Application 091522

Type: ANDA
Sponsor: NEXGEN PHARMA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	GLYCOPYRROLATE	GLYCOPYRROLATE	TABLET;ORAL	1.5MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A091522-001	GLYCOPYRROLATE	GLYCOPYRROLATE	1.5MG	TABLET / ORAL		RS	2012-03-12

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 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A091522-001	GLYCOPYRROLATE	1.5MG	TABLET / ORAL	RS	2012-03-12	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A091522-001	GLYCOPYRROLATE	1.5MG	TABLET / ORAL	RS	2012-03-12	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091522-001	GLYCOPYRROLATE	1.5MG	TABLET / ORAL	RS	2012-03-12	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091522-001	GLYCOPYRROLATE	1.5MG	TABLET / ORAL	RS	2012-03-12	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091522-001	GLYCOPYRROLATE	1.5MG	TABLET / ORAL	RS	2012-03-12	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091522-001	GLYCOPYRROLATE	1.5MG	TABLET / ORAL	RS	2012-03-12	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091522-001	GLYCOPYRROLATE	1.5MG	TABLET / ORAL	RS	2012-03-12	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091522-001	GLYCOPYRROLATE	1.5MG	TABLET / ORAL	RS	2012-03-12	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091522-001	GLYCOPYRROLATE	1.5MG	TABLET / ORAL	RS	2012-03-12	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091522-001	GLYCOPYRROLATE	1.5MG	TABLET / ORAL	RS	2012-03-12	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091522-001	GLYCOPYRROLATE	1.5MG	TABLET / ORAL	RS	2012-03-12	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091522-001	GLYCOPYRROLATE	1.5MG	TABLET / ORAL	RS	2012-03-12	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091522-001	GLYCOPYRROLATE	1.5MG	TABLET / ORAL		2012-03-12	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091522-001	GLYCOPYRROLATE	1.5MG	TABLET / ORAL		2012-03-12	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091522-001	GLYCOPYRROLATE	1.5MG	TABLET / ORAL		2012-03-12	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091522-001	GLYCOPYRROLATE	1.5MG	TABLET / ORAL		2012-03-12	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091522-001	GLYCOPYRROLATE	1.5MG	TABLET / ORAL		2012-03-12	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091522-001	GLYCOPYRROLATE	1.5MG	TABLET / ORAL		2012-03-12	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A091522-001	GLYCOPYRROLATE	1.5MG	TABLET / ORAL		2012-03-12	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A091522-001	GLYCOPYRROLATE	1.5MG	TABLET / ORAL		2012-03-12	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A091522-001	GLYCOPYRROLATE	1.5MG	TABLET / ORAL		2012-03-12	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A091522-001	GLYCOPYRROLATE	1.5MG	TABLET / ORAL		2012-03-12	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A091522-001	GLYCOPYRROLATE	1.5MG	TABLET / ORAL		2012-03-12	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A091522-001	GLYCOPYRROLATE	1.5MG	TABLET / ORAL		2012-03-12	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A091522-001	GLYCOPYRROLATE	1.5MG	TABLET / ORAL		2012-03-12	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A091522-001	GLYCOPYRROLATE	1.5MG	TABLET / ORAL		2012-03-12	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A091522-001	GLYCOPYRROLATE	1.5MG	TABLET / ORAL		2012-03-12	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A091522-001	GLYCOPYRROLATE	1.5MG	TABLET / ORAL		2012-03-12	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A091522-001	GLYCOPYRROLATE	1.5MG	TABLET / ORAL		2012-03-12	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A091522-001	GLYCOPYRROLATE	1.5MG	TABLET / ORAL		2012-03-12	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A091522-001	GLYCOPYRROLATE	1.5MG	TABLET / ORAL		2012-03-12	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A091522-001	GLYCOPYRROLATE	1.5MG	TABLET / ORAL		2012-03-12	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A091522-001	GLYCOPYRROLATE	1.5MG	TABLET / ORAL		2012-03-12	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A091522-001	GLYCOPYRROLATE	1.5MG	TABLET / ORAL		2012-03-12	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A091522-001	GLYCOPYRROLATE	1.5MG	TABLET / ORAL		2012-03-12	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A091522-001	GLYCOPYRROLATE	1.5MG	TABLET / ORAL		2012-03-12	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A091522-001	GLYCOPYRROLATE	1.5MG	TABLET / ORAL		2012-03-12	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A091522-001	GLYCOPYRROLATE	1.5MG	TABLET / ORAL		2012-03-12	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A091522-001	GLYCOPYRROLATE	1.5MG	TABLET / ORAL		2012-03-12	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A091522-001	GLYCOPYRROLATE	1.5MG	TABLET / ORAL		2012-03-12	`e64feba35796…`

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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Glycate	GLYCOPYRROLATE	Intra-Sana Laboratories	830ba1be-bef3-417c-a915-964cc6005b92	2026-01-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091522 application number: ANDA091522 ndc (product): 80056-160
GLYCOPYRROLATE	GLYCOPYRROLATE	FH2 Pharma LLC	18ca98ed-522d-470f-bb22-908bbd7d489a	2023-12-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091522 application number: ANDA091522 ndc (product): 72887-160
Glycopyrrolate	GLYCOPYRROLATE	LGM PHARMA SOLUTIONS, LLC	392a969d-1e14-4ad8-835c-a47be4983067	2023-04-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091522 application number: ANDA091522 ndc (product): 79739-7097

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 13 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0722-7097	Glycopyrrolate	Glycopyrrolate	Nexgen Pharma, Inc.	ANDA	Current
0722-7097	Glycopyrrolate	Glycopyrrolate	Nexgen Pharma, Inc.	ANDA	Current
15370-160	GLYCATE	GLYCOPYRROLATE	Carwin Pharmaceutical Associates, LLC	ANDA	Current
15370-160	GLYCATE	GLYCOPYRROLATE	Carwin Pharmaceutical Associates, LLC	ANDA	Current
59547-210	Glycate	Glycopyrrolate	Nuro Pharma, Inc.	ANDA	Current
69067-050	Glycopyrrolate	GLYCOPYRROLATE	Foxland Pharmaceuticals, Inc.	ANDA	Current
69067-050	Glycopyrrolate	GLYCOPYRROLATE	Foxland Pharmaceuticals, Inc.	ANDA	Current
69067-050	Glycopyrrolate	GLYCOPYRROLATE	Foxland Pharmaceuticals, Inc.	ANDA	Current
72887-160	GLYCOPYRROLATE	GLYCOPYRROLATE	FH2 Pharma LLC	ANDA	Current
72887-160	GLYCOPYRROLATE	GLYCOPYRROLATE	FH2 Pharma LLC	ANDA	Current
79739-7097	Glycopyrrolate	Glycopyrrolate	LGM Pharma Solutions, LLC	ANDA	Current
80056-160	Glycate	Glycopyrrolate	Intra-Sana Laboratories	ANDA	Current
80056-160	Glycopyrrolate	Glycopyrrolate	Intra-Sana Laboratories	ANDA	Current