Application 077820

Type: ANDA
Sponsor: SUN PHARM INDS INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	GLIPIZIDE	GLIPIZIDE	TABLET;ORAL	5MG	No	No
002	GLIPIZIDE	GLIPIZIDE	TABLET;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 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A077820-001	GLIPIZIDE	GLIPIZIDE	5MG	TABLET / ORAL			2006-07-11
A077820-002	GLIPIZIDE	GLIPIZIDE	10MG	TABLET / ORAL			2006-07-11

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 3 · 86 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	A077820-001	GLIPIZIDE	5MG	TABLET / ORAL		2006-07-11	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077820-002	GLIPIZIDE	10MG	TABLET / ORAL		2006-07-11	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A077820-001	GLIPIZIDE	5MG	TABLET / ORAL		2006-07-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077820-002	GLIPIZIDE	10MG	TABLET / ORAL		2006-07-11	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077820-001	GLIPIZIDE	5MG	TABLET / ORAL		2006-07-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077820-002	GLIPIZIDE	10MG	TABLET / ORAL		2006-07-11	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077820-001	GLIPIZIDE	5MG	TABLET / ORAL		2006-07-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077820-002	GLIPIZIDE	10MG	TABLET / ORAL		2006-07-11	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077820-001	GLIPIZIDE	5MG	TABLET / ORAL		2006-07-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077820-002	GLIPIZIDE	10MG	TABLET / ORAL		2006-07-11	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077820-001	GLIPIZIDE	5MG	TABLET / ORAL		2006-07-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077820-002	GLIPIZIDE	10MG	TABLET / ORAL		2006-07-11	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077820-001	GLIPIZIDE	5MG	TABLET / ORAL		2006-07-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077820-002	GLIPIZIDE	10MG	TABLET / ORAL		2006-07-11	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077820-001	GLIPIZIDE	5MG	TABLET / ORAL		2006-07-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077820-002	GLIPIZIDE	10MG	TABLET / ORAL		2006-07-11	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077820-001	GLIPIZIDE	5MG	TABLET / ORAL		2006-07-11	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077820-002	GLIPIZIDE	10MG	TABLET / ORAL		2006-07-11	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077820-001	GLIPIZIDE	5MG	TABLET / ORAL		2006-07-11	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077820-002	GLIPIZIDE	10MG	TABLET / ORAL		2006-07-11	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077820-001	GLIPIZIDE	5MG	TABLET / ORAL		2006-07-11	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077820-002	GLIPIZIDE	10MG	TABLET / ORAL		2006-07-11	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077820-001	GLIPIZIDE	5MG	TABLET / ORAL		2006-07-11	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077820-002	GLIPIZIDE	10MG	TABLET / ORAL		2006-07-11	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077820-001	GLIPIZIDE	5MG	TABLET / ORAL		2006-07-11	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077820-002	GLIPIZIDE	10MG	TABLET / ORAL		2006-07-11	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077820-001	GLIPIZIDE	5MG	TABLET / ORAL		2006-07-11	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077820-002	GLIPIZIDE	10MG	TABLET / ORAL		2006-07-11	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077820-001	GLIPIZIDE	5MG	TABLET / ORAL		2006-07-11	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077820-002	GLIPIZIDE	10MG	TABLET / ORAL		2006-07-11	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077820-001	GLIPIZIDE	5MG	TABLET / ORAL		2006-07-11	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A077820-002	GLIPIZIDE	10MG	TABLET / ORAL		2006-07-11	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077820-001	GLIPIZIDE	5MG	TABLET / ORAL	AB	2006-07-11	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077820-002	GLIPIZIDE	10MG	TABLET / ORAL	AB	2006-07-11	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077820-001	GLIPIZIDE	5MG	TABLET / ORAL	AB	2006-07-11	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A077820-002	GLIPIZIDE	10MG	TABLET / ORAL	AB	2006-07-11	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077820-001	GLIPIZIDE	5MG	TABLET / ORAL	AB	2006-07-11	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A077820-002	GLIPIZIDE	10MG	TABLET / ORAL	AB	2006-07-11	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077820-001	GLIPIZIDE	5MG	TABLET / ORAL	AB	2006-07-11	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A077820-002	GLIPIZIDE	10MG	TABLET / ORAL	AB	2006-07-11	`74a2ff9319b5…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 46 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077820-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077820-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077820-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A077820-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077820-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A077820-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077820-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A077820-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A077820-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A077820-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A077820-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A077820-002	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A077820-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A077820-002	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A077820-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A077820-002	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A077820-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A077820-002	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A077820-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A077820-002	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A077820-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A077820-002	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A077820-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A077820-002	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A077820-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A077820-002	AB	1	`ea99ee380514…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A077820-001	AB	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A077820-002	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A077820-001	AB	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A077820-002	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A077820-001	AB	1	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A077820-002	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A077820-001	AB	1	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A077820-002	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A077820-001	AB	1	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A077820-002	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A077820-001	AB	1	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A077820-002	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A077820-001	AB	1	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A077820-002	AB	1	`3a93d1ddd44b…`

