Application 206928

Type: ANDA
Sponsor: AUROBINDO PHARMA LTD

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
A206928-001	GLIPIZIDE	GLIPIZIDE	2.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2017-05-12
A206928-002	GLIPIZIDE	GLIPIZIDE	5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2017-05-12
A206928-003	GLIPIZIDE	GLIPIZIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2017-05-12

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A206928-001	AB
A206928-002	AB
A206928-003	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	A206928-001	GLIPIZIDE	2.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2017-05-12	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A206928-002	GLIPIZIDE	5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2017-05-12	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A206928-003	GLIPIZIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2017-05-12	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A206928-001	GLIPIZIDE	2.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2017-05-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206928-002	GLIPIZIDE	5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2017-05-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206928-003	GLIPIZIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2017-05-12	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206928-001	GLIPIZIDE	2.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2017-05-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206928-002	GLIPIZIDE	5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2017-05-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206928-003	GLIPIZIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2017-05-12	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206928-001	GLIPIZIDE	2.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2017-05-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206928-002	GLIPIZIDE	5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2017-05-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206928-003	GLIPIZIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2017-05-12	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206928-001	GLIPIZIDE	2.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2017-05-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206928-002	GLIPIZIDE	5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2017-05-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206928-003	GLIPIZIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2017-05-12	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206928-001	GLIPIZIDE	2.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2017-05-12	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206928-002	GLIPIZIDE	5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2017-05-12	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206928-003	GLIPIZIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2017-05-12	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206928-001	GLIPIZIDE	2.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2017-05-12	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206928-002	GLIPIZIDE	5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2017-05-12	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206928-003	GLIPIZIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2017-05-12	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206928-001	GLIPIZIDE	2.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2017-05-12	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206928-002	GLIPIZIDE	5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2017-05-12	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206928-003	GLIPIZIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2017-05-12	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206928-001	GLIPIZIDE	2.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2017-05-12	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206928-002	GLIPIZIDE	5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2017-05-12	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206928-003	GLIPIZIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2017-05-12	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206928-001	GLIPIZIDE	2.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2017-05-12	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206928-002	GLIPIZIDE	5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2017-05-12	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206928-003	GLIPIZIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2017-05-12	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A206928-001	GLIPIZIDE	2.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2017-05-12	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A206928-002	GLIPIZIDE	5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2017-05-12	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A206928-003	GLIPIZIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2017-05-12	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206928-001	GLIPIZIDE	2.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2017-05-12	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206928-002	GLIPIZIDE	5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2017-05-12	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206928-003	GLIPIZIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2017-05-12	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206928-001	GLIPIZIDE	2.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2017-05-12	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206928-002	GLIPIZIDE	5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2017-05-12	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206928-003	GLIPIZIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2017-05-12	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206928-001	GLIPIZIDE	2.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2017-05-12	`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	A206928-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A206928-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A206928-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A206928-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206928-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206928-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206928-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206928-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206928-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206928-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206928-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206928-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206928-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206928-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206928-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206928-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206928-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206928-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206928-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206928-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206928-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206928-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206928-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206928-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206928-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206928-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206928-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206928-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206928-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206928-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A206928-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A206928-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A206928-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206928-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206928-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206928-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206928-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206928-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206928-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206928-001	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 · 13 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Glipizide	GLIPIZIDE	St. Mary's Medical Park Pharmacy	1b2ef6e2-5e7c-761e-e063-6294a90addd0	2026-06-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206928 application number: ANDA206928
Glipizide	GLIPIZIDE	REMEDYREPACK INC.	0df8f606-97b3-463c-a132-338cf4630a71	2026-06-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206928 application number: ANDA206928
Glipizide	GLIPIZIDE	St. Mary's Medical Park Pharmacy	0ccc17ca-fff8-0449-e063-6294a90af36d	2026-06-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206928 application number: ANDA206928
Glipizide	GLIPIZIDE	Bryant Ranch Prepack	2aa01a7e-a703-426f-9cd3-70b88d0a8e7f	2026-05-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206928 application number: ANDA206928
Glipizide	GLIPIZIDE	Bryant Ranch Prepack	ceb86ebb-d00a-4261-90ad-8751e799d93c	2026-04-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206928 application number: ANDA206928
Glipizide	GLIPIZIDE	Bryant Ranch Prepack	4afa67b2-7f86-4189-93a5-6a605f74540d	2026-04-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206928 application number: ANDA206928
Glipizide	GLIPIZIDE	REMEDYREPACK INC.	667dd68a-d3e7-4b50-bd0a-d17783a090d5	2026-03-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206928 application number: ANDA206928
Glipizide	GLIPIZIDE	Aurobindo Pharma Limited	84794a52-b717-488c-8533-6425c83d405f	2026-01-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206928 application number: ANDA206928
Glipizide	GLIPIZIDE	Northwind Health Company, LLC	0a1e1152-ade7-2092-e063-6394a90a99e7	2025-12-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206928 application number: ANDA206928
Glipizide	GLIPIZIDE	Northwind Health Company, LLC	0effd04d-172c-5d8c-e063-6294a90a93f4	2025-12-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206928 application number: ANDA206928
Glipizide	GLIPIZIDE	American Health Packaging	aaf029d3-027e-4ae8-8ec5-3a4c16f9bd28	2025-04-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206928 application number: ANDA206928
Glipizide	GLIPIZIDE	A-S Medication Solutions	08b01608-73c2-45e0-8de4-c6c401261152	2023-10-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206928 application number: ANDA206928
Glipizide	GLIPIZIDE	A-S Medication Solutions	695c178f-77f0-451e-b718-72b65e495b7e	2023-10-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206928 application number: ANDA206928

