Application 020329

Type: NDA
Sponsor: PFIZER

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	GLUCOTROL XL	GLIPIZIDE	TABLET, EXTENDED RELEASE;ORAL	5MG	Yes	No
002	GLUCOTROL XL	GLIPIZIDE	TABLET, EXTENDED RELEASE;ORAL	10MG	Yes	Yes
003	GLUCOTROL XL	GLIPIZIDE	TABLET, EXTENDED RELEASE;ORAL	2.5MG	Yes	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	RLD / RS	Approval date
N020329-001	GLUCOTROL XL	GLIPIZIDE	5MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	1994-04-26
N020329-002	GLUCOTROL XL	GLIPIZIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	1994-04-26
N020329-003	GLUCOTROL XL	GLIPIZIDE	2.5MG	TABLET, EXTENDED RELEASE / ORAL		RLD	1999-08-10

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
N020329-001	AB
N020329-002	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	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N020329-001	GLUCOTROL XL	5MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	1994-04-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020329-002	GLUCOTROL XL	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	1994-04-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020329-003	GLUCOTROL XL	2.5MG	TABLET, EXTENDED RELEASE / ORAL		RLD	1999-08-10	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N020329-001	GLUCOTROL XL	5MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	1994-04-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020329-002	GLUCOTROL XL	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	1994-04-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020329-003	GLUCOTROL XL	2.5MG	TABLET, EXTENDED RELEASE / ORAL		RLD	1999-08-10	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020329-001	GLUCOTROL XL	5MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	1994-04-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020329-002	GLUCOTROL XL	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	1994-04-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020329-003	GLUCOTROL XL	2.5MG	TABLET, EXTENDED RELEASE / ORAL		RLD	1999-08-10	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020329-001	GLUCOTROL XL	5MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	1994-04-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020329-002	GLUCOTROL XL	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	1994-04-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020329-003	GLUCOTROL XL	2.5MG	TABLET, EXTENDED RELEASE / ORAL		RLD	1999-08-10	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020329-001	GLUCOTROL XL	5MG	TABLET, EXTENDED RELEASE / ORAL		RLD	1994-04-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020329-002	GLUCOTROL XL	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	1994-04-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020329-003	GLUCOTROL XL	2.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	1999-08-10	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020329-001	GLUCOTROL XL	5MG	TABLET, EXTENDED RELEASE / ORAL		RLD	1994-04-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020329-002	GLUCOTROL XL	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	1994-04-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020329-003	GLUCOTROL XL	2.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	1999-08-10	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020329-001	GLUCOTROL XL	5MG	TABLET, EXTENDED RELEASE / ORAL		RLD	1994-04-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020329-002	GLUCOTROL XL	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	1994-04-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020329-003	GLUCOTROL XL	2.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	1999-08-10	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020329-001	GLUCOTROL XL	5MG	TABLET, EXTENDED RELEASE / ORAL		RLD	1994-04-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020329-002	GLUCOTROL XL	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	1994-04-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020329-003	GLUCOTROL XL	2.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	1999-08-10	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020329-001	GLUCOTROL XL	5MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	1994-04-26	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020329-002	GLUCOTROL XL	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	1994-04-26	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020329-003	GLUCOTROL XL	2.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	1999-08-10	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020329-001	GLUCOTROL XL	5MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	1994-04-26	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020329-002	GLUCOTROL XL	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	1994-04-26	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020329-003	GLUCOTROL XL	2.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	1999-08-10	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020329-001	GLUCOTROL XL	5MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	1994-04-26	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020329-002	GLUCOTROL XL	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	1994-04-26	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020329-003	GLUCOTROL XL	2.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	1999-08-10	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020329-001	GLUCOTROL XL	5MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	1994-04-26	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020329-002	GLUCOTROL XL	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	1994-04-26	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020329-003	GLUCOTROL XL	2.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	1999-08-10	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020329-001	GLUCOTROL XL	5MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	1994-04-26	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020329-002	GLUCOTROL XL	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	1994-04-26	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020329-003	GLUCOTROL XL	2.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	1999-08-10	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020329-001	GLUCOTROL XL	5MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	1994-04-26	`1e350fbaab3a…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 117 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	N020329-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020329-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N020329-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020329-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020329-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020329-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020329-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020329-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020329-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020329-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020329-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020329-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020329-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020329-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020329-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020329-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020329-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020329-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020329-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020329-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020329-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020329-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020329-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020329-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020329-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020329-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020329-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020329-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020329-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020329-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020329-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020329-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020329-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020329-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020329-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N020329-002	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N020329-003	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020329-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020329-002	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020329-003	AB	1	`5c6f7cd8ea54…`

