Application 091182

Type: ANDA
Sponsor: KENTON

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	GLYCOPYRROLATE	GLYCOPYRROLATE	TABLET;ORAL	1MG	No	No
002	GLYCOPYRROLATE	GLYCOPYRROLATE	TABLET;ORAL	2MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A091182-001	GLYCOPYRROLATE	GLYCOPYRROLATE	1MG	TABLET / ORAL	AA		2014-02-03
A091182-002	GLYCOPYRROLATE	GLYCOPYRROLATE	2MG	TABLET / ORAL	AA		2014-02-03

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A091182-001	AA
A091182-002	AA

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 · 82 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
2026-02-19 14:30 UTC	2026-02	A091182-001	GLYCOPYRROLATE	1MG	TABLET / ORAL	AA	2014-02-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091182-002	GLYCOPYRROLATE	2MG	TABLET / ORAL	AA	2014-02-03	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091182-001	GLYCOPYRROLATE	1MG	TABLET / ORAL	AA	2014-02-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091182-002	GLYCOPYRROLATE	2MG	TABLET / ORAL	AA	2014-02-03	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091182-001	GLYCOPYRROLATE	1MG	TABLET / ORAL	AA	2014-02-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091182-002	GLYCOPYRROLATE	2MG	TABLET / ORAL	AA	2014-02-03	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091182-001	GLYCOPYRROLATE	1MG	TABLET / ORAL	AA	2014-02-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091182-002	GLYCOPYRROLATE	2MG	TABLET / ORAL	AA	2014-02-03	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091182-001	GLYCOPYRROLATE	1MG	TABLET / ORAL	AA	2014-02-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091182-002	GLYCOPYRROLATE	2MG	TABLET / ORAL	AA	2014-02-03	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091182-001	GLYCOPYRROLATE	1MG	TABLET / ORAL	AA	2014-02-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091182-002	GLYCOPYRROLATE	2MG	TABLET / ORAL	AA	2014-02-03	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091182-001	GLYCOPYRROLATE	1MG	TABLET / ORAL	AA	2014-02-03	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091182-002	GLYCOPYRROLATE	2MG	TABLET / ORAL	AA	2014-02-03	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091182-001	GLYCOPYRROLATE	1MG	TABLET / ORAL	AA	2014-02-03	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091182-002	GLYCOPYRROLATE	2MG	TABLET / ORAL	AA	2014-02-03	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091182-001	GLYCOPYRROLATE	1MG	TABLET / ORAL	AA	2014-02-03	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091182-002	GLYCOPYRROLATE	2MG	TABLET / ORAL	AA	2014-02-03	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091182-001	GLYCOPYRROLATE	1MG	TABLET / ORAL	AA	2014-02-03	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091182-002	GLYCOPYRROLATE	2MG	TABLET / ORAL	AA	2014-02-03	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091182-001	GLYCOPYRROLATE	1MG	TABLET / ORAL	AA	2014-02-03	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091182-002	GLYCOPYRROLATE	2MG	TABLET / ORAL	AA	2014-02-03	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091182-001	GLYCOPYRROLATE	1MG	TABLET / ORAL	AA	2014-02-03	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091182-002	GLYCOPYRROLATE	2MG	TABLET / ORAL	AA	2014-02-03	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091182-001	GLYCOPYRROLATE	1MG	TABLET / ORAL	AA	2014-02-03	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091182-002	GLYCOPYRROLATE	2MG	TABLET / ORAL	AA	2014-02-03	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091182-001	GLYCOPYRROLATE	1MG	TABLET / ORAL	AA	2014-02-03	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A091182-002	GLYCOPYRROLATE	2MG	TABLET / ORAL	AA	2014-02-03	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091182-001	GLYCOPYRROLATE	1MG	TABLET / ORAL	AA	2014-02-03	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091182-002	GLYCOPYRROLATE	2MG	TABLET / ORAL	AA	2014-02-03	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091182-001	GLYCOPYRROLATE	1MG	TABLET / ORAL	AA	2014-02-03	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A091182-002	GLYCOPYRROLATE	2MG	TABLET / ORAL	AA	2014-02-03	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091182-001	GLYCOPYRROLATE	1MG	TABLET / ORAL	AA	2014-02-03	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A091182-002	GLYCOPYRROLATE	2MG	TABLET / ORAL	AA	2014-02-03	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A091182-001	GLYCOPYRROLATE	1MG	TABLET / ORAL	AA	2014-02-03	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A091182-002	GLYCOPYRROLATE	2MG	TABLET / ORAL	AA	2014-02-03	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A091182-001	GLYCOPYRROLATE	1MG	TABLET / ORAL	AA	2014-02-03	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A091182-002	GLYCOPYRROLATE	2MG	TABLET / ORAL	AA	2014-02-03	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A091182-001	GLYCOPYRROLATE	1MG	TABLET / ORAL	AA	2014-02-03	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A091182-002	GLYCOPYRROLATE	2MG	TABLET / ORAL	AA	2014-02-03	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A091182-001	AA	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091182-002	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091182-001	AA	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091182-002	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091182-001	AA	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091182-002	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091182-001	AA	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091182-002	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091182-001	AA	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091182-002	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091182-001	AA	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091182-002	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091182-001	AA	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091182-002	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091182-001	AA	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091182-002	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091182-001	AA	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091182-002	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091182-001	AA	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091182-002	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091182-001	AA	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091182-002	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091182-001	AA	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091182-002	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091182-001	AA	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091182-002	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091182-001	AA	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A091182-002	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091182-001	AA	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091182-002	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091182-001	AA	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A091182-002	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091182-001	AA	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A091182-002	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A091182-001	AA	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A091182-002	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A091182-001	AA	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A091182-002	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A091182-001	AA	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A091182-002	AA	1	`782e0a99824c…`