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 44 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
50090-4008	Glipizide	Glipizide	A-S Medication Solutions	ANDA	Current
50090-4199	Glipizide	Glipizide	A-S Medication Solutions	ANDA	Current
50090-4297	Glipizide	Glipizide	A-S Medication Solutions	ANDA	Current
50090-4297	Glipizide	Glipizide	A-S Medication Solutions	ANDA	Current
50090-4911	Glipizide	Glipizide	A-S Medication Solutions	ANDA	Current
51655-982	Glipizide	Glipizide	Northwind Pharmaceuticals	ANDA	Current
51655-983	Glipizide	Glipizide	Northwind Pharmaceuticals	ANDA	Current
59651-268	Glipizide	Glipizide	Aurobindo Pharma Limited	ANDA	Current
59651-268	Glipizide	Glipizide	Aurobindo Pharma Limited	ANDA	Current
59651-268	Glipizide	Glipizide	Aurobindo Pharma Limited	ANDA	Current
59651-268	Glipizide	Glipizide	Aurobindo Pharma Limited	ANDA	Current
59651-269	Glipizide	Glipizide	Aurobindo Pharma Limited	ANDA	Current
59651-269	Glipizide	Glipizide	Aurobindo Pharma Limited	ANDA	Current
59651-269	Glipizide	Glipizide	Aurobindo Pharma Limited	ANDA	Current
59651-269	Glipizide	Glipizide	Aurobindo Pharma Limited	ANDA	Current
59651-270	Glipizide	Glipizide	Aurobindo Pharma Limited	ANDA	Current
59651-270	Glipizide	Glipizide	Aurobindo Pharma Limited	ANDA	Current
59651-270	Glipizide	Glipizide	Aurobindo Pharma Limited	ANDA	Current
59651-270	Glipizide	Glipizide	Aurobindo Pharma Limited	ANDA	Current
60687-480	Glipizide	Glipizide	American Health Packaging	ANDA	Current
60687-480	Glipizide	Glipizide	American Health Packaging	ANDA	Current
60687-480	Glipizide	Glipizide	American Health Packaging	ANDA	Current
60687-682	Glipizide	Glipizide	American Health Packaging	ANDA	Current
60760-329	Glipizide	Glipizide	St. Mary's Medical Park Pharmacy	ANDA	Current
65862-888	Glipizide	Glipizide	Aurobindo Pharma Limited	ANDA	Current
65862-888	Glipizide	Glipizide	Aurobindo Pharma Limited	ANDA	Current
65862-889	Glipizide	Glipizide	Aurobindo Pharma Limited	ANDA	Current
65862-889	Glipizide	Glipizide	Aurobindo Pharma Limited	ANDA	Current
65862-890	Glipizide	Glipizide	Aurobindo Pharma Limited	ANDA	Current
65862-890	Glipizide	Glipizide	Aurobindo Pharma Limited	ANDA	Current
68788-7553	Glipizide	Glipizide	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-7553	Glipizide	Glipizide	Preferred Pharmaceuticals, Inc.	ANDA	Current
70518-2573	Glipizide	Glipizide	REMEDYREPACK INC.	ANDA	Current
70518-2573	Glipizide	Glipizide	REMEDYREPACK INC.	ANDA	Current
70518-2573	Glipizide	Glipizide	REMEDYREPACK INC.	ANDA	Current
70518-2624	Glipizide	Glipizide	REMEDYREPACK INC.	ANDA	Current
70518-2624	Glipizide	Glipizide	REMEDYREPACK INC.	ANDA	Current
70518-2624	Glipizide	Glipizide	REMEDYREPACK INC.	ANDA	Current
70518-2888	Glipizide	Glipizide	REMEDYREPACK INC.	ANDA	Current
70518-2888	Glipizide	Glipizide	REMEDYREPACK INC.	ANDA	Current
70518-2888	Glipizide	Glipizide	REMEDYREPACK INC.	ANDA	Current
70934-843	Glipizide	Glipizide	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	ANDA	Current
70934-843	Glipizide	Glipizide	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	ANDA	Current
71335-1592	Glipizide	Glipizide	Bryant Ranch Prepack	ANDA	Current