Application 203499

Type: ANDA
Sponsor: ZYDUS PHARMS

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 42.

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
A203499-001	GLIPIZIDE	GLIPIZIDE	2.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-07-16
A203499-002	GLIPIZIDE	GLIPIZIDE	5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-07-16
A203499-003	GLIPIZIDE	GLIPIZIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-07-16

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A203499-001	AB
A203499-002	AB
A203499-003	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 · 126 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
2026-08-18 06:07:40	2026-07	A203499-001	GLIPIZIDE	2.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-07-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203499-002	GLIPIZIDE	5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-07-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203499-003	GLIPIZIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-07-16	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A203499-001	GLIPIZIDE	2.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-07-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203499-002	GLIPIZIDE	5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-07-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203499-003	GLIPIZIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-07-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203499-001	GLIPIZIDE	2.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-07-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203499-002	GLIPIZIDE	5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-07-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203499-003	GLIPIZIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-07-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203499-001	GLIPIZIDE	2.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-07-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203499-002	GLIPIZIDE	5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-07-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203499-003	GLIPIZIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-07-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203499-001	GLIPIZIDE	2.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-07-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203499-002	GLIPIZIDE	5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-07-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203499-003	GLIPIZIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-07-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203499-001	GLIPIZIDE	2.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-07-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203499-002	GLIPIZIDE	5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-07-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203499-003	GLIPIZIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-07-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203499-001	GLIPIZIDE	2.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-07-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203499-002	GLIPIZIDE	5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-07-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203499-003	GLIPIZIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-07-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203499-001	GLIPIZIDE	2.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-07-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203499-002	GLIPIZIDE	5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-07-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203499-003	GLIPIZIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-07-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203499-001	GLIPIZIDE	2.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-07-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203499-002	GLIPIZIDE	5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-07-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203499-003	GLIPIZIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-07-16	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203499-001	GLIPIZIDE	2.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-07-16	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203499-002	GLIPIZIDE	5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-07-16	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203499-003	GLIPIZIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-07-16	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203499-001	GLIPIZIDE	2.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-07-16	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203499-002	GLIPIZIDE	5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-07-16	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203499-003	GLIPIZIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-07-16	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203499-001	GLIPIZIDE	2.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-07-16	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203499-002	GLIPIZIDE	5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-07-16	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203499-003	GLIPIZIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-07-16	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203499-001	GLIPIZIDE	2.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-07-16	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203499-002	GLIPIZIDE	5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-07-16	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203499-003	GLIPIZIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-07-16	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203499-001	GLIPIZIDE	2.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-07-16	`1e350fbaab3a…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 126 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A203499-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203499-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203499-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A203499-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203499-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203499-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203499-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203499-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203499-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203499-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203499-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203499-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203499-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203499-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203499-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203499-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203499-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203499-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203499-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203499-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203499-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203499-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203499-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203499-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203499-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203499-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203499-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203499-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203499-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203499-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203499-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203499-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203499-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203499-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203499-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203499-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203499-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203499-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203499-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203499-001	AB	1	`1e350fbaab3a…`

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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Glipizide	GLIPIZIDE	REMEDYREPACK INC.	e4831ddb-9680-40cb-a060-4ba77c52d0aa	2026-08-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203499 application number: ANDA203499
Glipizide	GLIPIZIDE	REMEDYREPACK INC.	e593552f-9817-4cb5-b491-31ea57dea4b8	2026-02-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203499 application number: ANDA203499
Glipizide	GLIPIZIDE	Northstar Rx LLC.	915636a4-092e-4e2e-9bc0-0d387d996977	2026-01-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203499 application number: ANDA203499 ndc (product): 16714-894 ndc (product): 16714-896 ndc (product): 16714-895
Glipizide	GLIPIZIDE	A-S Medication Solutions	5014a2d7-e0d3-4e84-9a3e-c90b398b8c6c	2023-12-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203499 application number: ANDA203499
Glipizide	GLIPIZIDE	A-S Medication Solutions	15308fc4-11e3-4cd5-8f04-ab8e3433cc7d	2023-12-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203499 application number: ANDA203499

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 35 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
16714-894	Glipizide	Glipizide	Northstar Rx LLC.	ANDA	Current
16714-894	Glipizide	Glipizide	Northstar Rx LLC.	ANDA	Current
16714-894	Glipizide	Glipizide	Northstar Rx LLC.	ANDA	Current
16714-895	Glipizide	Glipizide	Northstar Rx LLC.	ANDA	Current
16714-895	Glipizide	Glipizide	Northstar Rx LLC.	ANDA	Current
16714-895	Glipizide	Glipizide	Northstar Rx LLC.	ANDA	Current
16714-896	Glipizide	Glipizide	Northstar Rx LLC.	ANDA	Current
16714-896	Glipizide	Glipizide	Northstar Rx LLC.	ANDA	Current
16714-896	Glipizide	Glipizide	Northstar Rx LLC.	ANDA	Current
50090-5377	Glipizide	Glipizide	A-S Medication Solutions	ANDA	Current
50090-5377	Glipizide	Glipizide	A-S Medication Solutions	ANDA	Current
61919-850	GLIPIZIDE	GLIPIZIDE	Direct_Rx	ANDA	Current
68071-4994	Glipizide	Glipizide	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-4994	Glipizide	Glipizide	NuCare Pharmaceuticals,Inc.	ANDA	Current
68382-335	Glipizide	Glipizide	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-335	Glipizide	Glipizide	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-335	Glipizide	Glipizide	Zydus Pharmaceuticals USA Inc.	ANDA	Current
68382-336	Glipizide	Glipizide	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-336	Glipizide	Glipizide	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-336	Glipizide	Glipizide	Zydus Pharmaceuticals USA Inc.	ANDA	Current
68382-337	Glipizide	Glipizide	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-337	Glipizide	Glipizide	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-337	Glipizide	Glipizide	Zydus Pharmaceuticals USA Inc.	ANDA	Current
70771-1098	Glipizide	Glipizide	Cadila Healthcare Limited	ANDA	Current
70771-1098	Glipizide	Glipizide	Cadila Healthcare Limited	ANDA	Current
70771-1098	Glipizide	Glipizide	Zydus Lifesciences Limited	ANDA	Current
70771-1098	Glipizide	Glipizide	Cadila Healthcare Limited	ANDA	Current
70771-1099	Glipizide	Glipizide	Cadila Healthcare Limited	ANDA	Current
70771-1099	Glipizide	Glipizide	Cadila Healthcare Limited	ANDA	Current
70771-1099	Glipizide	Glipizide	Zydus Lifesciences Limited	ANDA	Current
70771-1099	Glipizide	Glipizide	Cadila Healthcare Limited	ANDA	Current
70771-1100	Glipizide	Glipizide	Cadila Healthcare Limited	ANDA	Current
70771-1100	Glipizide	Glipizide	Cadila Healthcare Limited	ANDA	Current
70771-1100	Glipizide	Glipizide	Zydus Lifesciences Limited	ANDA	Current
70771-1100	Glipizide	Glipizide	Cadila Healthcare Limited	ANDA	Current