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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
GLYCOPYRROLATE	GLYCOPYRROLATE	Golden State Medical Supply, Inc.	ec15e70c-8473-469a-9f07-ea668783fa07	2026-05-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091182 application number: ANDA091182 ndc (product): 60429-665 ndc (product): 60429-666
Glycopyrrolate	GLYCOPYRROLATE	Florida Pharmaceutical Products, LLC	2cda1ed5-10bb-4651-acbf-be44ad709665	2026-02-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091182 application number: ANDA091182
GLYCOPYRROLATE	GLYCOPYRROLATE	Bryant Ranch Prepack	4c733750-45fe-4876-8e4f-c61c52470405	2023-06-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091182 application number: ANDA091182 ndc (product): 71335-1225
GLYCOPYRROLATE	GLYCOPYRROLATE	Quinn Pharmaceuticals	e1ded8e0-c05b-4bf4-a129-57d1726af6ed	2022-12-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091182 application number: ANDA091182 ndc (product): 69076-475 ndc (product): 69076-476

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 31 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
60429-665	GLYCOPYRROLATE	GLYCOPYRROLATE	Golden State Medical Supply, Inc.	ANDA	Current
60429-665	GLYCOPYRROLATE	GLYCOPYRROLATE	Golden State Medical Supply	ANDA	Current
60429-665	GLYCOPYRROLATE	GLYCOPYRROLATE	Golden State Medical Supply, Inc.	ANDA	Current
60429-665	GLYCOPYRROLATE	GLYCOPYRROLATE	Golden State Medical Supply, Inc.	ANDA	Current
60429-665	GLYCOPYRROLATE	GLYCOPYRROLATE	Golden State Medical Supply, Inc.	ANDA	Current
60429-665	GLYCOPYRROLATE	GLYCOPYRROLATE	Golden State Medical Supply, Inc.	ANDA	Current
60429-666	GLYCOPYRROLATE	GLYCOPYRROLATE	Golden State Medical Supply, Inc.	ANDA	Current
60429-666	GLYCOPYRROLATE	GLYCOPYRROLATE	Golden State Medical Supply	ANDA	Current
60429-666	GLYCOPYRROLATE	GLYCOPYRROLATE	Golden State Medical Supply, Inc.	ANDA	Current
60429-666	GLYCOPYRROLATE	GLYCOPYRROLATE	Golden State Medical Supply, Inc.	ANDA	Current
60429-666	GLYCOPYRROLATE	GLYCOPYRROLATE	Golden State Medical Supply, Inc.	ANDA	Current
60429-666	GLYCOPYRROLATE	GLYCOPYRROLATE	Golden State Medical Supply, Inc.	ANDA	Current
60763-475	Glycopyrrolate	Glycopyrrolate	Stason Pharmaceuticals, Inc.	ANDA	Current
60763-476	Glycopyrrolate	Glycopyrrolate	Stason Pharmaceuticals, Inc.	ANDA	Current
69076-475	GLYCOPYRROLATE	GLYCOPYRROLATE	Quinn Pharmaceuticals, LLC	ANDA	Current
69076-475	GLYCOPYRROLATE	GLYCOPYRROLATE	Quinn Pharmaceuticals, LLC	ANDA	Current
69076-475	GLYCOPYRROLATE	GLYCOPYRROLATE	Quinn Pharmaceuticals	ANDA	Current
69076-475	GLYCOPYRROLATE	GLYCOPYRROLATE	Quinn Pharmaceuticals	ANDA	Current
69076-475	GLYCOPYRROLATE	GLYCOPYRROLATE	Quinn Pharmaceuticals	ANDA	Current
69076-475	GLYCOPYRROLATE	GLYCOPYRROLATE	Quinn Pharmaceuticals	ANDA	Current
69076-476	GLYCOPYRROLATE	GLYCOPYRROLATE	Quinn Pharmaceuticals, LLC	ANDA	Current
69076-476	GLYCOPYRROLATE	GLYCOPYRROLATE	Quinn Pharmaceuticals, LLC	ANDA	Current
69076-476	GLYCOPYRROLATE	GLYCOPYRROLATE	Quinn Pharmaceuticals	ANDA	Current
69076-476	GLYCOPYRROLATE	GLYCOPYRROLATE	Quinn Pharmaceuticals	ANDA	Current
69076-476	GLYCOPYRROLATE	GLYCOPYRROLATE	Quinn Pharmaceuticals	ANDA	Current
69076-476	GLYCOPYRROLATE	GLYCOPYRROLATE	Quinn Pharmaceuticals	ANDA	Current
70518-3152	GLYCOPYRROLATE	GLYCOPYRROLATE	REMEDYREPACK INC.	ANDA	Current
70518-3152	GLYCOPYRROLATE	GLYCOPYRROLATE	REMEDYREPACK INC.	ANDA	Current
71335-1225	GLYCOPYRROLATE	GLYCOPYRROLATE	Bryant Ranch Prepack	ANDA	Current
71335-1225	GLYCOPYRROLATE	GLYCOPYRROLATE	Bryant Ranch Prepack	ANDA	Current
71335-1225	GLYCOPYRROLATE	GLYCOPYRROLATE	Bryant Ranch Prepack	ANDA	Current