9a3688-6de9-41db-af82-c4aa9b5b3f92	2026-02-20	Warnings, Adverse reactions	Name fallback brand name: Glipizide generic name: GLIPIZIDE
Glipizide	GLIPIZIDE	PD-Rx Pharmaceuticals, Inc.	f60b0690-aca9-40ec-956e-bd2ecc35ec54	2026-02-16	Warnings, Adverse reactions	Name fallback brand name: Glipizide generic name: GLIPIZIDE
Glipizide	GLIPIZIDE	A-S Medication Solutions	383540fd-2931-49bf-8009-25e8f7fc9bda	2026-02-10	Warnings, Adverse reactions	Name fallback brand name: Glipizide generic name: GLIPIZIDE
Glipizide	GLIPIZIDE	A-S Medication Solutions	a38cfe61-4aa5-498c-bca5-03a8213303bb	2026-02-10	Warnings, Adverse reactions	Name fallback brand name: Glipizide generic name: GLIPIZIDE
Glipizide	GLIPIZIDE	REMEDYREPACK INC.	bde478e6-e290-47e0-9241-ce88d927633e	2026-02-04	Warnings, Adverse reactions	Name fallback brand name: Glipizide generic name: GLIPIZIDE
Glipizide	GLIPIZIDE	Preferred Pharmaceuticals Inc.	410bf280-838d-45af-9b60-15f94ded7581	2026-01-28	Warnings, Adverse reactions	Name fallback brand name: Glipizide generic name: GLIPIZIDE
Glipizide	GLIPIZIDE	Northwind Health Company, LLC	0ed5ed22-dd53-495d-bc10-0bede4d87926	2026-01-19	Warnings, Adverse reactions	Name fallback brand name: Glipizide generic name: GLIPIZIDE
Glipizide	GLIPIZIDE	Rising Pharma Holdings, Inc.	0ffe361a-c99b-4f68-a7e2-a67a71c0c496	2026-01-17	Warnings, Adverse reactions	Name fallback brand name: Glipizide generic name: GLIPIZIDE
Glipizide	GLIPIZIDE	AvPAK	aa1b16bf-e01c-d539-e053-2995a90a2735	2026-01-08	Warnings, Adverse reactions	Name fallback brand name: Glipizide generic name: GLIPIZIDE
Glipizide	GLIPIZIDE	Aurobindo Pharma Limited	84794a52-b717-488c-8533-6425c83d405f	2026-01-08	Warnings, Adverse reactions	Name fallback brand name: Glipizide generic name: GLIPIZIDE
Glipizide	GLIPIZIDE	Northstar Rx LLC.	915636a4-092e-4e2e-9bc0-0d387d996977	2026-01-05	Warnings, Adverse reactions	Name fallback brand name: Glipizide generic name: GLIPIZIDE
Glipizide	GLIPIZIDE	Northwind Health Company, LLC	c16edad6-4271-6ff0-e053-2a95a90a0240	2026-01-01	Warnings, Adverse reactions	Name fallback brand name: Glipizide generic name: GLIPIZIDE
Glipizide	GLIPIZIDE	Northwind Health Company, LLC	3bb3b80a-30e8-62fe-e054-00144ff8d46c	2026-01-01	Warnings, Adverse reactions	Name fallback brand name: Glipizide generic name: GLIPIZIDE
Glipizide	GLIPIZIDE	Northwind Health Company, LLC	ab2f4ea6-46e8-268a-e053-2995a90a3977	2026-01-01	Warnings, Adverse reactions	Name fallback brand name: Glipizide generic name: GLIPIZIDE
Glipizide	GLIPIZIDE	Northwind Health Company, LLC	ff9b3b7a-5ab1-45ec-e053-6294a90af426	2026-01-01	Warnings, Adverse reactions	Name fallback brand name: Glipizide generic name: GLIPIZIDE
Glipizide	GLIPIZIDE	Proficient Rx LP	f5d7a98c-d1d4-43b9-8d7e-830a33ae0c24	2026-01-01	Warnings, Adverse reactions	Name fallback brand name: Glipizide generic name: GLIPIZIDE
Glipizide	GLIPIZIDE	Northwind Health Company, LLC	0a1e1152-ade7-2092-e063-6394a90a99e7	2025-12-26	Warnings, Adverse reactions	Name fallback brand name: Glipizide generic name: GLIPIZIDE
Glipizide	GLIPIZIDE	Northwind Health Company, LLC	0effd04d-172c-5d8c-e063-6294a90a93f4	2025-12-26	Warnings, Adverse reactions	Name fallback brand name: Glipizide generic name: GLIPIZIDE
Glipizide	GLIPIZIDE	A-S Medication Solutions	16fb8bc7-1db1-477e-a201-b3b678b8a84c	2025-12-03	Warnings, Adverse reactions	Name fallback brand name: Glipizide generic name: GLIPIZIDE

Reported adverse events (FAERS/openFDA)#

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