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 1 of 6 · 105 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
GLYCOPYRROLATE	GLYCOPYRROLATE	QUAGEN PHARMACEUTICALS LLC	62e1ba35-bc84-4818-be54-8b534a1bf93c	2026-09-10	Warnings, Adverse reactions	Name fallback brand name: GLYCOPYRROLATE generic name: GLYCOPYRROLATE
Glycopyrrolate	GLYCOPYRROLATE	Bryant Ranch Prepack	f7187ddb-ea11-4aa8-8215-a5fcf0f1ca7c	2026-09-09	Warnings, Adverse reactions	Name fallback brand name: Glycopyrrolate generic name: GLYCOPYRROLATE
Glycopyrrolate	GLYCOPYRROLATE	Henry Schein, Inc.	4ecb3435-58e5-46cb-b8c2-85b5fd955f83	2026-09-09	Warnings, Adverse reactions	Name fallback brand name: Glycopyrrolate generic name: GLYCOPYRROLATE
Glycopyrrolate	GLYCOPYRROLATE	Par Health USA, LLC	1f266d77-4f9e-44c9-a000-2f8fea3ac80b	2026-07-09	Warnings, Adverse reactions	Name fallback brand name: Glycopyrrolate generic name: GLYCOPYRROLATE
Glycopyrrolate	GLYCOPYRROLATE	Amneal Pharmaceuticals LLC	bbab4cf1-0441-4fc4-9de9-e4117fa19faa	2026-07-07	Warnings, Adverse reactions	Name fallback brand name: Glycopyrrolate generic name: GLYCOPYRROLATE
Glycopyrrolate	GLYCOPYRROLATE	Piramal Critical Care Inc	83d70378-011b-4ce3-e053-2991aa0a22be	2026-06-23	Warnings, Adverse reactions	Name fallback brand name: Glycopyrrolate generic name: GLYCOPYRROLATE
Glycopyrrolate	GLYCOPYRROLATE	Cardinal Health 107, LLC	65688bed-0d70-4b51-8301-1948b1deade1	2026-06-02	Warnings, Adverse reactions	Name fallback brand name: Glycopyrrolate generic name: GLYCOPYRROLATE
GLYCOPYRROLATE	GLYCOPYRROLATE	REMEDYREPACK INC.	220cd5f5-3d71-4fdb-9943-7468799c179f	2026-06-02	Warnings, Adverse reactions	Name fallback brand name: GLYCOPYRROLATE generic name: GLYCOPYRROLATE
GLYCOPYRROLATE	GLYCOPYRROLATE	Golden State Medical Supply, Inc.	ec15e70c-8473-469a-9f07-ea668783fa07	2026-05-27	Warnings, Adverse reactions	Name fallback brand name: GLYCOPYRROLATE generic name: GLYCOPYRROLATE
Glycopyrrolate	GLYCOPYRROLATE	Par Health USA, LLC	ff65c5d3-7ba9-4315-a884-199151eb45a5	2026-05-14	Warnings, Adverse reactions	Name fallback brand name: Glycopyrrolate generic name: GLYCOPYRROLATE
GLYCOPYRROLATE	GLYCOPYRROLATE	Bryant Ranch Prepack	098c7654-a352-47ee-bf23-6a81f8601266	2026-05-05	Warnings, Adverse reactions	Name fallback brand name: GLYCOPYRROLATE generic name: GLYCOPYRROLATE
Glycopyrrolate	GLYCOPYRROLATE	Atlantic Biologicals Corp.	50b493d7-8e3b-e459-e063-6394a90addbc	2026-04-30	Warnings, Adverse reactions	Name fallback brand name: Glycopyrrolate generic name: GLYCOPYRROLATE
Glycopyrrolate	GLYCOPYRROLATE	Gland Pharma Limited	d670bd26-8a44-44be-90e1-107d4c380233	2026-04-28	Warnings, Adverse reactions	Name fallback brand name: Glycopyrrolate generic name: GLYCOPYRROLATE
glycopyrrolate	GLYCOPYRROLATE	Amneal Pharmaceuticals LLC	741355f5-b695-41bb-a065-4abc687312b2	2026-04-28	Warnings, Adverse reactions	Name fallback brand name: glycopyrrolate generic name: GLYCOPYRROLATE
Glycopyrrolate	GLYCOPYRROLATE	Sagent Pharmaceuticals	55930f87-8964-43b1-b790-c1e6dd2602d2	2026-04-20	Warnings, Adverse reactions	Name fallback brand name: Glycopyrrolate generic name: GLYCOPYRROLATE
GLYCOPYRROLATE	GLYCOPYRROLATE	Bryant Ranch Prepack	21c7d201-c0b8-4f16-be4a-681d0b22791e	2026-04-03	Warnings, Adverse reactions	Name fallback brand name: GLYCOPYRROLATE generic name: GLYCOPYRROLATE
Glycopyrrolate	GLYCOPYRROLATE	Sandoz Inc	cb1ae370-ec4f-4114-9860-8f736f72b545	2026-04-01	Warnings, Adverse reactions	Name fallback brand name: Glycopyrrolate generic name: GLYCOPYRROLATE
Glycopyrrolate	GLYCOPYRROLATE	REMEDYREPACK INC.	a338ef22-c243-4075-b02d-bcd5b590104a	2026-03-26	Warnings, Adverse reactions	Name fallback brand name: Glycopyrrolate generic name: GLYCOPYRROLATE
Glycopyrrolate	GLYCOPYRROLATE	REMEDYREPACK INC.	fafea739-87d0-4421-833f-eb066791504c	2026-03-26	Warnings, Adverse reactions	Name fallback brand name: Glycopyrrolate generic name: GLYCOPYRROLATE
Glycopyrrolate	GLYCOPYRROLATE	Lifestar Pharma LLC	0f4a4b94-71e0-49ed-8f1e-c760e4dd3137	2026-03-25	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.