Application 214735

Type: ANDA
Sponsor: GRANULES

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	GLYCOPYRROLATE	GLYCOPYRROLATE	SOLUTION;ORAL	1MG/5ML	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 45.

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
A214735-001	GLYCOPYRROLATE	GLYCOPYRROLATE	1MG/5ML	SOLUTION / ORAL	AA		2024-08-19

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A214735-001	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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-11-14 07:37:17	2026-10	A214735-001	GLYCOPYRROLATE	1MG/5ML	SOLUTION / ORAL	AA	2024-08-19	`d4dbc9d85df4…`
2026-10-15 13:18:30	2026-09	A214735-001	GLYCOPYRROLATE	1MG/5ML	SOLUTION / ORAL	AA	2024-08-19	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A214735-001	GLYCOPYRROLATE	1MG/5ML	SOLUTION / ORAL	AA	2024-08-19	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A214735-001	GLYCOPYRROLATE	1MG/5ML	SOLUTION / ORAL	AA	2024-08-19	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A214735-001	GLYCOPYRROLATE	1MG/5ML	SOLUTION / ORAL	AA	2024-08-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214735-001	GLYCOPYRROLATE	1MG/5ML	SOLUTION / ORAL	AA	2024-08-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A214735-001	GLYCOPYRROLATE	1MG/5ML	SOLUTION / ORAL	AA	2024-08-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214735-001	GLYCOPYRROLATE	1MG/5ML	SOLUTION / ORAL	AA	2024-08-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214735-001	GLYCOPYRROLATE	1MG/5ML	SOLUTION / ORAL	AA	2024-08-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214735-001	GLYCOPYRROLATE	1MG/5ML	SOLUTION / ORAL	AA	2024-08-19	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214735-001	GLYCOPYRROLATE	1MG/5ML	SOLUTION / ORAL	AA	2024-08-19	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214735-001	GLYCOPYRROLATE	1MG/5ML	SOLUTION / ORAL	AA	2024-08-19	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214735-001	GLYCOPYRROLATE	1MG/5ML	SOLUTION / ORAL	AA	2024-08-19	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A214735-001	GLYCOPYRROLATE	1MG/5ML	SOLUTION / ORAL	AA	2024-08-19	`d06236e962d9…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A214735-001	GLYCOPYRROLATE	1MG/5ML	SOLUTION / ORAL	AA	2024-08-19	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-11-14 07:37:17	2026-10	A214735-001	AA	1	`d4dbc9d85df4…`
2026-10-15 13:18:30	2026-09	A214735-001	AA	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A214735-001	AA	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A214735-001	AA	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A214735-001	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214735-001	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A214735-001	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214735-001	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214735-001	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214735-001	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214735-001	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214735-001	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214735-001	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A214735-001	AA	1	`d06236e962d9…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A214735-001	AA	1	`a50c72e98297…`