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 2 of 6 · 102 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Glipizide	GLIPIZIDE	PD-Rx Pharmaceuticals, Inc.	c8cfd137-7b41-460f-a463-141c9d1985ff	2026-06-04	Warnings, Adverse reactions	Name fallback brand name: Glipizide generic name: GLIPIZIDE
Glipizide	GLIPIZIDE	St. Mary's Medical Park Pharmacy	0ccc17ca-fff8-0449-e063-6294a90af36d	2026-06-03	Warnings, Adverse reactions	Name fallback brand name: Glipizide generic name: GLIPIZIDE
Glipizide	GLIPIZIDE	Bryant Ranch Prepack	9b405ff3-6ce5-460a-9406-db92e0e6ab1b	2026-05-21	Warnings, Adverse reactions	Name fallback brand name: Glipizide generic name: GLIPIZIDE
Glipizide	GLIPIZIDE	A-S Medication Solutions	69a21bd3-3364-4035-b098-3808cc8cf8b2	2026-05-17	Warnings, Adverse reactions	Name fallback brand name: Glipizide generic name: GLIPIZIDE
Glipizide	GLIPIZIDE	A-S Medication Solutions	c582d7d0-4db0-4296-8131-baefd1a671b2	2026-05-17	Warnings, Adverse reactions	Name fallback brand name: Glipizide generic name: GLIPIZIDE
Glipizide	GLIPIZIDE	Coupler LLC	51b35391-7672-c02f-e063-6294a90af54e	2026-05-13	Warnings, Adverse reactions	Name fallback brand name: Glipizide generic name: GLIPIZIDE
Glipizide	GLIPIZIDE	Bryant Ranch Prepack	2aa01a7e-a703-426f-9cd3-70b88d0a8e7f	2026-05-13	Warnings, Adverse reactions	Name fallback brand name: Glipizide generic name: GLIPIZIDE
Glipizide	GLIPIZIDE	Cardinal Health 107, LLC	bf1f5a5d-79b0-4fc5-96f2-bd5119b56e2a	2026-05-08	Warnings, Adverse reactions	Name fallback brand name: Glipizide generic name: GLIPIZIDE
Glipizide	GLIPIZIDE	Preferred Pharmaceuticals Inc..	02857195-33e9-4c1f-9e5f-7cc62f283649	2026-05-07	Warnings, Adverse reactions	Name fallback brand name: Glipizide generic name: GLIPIZIDE
Glipizide	GLIPIZIDE	Preferred Pharmaceuticals Inc.	548c1f50-dbf0-49cc-b58b-fcc5937affa8	2026-05-07	Warnings, Adverse reactions	Name fallback brand name: Glipizide generic name: GLIPIZIDE
Glipizide	GLIPIZIDE	Preferred Pharmaceuticals Inc.	4632b4ec-d2f1-40cc-8ef4-256413d8dbec	2026-05-06	Warnings, Adverse reactions	Name fallback brand name: Glipizide generic name: GLIPIZIDE
Glipizide	GLIPIZIDE	Preferred Pharmaceuticals, Inc.	097424ef-612f-4bc2-809a-e5bb8eeae244	2026-05-06	Warnings, Adverse reactions	Name fallback brand name: Glipizide generic name: GLIPIZIDE
Glipizide	GLIPIZIDE	Preferred Pharmaceuticals Inc.	65ddb8b3-19d4-482f-8aec-49dc167a4c40	2026-05-06	Warnings, Adverse reactions	Name fallback brand name: Glipizide generic name: GLIPIZIDE
Glipizide	GLIPIZIDE	Bryant Ranch Prepack	ceb86ebb-d00a-4261-90ad-8751e799d93c	2026-04-20	Warnings, Adverse reactions	Name fallback brand name: Glipizide generic name: GLIPIZIDE
Glipizide	GLIPIZIDE	A-S Medication Solutions	99af53db-e102-427a-a5a2-be1e69b3152d	2026-04-16	Warnings, Adverse reactions	Name fallback brand name: Glipizide generic name: GLIPIZIDE
Glipizide	GLIPIZIDE	Bryant Ranch Prepack	4afa67b2-7f86-4189-93a5-6a605f74540d	2026-04-09	Warnings, Adverse reactions	Name fallback brand name: Glipizide generic name: GLIPIZIDE
Glipizide	GLIPIZIDE	A-S Medication Solutions	a34b58ac-42b2-4a19-a28b-cb3144ea55cd	2026-03-26	Warnings, Adverse reactions	Name fallback brand name: Glipizide generic name: GLIPIZIDE
Glipizide	GLIPIZIDE	Major Pharmaceuticals	d3b5677c-2265-47c8-beeb-bf12106056ba	2026-03-13	Warnings, Adverse reactions	Name fallback brand name: Glipizide generic name: GLIPIZIDE
Glipizide	GLIPIZIDE	Advagen Pharma Limited	e954afb8-52eb-416a-8f1b-14b0fcb3bac2	2026-03-06	Warnings, Adverse reactions	Name fallback brand name: Glipizide generic name: GLIPIZIDE
Glipizide	GLIPIZIDE	Legacy Pharmaceutical Packaging, LLC	116ffc6a-735c-49e0-a9d5-69b6bc3e3706	2026-03-03	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.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 5 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
51655-105	GLIPIZIDE	GLIPIZIDE	Northwind Pharmaceuticals	ANDA	Current
57664-398	Glipizide	glipizide	Sun Pharmaceutical Industries, Inc.	ANDA	Current
57664-399	Glipizide	glipizide	Sun Pharmaceutical Industries, Inc.	ANDA	Current
61919-286	Glipizide	Glipizide	DIRECT RX	ANDA	Current
61919-286	Glipizide	Glipizide	DIRECT RX	ANDA	Current