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 1 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.	667dd68a-d3e7-4b50-bd0a-d17783a090d5	2026-08-27	Warnings, Adverse reactions	Name fallback brand name: Glipizide generic name: GLIPIZIDE
Glipizide	GLIPIZIDE	Bryant Ranch Prepack	00729e82-150a-464a-abe7-a3319721fbdb	2026-08-27	Warnings, Adverse reactions	Name fallback brand name: Glipizide generic name: GLIPIZIDE
Glipizide	GLIPIZIDE	Bryant Ranch Prepack	a59e2aaf-692c-4696-817b-3fed7a9dc52c	2026-08-26	Warnings, Adverse reactions	Name fallback brand name: Glipizide generic name: GLIPIZIDE
Glipizide	GLIPIZIDE	Bryant Ranch Prepack	c0db4c38-6eed-49ca-84ab-7ed89e476822	2026-08-21	Warnings, Adverse reactions	Name fallback brand name: Glipizide generic name: GLIPIZIDE
Glipizide	GLIPIZIDE	REMEDYREPACK INC.	e4831ddb-9680-40cb-a060-4ba77c52d0aa	2026-08-14	Warnings, Adverse reactions	Name fallback brand name: Glipizide generic name: GLIPIZIDE
Glipizide	GLIPIZIDE	REMEDYREPACK INC.	03151cb5-d32b-4484-8f2a-8c5d24c7f6f1	2026-08-05	Warnings, Adverse reactions	Name fallback brand name: Glipizide generic name: GLIPIZIDE
Glipizide	GLIPIZIDE	PD-Rx Pharmaceuticals, Inc.	d9b6464f-6fe6-446e-8150-d0c15c46fee8	2026-07-31	Warnings, Adverse reactions	Name fallback brand name: Glipizide generic name: GLIPIZIDE
Glipizide	GLIPIZIDE	PD-Rx Pharmaceuticals, Inc.	3de8b0a7-b848-40af-8406-fe6924ff41db	2026-07-31	Warnings, Adverse reactions	Name fallback brand name: Glipizide generic name: GLIPIZIDE
Glipizide	GLIPIZIDE	Preferred Pharmaceuticals Inc.	e0de2d19-b24b-46af-a10e-0b78c51350a4	2026-07-31	Warnings, Adverse reactions	Name fallback brand name: Glipizide generic name: GLIPIZIDE
Glipizide	GLIPIZIDE	Golden State Medical Supply, Inc.	d91d021f-f644-eac7-e053-2995a90a81c4	2026-07-27	Warnings, Adverse reactions	Name fallback brand name: Glipizide generic name: GLIPIZIDE
Glucotrol XL	GLIPIZIDE	Roerig	eed99b60-d043-4249-9b2a-f05e46fb588d	2026-07-21	Warnings, Adverse reactions	Name fallback generic name: GLIPIZIDE
Glipizide	GLIPIZIDE	ANI Pharmaceuticals, Inc.	252ba4e0-8dc3-43e3-be00-32570dc095bd	2026-07-13	Warnings, Adverse reactions	Name fallback brand name: Glipizide generic name: GLIPIZIDE
Glipizide	GLIPIZIDE	REMEDYREPACK INC.	c2aadc88-22d2-467c-b2cb-03efb5a1f1c1	2026-07-02	Warnings, Adverse reactions	Name fallback brand name: Glipizide generic name: GLIPIZIDE
Glipizide	GLIPIZIDE	American Health Packaging	ff6805bb-b5f0-46d3-bf1d-3333b63ff1ae	2026-06-24	Warnings, Adverse reactions	Name fallback brand name: Glipizide generic name: GLIPIZIDE
Glipizide	GLIPIZIDE	St. Mary's Medical Park Pharmacy	1b2ef6e2-5e7c-761e-e063-6294a90addd0	2026-06-22	Warnings, Adverse reactions	Name fallback brand name: Glipizide generic name: GLIPIZIDE
Glipizide	GLIPIZIDE	NuCare Pharmaceuticals, Inc.	4c4dfe64-d1c5-65ec-e063-6394a90aead5	2026-06-19	Warnings, Adverse reactions	Name fallback brand name: Glipizide generic name: GLIPIZIDE
Glipizide	GLIPIZIDE	Bryant Ranch Prepack	06fb6c56-5609-41d9-8389-eba81432218d	2026-06-11	Warnings, Adverse reactions	Name fallback brand name: Glipizide generic name: GLIPIZIDE
Glipizide	GLIPIZIDE	Bryant Ranch Prepack	5ca7e38b-84cb-4043-b97e-e2f5cd82b442	2026-06-11	Warnings, Adverse reactions	Name fallback brand name: Glipizide generic name: GLIPIZIDE
Glipizide	GLIPIZIDE	Coupler LLC	53e650f1-f755-e3ad-e063-6294a90ae309	2026-06-10	Warnings, Adverse reactions	Name fallback brand name: Glipizide generic name: GLIPIZIDE
Glipizide	GLIPIZIDE	REMEDYREPACK INC.	0df8f606-97b3-463c-a132-338cf4630a71	2026-06-10	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.