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 5 of 6 · 105 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Glycopyrrolate	GLYCOPYRROLATE	Medical Purchasing Solutions, LLC	9c9666bf-841b-03fa-e053-2a95a90abb48	2023-05-11	Warnings, Adverse reactions	Name fallback brand name: Glycopyrrolate generic name: GLYCOPYRROLATE
Glycopyrrolate	GLYCOPYRROLATE	Medical Purchasing Solutions, LLC	9e5113b7-1c0c-24bd-e053-2995a90ab94b	2023-05-09	Warnings, Adverse reactions	Name fallback brand name: Glycopyrrolate generic name: GLYCOPYRROLATE
Glycopyrrolate	GLYCOPYRROLATE	Medical Purchasing Solutions, LLC	bbf0abe2-8deb-19b2-e053-2a95a90a60a3	2023-05-08	Warnings, Adverse reactions	Name fallback brand name: Glycopyrrolate generic name: GLYCOPYRROLATE
Glycopyrrolate	GLYCOPYRROLATE	Medical Purchasing Solutions, LLC	b622f21f-fa37-1259-e053-2995a90aa796	2023-05-04	Warnings, Adverse reactions	Name fallback brand name: Glycopyrrolate generic name: GLYCOPYRROLATE
GLYCOPYRROLATE	GLYCOPYRROLATE	Medical Purchasing Solutions, LLC	a2a2a03f-21cc-5fec-e053-2995a90a84cb	2023-05-03	Warnings, Adverse reactions	Name fallback brand name: GLYCOPYRROLATE generic name: GLYCOPYRROLATE
Glycopyrrolate	GLYCOPYRROLATE	LGM PHARMA SOLUTIONS, LLC	392a969d-1e14-4ad8-835c-a47be4983067	2023-04-27	Warnings, Adverse reactions	Name fallback brand name: Glycopyrrolate generic name: GLYCOPYRROLATE
Glycopyrrolate	GLYCOPYRROLATE	Medical Purchasing Solutions, LLC	e8bb95ed-09f1-fcf1-e053-2a95a90a93e5	2023-04-25	Warnings, Adverse reactions	Name fallback brand name: Glycopyrrolate generic name: GLYCOPYRROLATE
Glycopyrrolate	GLYCOPYRROLATE	Medical Purchasing Solutions, LLC	ea4c8be4-a1e9-5901-e053-2995a90a5e63	2023-04-24	Warnings, Adverse reactions	Name fallback brand name: Glycopyrrolate generic name: GLYCOPYRROLATE
Glycopyrrolate	GLYCOPYRROLATE	Civica, Inc.	3ac4f32f-f5ca-4a6d-9bc7-2672d478b3d4	2023-03-01	Warnings, Adverse reactions	Name fallback brand name: Glycopyrrolate generic name: GLYCOPYRROLATE
Glycopyrrolate	GLYCOPYRROLATE	Meitheal Pharmaceuticals Inc.	02f914a8-2356-4525-91ff-cf0c9e41ba23	2023-01-12	Warnings, Adverse reactions	Name fallback brand name: Glycopyrrolate generic name: GLYCOPYRROLATE
GLYCOPYRROLATE	GLYCOPYRROLATE	Quinn Pharmaceuticals	e1ded8e0-c05b-4bf4-a129-57d1726af6ed	2022-12-20	Warnings, Adverse reactions	Name fallback brand name: GLYCOPYRROLATE generic name: GLYCOPYRROLATE
Glycopyrrolate	GLYCOPYRROLATE	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	26cdd84d-ffa0-4e52-b359-4acef4bd8093	2022-11-10	Warnings, Adverse reactions	Name fallback brand name: Glycopyrrolate generic name: GLYCOPYRROLATE
Glycopyrrolate	GLYCOPYRROLATE	Camber Pharmaceuticals, Inc.	4741be85-3abb-4545-aba9-281f64d210ec	2022-07-13	Warnings, Adverse reactions	Name fallback brand name: Glycopyrrolate generic name: GLYCOPYRROLATE
GLYCOPYRROLATE	GLYCOPYRROLATE	Novadoz Pharmaceuticals LLC	98820c01-1853-45d8-9da5-875fcdf5f9ab	2022-06-14	Warnings, Adverse reactions	Name fallback brand name: GLYCOPYRROLATE generic name: GLYCOPYRROLATE
Glycopyrrolate	GLYCOPYRROLATE	Xiromed LLC	29618edf-39b0-022a-9875-9d865450d318	2022-04-12	Warnings, Adverse reactions	Name fallback brand name: Glycopyrrolate generic name: GLYCOPYRROLATE
Glycopyrrolate	GLYCOPYRROLATE	Xiromed, LLC	f777c813-3232-d744-8bcf-58e86fb929bd	2022-04-12	Warnings, Adverse reactions	Name fallback brand name: Glycopyrrolate generic name: GLYCOPYRROLATE
Glycopyrrolate	GLYCOPYRROLATE	Hikma Pharmaceuticals USA Inc.	516cc4f8-3583-4405-ab66-29d4fcc56d05	2022-03-23	Warnings, Adverse reactions	Name fallback brand name: Glycopyrrolate generic name: GLYCOPYRROLATE
Glycopyrrolate	GLYCOPYRROLATE	Hikma Pharmaceuticals USA Inc.	d5a18d74-0d40-46e2-aa0a-41d18609a536	2022-03-04	Warnings, Adverse reactions	Name fallback brand name: Glycopyrrolate generic name: GLYCOPYRROLATE
glycopyrrolate	GLYCOPYRROLATE	BE Pharmaceuticals Inc.	d9df3900-a8c2-438b-8971-ba11ff91f90b	2022-02-24	Warnings, Adverse reactions	Name fallback brand name: glycopyrrolate generic name: GLYCOPYRROLATE
Glycopyrrolate	GLYCOPYRROLATE	Somerset Therapeutics, LLC	a46c5ec1-a1b4-46fc-9b37-8da7f0c983d6	2022-01-27	Warnings, Adverse reactions	Name fallback brand name: Glycopyrrolate generic name: GLYCOPYRROLATE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.