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 4 of 6 · 105 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
GLYCOPYRROLATE	GLYCOPYRROLATE	HF Acquisition Co LLC, DBA HealthFirst	9be0ad4e-3efa-1a24-e053-2995a90a60d5	2024-02-22	Warnings, Adverse reactions	Name fallback brand name: GLYCOPYRROLATE generic name: GLYCOPYRROLATE
Glycopyrrolate	GLYCOPYRROLATE	American Regent, Inc.	62267afe-1a73-4623-984e-646db590ec5b	2024-02-07	Warnings, Adverse reactions	Name fallback brand name: Glycopyrrolate generic name: GLYCOPYRROLATE
GLYCOPYRROLATE	GLYCOPYRROLATE	HF Acquisition Co LLC, DBA HealthFirst	c4c3be3a-ea28-864f-e053-2a95a90a701a	2024-01-30	Warnings, Adverse reactions	Name fallback brand name: GLYCOPYRROLATE generic name: GLYCOPYRROLATE
GLYCOPYRROLATE	GLYCOPYRROLATE	HF Acquisition Co LLC, DBA HealthFirst	e76bc0e4-68f5-70b4-e053-2a95a90a451e	2024-01-22	Warnings, Adverse reactions	Name fallback brand name: GLYCOPYRROLATE generic name: GLYCOPYRROLATE
Glycopyrrolate	GLYCOPYRROLATE	Bryant Ranch Prepack	579d2499-6520-41fb-ae52-f3d8b9af8950	2024-01-12	Warnings, Adverse reactions	Name fallback brand name: Glycopyrrolate generic name: GLYCOPYRROLATE
Glycopyrrolate	GLYCOPYRROLATE	NorthStar RxLLC	ed22456b-b488-49ec-b96b-2541f5f3c955	2024-01-10	Warnings, Adverse reactions	Name fallback brand name: Glycopyrrolate generic name: GLYCOPYRROLATE
GLYCOPYRROLATE	GLYCOPYRROLATE	FH2 Pharma LLC	18ca98ed-522d-470f-bb22-908bbd7d489a	2023-12-31	Warnings, Adverse reactions	Name fallback brand name: GLYCOPYRROLATE generic name: GLYCOPYRROLATE
Glycopyrrolate	GLYCOPYRROLATE	Medical Purchasing Solutions, LLC	0933e843-df2a-3d32-e063-6394a90a1037	2023-11-02	Warnings, Adverse reactions	Name fallback brand name: Glycopyrrolate generic name: GLYCOPYRROLATE
GLYCOPYRROLATE 1ML	GLYCOPYRROLATE	XIROMED LLC	1bb2fa8a-3318-1e9a-2c79-8371bcae3d1c	2023-10-23	Warnings, Adverse reactions	Name fallback generic name: GLYCOPYRROLATE
Glycopyrrolate	GLYCOPYRROLATE	Fresenius Kabi USA, LLC	250eeef7-b1a9-45e7-a927-7807232e10be	2023-09-22	Warnings, Adverse reactions	Name fallback brand name: Glycopyrrolate generic name: GLYCOPYRROLATE
Glycopyrrolate	GLYCOPYRROLATE	Fresenius Kabi USA, LLC	54458620-d888-4df6-ae4b-78c3dfed3423	2023-08-16	Warnings, Adverse reactions	Name fallback brand name: Glycopyrrolate generic name: GLYCOPYRROLATE
Glycopyrrolate	GLYCOPYRROLATE	Fresenius Kabi USA, LLC	88d3e865-8dca-4c89-b6f7-a34c481f75b9	2023-08-16	Warnings, Adverse reactions	Name fallback brand name: Glycopyrrolate generic name: GLYCOPYRROLATE
GLYCOPYRROLATE	GLYCOPYRROLATE	Bryant Ranch Prepack	4c733750-45fe-4876-8e4f-c61c52470405	2023-06-06	Warnings, Adverse reactions	Name fallback brand name: GLYCOPYRROLATE generic name: GLYCOPYRROLATE
Glycopyrrolate	GLYCOPYRROLATE	Medical Purchasing Solutions, LLC	86abf577-562c-5eb1-e053-2a91aa0ac10f	2023-06-01	Warnings, Adverse reactions	Name fallback brand name: Glycopyrrolate generic name: GLYCOPYRROLATE
Glycopyrrolate	GLYCOPYRROLATE	Medical Purchasing Solutions, LLC	66726c2b-27e8-5dd1-e053-2991aa0a1ba7	2023-06-01	Warnings, Adverse reactions	Name fallback brand name: Glycopyrrolate generic name: GLYCOPYRROLATE
Glycopyrrolate	GLYCOPYRROLATE	Medical Purchasing Solutions, LLC	69353cc1-f5d4-170b-e053-2a91aa0ad5a5	2023-05-23	Warnings, Adverse reactions	Name fallback brand name: Glycopyrrolate generic name: GLYCOPYRROLATE
Glycopyrrolate	GLYCOPYRROLATE	Medical Purchasing Solutions, LLC	6934f467-949f-97cc-e053-2a91aa0a05fb	2023-05-23	Warnings, Adverse reactions	Name fallback brand name: Glycopyrrolate generic name: GLYCOPYRROLATE
Glycopyrrolate	GLYCOPYRROLATE	Medical Purchasing Solutions, LLC	95fbe384-eaff-1f2e-e053-2a95a90a0313	2023-05-15	Warnings, Adverse reactions	Name fallback brand name: Glycopyrrolate generic name: GLYCOPYRROLATE
Glycopyrrolate	GLYCOPYRROLATE	Medical Purchasing Solutions, LLC	8f126596-7fbf-7a48-e053-2995a90abac7	2023-05-15	Warnings, Adverse reactions	Name fallback brand name: Glycopyrrolate generic name: GLYCOPYRROLATE
Glycopyrrolate	GLYCOPYRROLATE	Medical Purchasing Solutions, LLC	8f12016d-9033-00b4-e053-2a95a90ad02a	2023-05-15	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.