Application 090195

Type: ANDA
Sponsor: LEADING PHARMA LLC

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 42.

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
A090195-001	GLYCOPYRROLATE	GLYCOPYRROLATE	1MG	TABLET / ORAL	AA		2012-09-21
A090195-002	GLYCOPYRROLATE	GLYCOPYRROLATE	2MG	TABLET / ORAL	AA		2012-09-21

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A090195-001	AA
A090195-002	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 · 84 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	A090195-001	GLYCOPYRROLATE	1MG	TABLET / ORAL	AA	2012-09-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090195-002	GLYCOPYRROLATE	2MG	TABLET / ORAL	AA	2012-09-21	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A090195-001	GLYCOPYRROLATE	1MG	TABLET / ORAL	AA	2012-09-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090195-002	GLYCOPYRROLATE	2MG	TABLET / ORAL	AA	2012-09-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090195-001	GLYCOPYRROLATE	1MG	TABLET / ORAL	AA	2012-09-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090195-002	GLYCOPYRROLATE	2MG	TABLET / ORAL	AA	2012-09-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090195-001	GLYCOPYRROLATE	1MG	TABLET / ORAL	AA	2012-09-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090195-002	GLYCOPYRROLATE	2MG	TABLET / ORAL	AA	2012-09-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090195-001	GLYCOPYRROLATE	1MG	TABLET / ORAL	AA	2012-09-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090195-002	GLYCOPYRROLATE	2MG	TABLET / ORAL	AA	2012-09-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090195-001	GLYCOPYRROLATE	1MG	TABLET / ORAL	AA	2012-09-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090195-002	GLYCOPYRROLATE	2MG	TABLET / ORAL	AA	2012-09-21	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090195-001	GLYCOPYRROLATE	1MG	TABLET / ORAL	AA	2012-09-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090195-002	GLYCOPYRROLATE	2MG	TABLET / ORAL	AA	2012-09-21	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090195-001	GLYCOPYRROLATE	1MG	TABLET / ORAL	AA	2012-09-21	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090195-002	GLYCOPYRROLATE	2MG	TABLET / ORAL	AA	2012-09-21	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090195-001	GLYCOPYRROLATE	1MG	TABLET / ORAL	AA	2012-09-21	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090195-002	GLYCOPYRROLATE	2MG	TABLET / ORAL	AA	2012-09-21	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090195-001	GLYCOPYRROLATE	1MG	TABLET / ORAL	AA	2012-09-21	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090195-002	GLYCOPYRROLATE	2MG	TABLET / ORAL	AA	2012-09-21	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090195-001	GLYCOPYRROLATE	1MG	TABLET / ORAL	AA	2012-09-21	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090195-002	GLYCOPYRROLATE	2MG	TABLET / ORAL	AA	2012-09-21	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090195-001	GLYCOPYRROLATE	1MG	TABLET / ORAL	AA	2012-09-21	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090195-002	GLYCOPYRROLATE	2MG	TABLET / ORAL	AA	2012-09-21	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090195-001	GLYCOPYRROLATE	1MG	TABLET / ORAL	AA	2012-09-21	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090195-002	GLYCOPYRROLATE	2MG	TABLET / ORAL	AA	2012-09-21	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090195-001	GLYCOPYRROLATE	1MG	TABLET / ORAL	AA	2012-09-21	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090195-002	GLYCOPYRROLATE	2MG	TABLET / ORAL	AA	2012-09-21	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090195-001	GLYCOPYRROLATE	1MG	TABLET / ORAL	AA	2012-09-21	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A090195-002	GLYCOPYRROLATE	2MG	TABLET / ORAL	AA	2012-09-21	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090195-001	GLYCOPYRROLATE	1MG	TABLET / ORAL	AA	2012-09-21	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090195-002	GLYCOPYRROLATE	2MG	TABLET / ORAL	AA	2012-09-21	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090195-001	GLYCOPYRROLATE	1MG	TABLET / ORAL	AA	2012-09-21	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A090195-002	GLYCOPYRROLATE	2MG	TABLET / ORAL	AA	2012-09-21	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090195-001	GLYCOPYRROLATE	1MG	TABLET / ORAL	AA	2012-09-21	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A090195-002	GLYCOPYRROLATE	2MG	TABLET / ORAL	AA	2012-09-21	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090195-001	GLYCOPYRROLATE	1MG	TABLET / ORAL	AA	2012-09-21	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A090195-002	GLYCOPYRROLATE	2MG	TABLET / ORAL	AA	2012-09-21	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090195-001	GLYCOPYRROLATE	1MG	TABLET / ORAL	AA	2012-09-21	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A090195-002	GLYCOPYRROLATE	2MG	TABLET / ORAL	AA	2012-09-21	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 84 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	A090195-001	AA	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090195-002	AA	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A090195-001	AA	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090195-002	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090195-001	AA	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090195-002	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090195-001	AA	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090195-002	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090195-001	AA	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090195-002	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090195-001	AA	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090195-002	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090195-001	AA	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090195-002	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090195-001	AA	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090195-002	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090195-001	AA	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090195-002	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090195-001	AA	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090195-002	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090195-001	AA	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090195-002	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090195-001	AA	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090195-002	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090195-001	AA	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090195-002	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090195-001	AA	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090195-002	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090195-001	AA	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A090195-002	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090195-001	AA	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090195-002	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090195-001	AA	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A090195-002	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090195-001	AA	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A090195-002	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090195-001	AA	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A090195-002	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090195-001	AA	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A090195-002	AA	1	`bb7c543d1eb4…`