Observed Orange Book patent history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Submission date	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N020329-001	RE44459	2019-03-26	U-1431	2013-09-20	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020329-002	RE44459	2019-03-26	U-1431	2013-09-20	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020329-003	RE44459	2019-03-26	U-1431	2013-09-20	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	N020329-001	RE44459	2019-03-26	U-1431	2013-09-20	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N020329-002	RE44459	2019-03-26	U-1431	2013-09-20	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N020329-003	RE44459	2019-03-26	U-1431	2013-09-20	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N020329-001	RE44459	2019-03-26	U-1431	2013-09-20	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N020329-002	RE44459	2019-03-26	U-1431	2013-09-20	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N020329-003	RE44459	2019-03-26	U-1431	2013-09-20	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N020329-001	RE44459	2019-03-26	U-1431	2013-09-20	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N020329-002	RE44459	2019-03-26	U-1431	2013-09-20	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N020329-003	RE44459	2019-03-26	U-1431	2013-09-20	`ea99ee380514…`

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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Glucotrol XL	GLIPIZIDE	Roerig	eed99b60-d043-4249-9b2a-f05e46fb588d	2026-07-21	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020329 application number: NDA020329 ndc (product): 0049-0174 ndc (product): 0049-0178 ndc (product): 0049-0170

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 27 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0049-0170	Glucotrol	glipizide	Roerig	NDA	Current
0049-0170	Glucotrol	glipizide	Roerig	NDA	Current
0049-0170	Glucotrol	glipizide	Roerig	NDA	Current
0049-0174	Glucotrol	glipizide	Roerig	NDA	Current
0049-0174	Glucotrol	glipizide	Roerig	NDA	Current
0049-0174	Glucotrol	glipizide	Roerig	NDA	Current
0049-0178	Glucotrol	glipizide	Roerig	NDA	Current
0049-0178	Glucotrol	glipizide	Roerig	NDA	Current
0049-0178	Glucotrol	glipizide	Roerig	NDA	Current
51655-361	Glipizide	glipizide	Northwind Pharmaceuticals	NDA AUTHORIZED GENERIC	Current
51655-361	Glipizide	glipizide	Northwind Pharmaceuticals	NDA AUTHORIZED GENERIC	Current
53808-0408	Glipizide XL	glipizide	State of Florida DOH Central Pharmacy	NDA	Current
53808-0409	Glipizide XL	glipizide	State of Florida DOH Central Pharmacy	NDA	Current
53808-0942	Glipizide	glipizide	State of Florida DOH Central Pharmacy	NDA AUTHORIZED GENERIC	Current
55154-0539	Glipizide	glipizide	Cardinal Health	NDA	Current
59762-0540	Glipizide	glipizide	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
59762-0540	Glipizide	glipizide	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
59762-0540	Glipizide	glipizide	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
59762-0541	Glipizide	glipizide	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
59762-0541	Glipizide	glipizide	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
59762-0541	Glipizide	glipizide	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
59762-0542	Glipizide	glipizide	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
59762-0542	Glipizide	glipizide	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
59762-0542	Glipizide	glipizide	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
70934-391	Glipizide	glipizide	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	NDA AUTHORIZED GENERIC	Current
70934-391	Glipizide	glipizide	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	NDA AUTHORIZED GENERIC	Current
70934-391	Glipizide	glipizide	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	NDA AUTHORIZED GENERIC	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
68587	SUPPL	2021-09-13
68584	SUPPL	2021-09-13
55200	SUPPL	2018-08-17
55170	SUPPL	2018-08-13
49569	SUPPL	2017-08-29
49446	SUPPL	2017-08-17
12452	SUPPL	2015-10-08
2337	SUPPL	2015-10-06
12451	SUPPL	2013-10-22
24786	SUPPL	2013-10-16
2336	SUPPL	2011-02-09
12450	SUPPL	2011-02-07
34507	SUPPL	2009-09-17
12449	SUPPL	2008-11-07
2335	SUPPL	2008-10-29
41281	SUPPL	2007-07-09
41280	SUPPL	2006-10-25
24785	SUPPL	2003-09-29
24784	SUPPL	2002-04-01
12448	SUPPL	2002-04-01