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Glycopyrrolate	GLYCOPYRROLATE	Leading Pharma, LLC	498bce66-6072-4212-8413-ff9888c58f9c	2025-04-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090195 application number: ANDA090195 ndc (product): 69315-139 ndc (product): 69315-140
Glycopyrrolate	GLYCOPYRROLATE	Bryant Ranch Prepack	5ee5f433-fd99-4c8d-8263-b8956d489620	2024-12-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090195 application number: ANDA090195

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 18 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0904-6521	Glycopyrrolate	Glycopyrrolate	Major Pharmaceuticals	ANDA	Current
42291-303	Glycopyrrolate	Glycopyrrolate	AvKARE, Inc.	ANDA	Current
42291-303	Glycopyrrolate	Glycopyrrolate	AvKARE	ANDA	Current
42291-304	Glycopyrrolate	Glycopyrrolate	AvKARE, Inc.	ANDA	Current
42291-304	Glycopyrrolate	Glycopyrrolate	AvKARE	ANDA	Current
64125-139	Glycopyrrolate	Glycopyrrolate	Excellium Pharmaceutical, Inc.	ANDA	Current
64125-140	Glycopyrrolate	Glycopyrrolate	Excellium Pharmaceutical, Inc.	ANDA	Current
69315-139	Glycopyrrolate	Glycopyrrolate	Leading Pharma, LLC	ANDA	Current
69315-139	Glycopyrrolate	Glycopyrrolate	Leading Pharma, LLC	ANDA	Current
69315-139	Glycopyrrolate	Glycopyrrolate	Leading Pharma, LLC	ANDA	Current
69315-139	Glycopyrrolate	Glycopyrrolate	Leading Pharma, LLC	ANDA	Current
69315-140	Glycopyrrolate	Glycopyrrolate	Leading Pharma, LLC	ANDA	Current
69315-140	Glycopyrrolate	Glycopyrrolate	Leading Pharma, LLC	ANDA	Current
69315-140	Glycopyrrolate	Glycopyrrolate	Leading Pharma, LLC	ANDA	Current
69315-140	Glycopyrrolate	Glycopyrrolate	Leading Pharma, LLC	ANDA	Current
71335-0020	Glycopyrrolate	Glycopyrrolate	Bryant Ranch Prepack	ANDA	Current
71335-0020	Glycopyrrolate	Glycopyrrolate	Bryant Ranch Prepack	ANDA	Current
71335-0020	Glycopyrrolate	Glycopyrrolate	Bryant Ranch Prepack	ANDA	Current