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 3 of 6 · 105 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
GLYRX-PF	GLYCOPYRROLATE	Exela Pharma Sciences, LLC	2189f3f5-39dc-4e85-b7c6-9515ded59686	2025-07-23	Warnings, Adverse reactions	Name fallback generic name: GLYCOPYRROLATE
GLYCOPYRROLATE	GLYCOPYRROLATE	QUAGEN PHARMACEUTICALS LLC	a456eaea-4cd6-4344-8fc6-6f6a3ce0f2c6	2025-06-14	Warnings, Adverse reactions	Name fallback brand name: GLYCOPYRROLATE generic name: GLYCOPYRROLATE
GLYCOPYRROLATE	GLYCOPYRROLATE	American Health Packaging	6404fc8e-d109-4950-9dca-c8a85ad90cf3	2025-05-18	Warnings, Adverse reactions	Name fallback brand name: GLYCOPYRROLATE generic name: GLYCOPYRROLATE
Glycopyrrolate	GLYCOPYRROLATE	Leading Pharma, LLC	498bce66-6072-4212-8413-ff9888c58f9c	2025-04-25	Warnings, Adverse reactions	Name fallback brand name: Glycopyrrolate generic name: GLYCOPYRROLATE
Glycopyrrolate	GLYCOPYRROLATE	Chartwell RX, LLC	89090b34-470c-478c-be49-1d2bc48a28f8	2025-04-17	Warnings, Adverse reactions	Name fallback brand name: Glycopyrrolate generic name: GLYCOPYRROLATE
GLYCOPYRROLATE	GLYCOPYRROLATE	Aurobindo Pharma Limited	4b3f8b3e-6fa8-471b-8bee-3dac5e3ea1b8	2025-04-17	Warnings, Adverse reactions	Name fallback brand name: GLYCOPYRROLATE generic name: GLYCOPYRROLATE
Glycopyrrolate	GLYCOPYRROLATE	AvPAK	bd497783-e2d1-130c-e053-2995a90a7fb9	2025-03-04	Warnings, Adverse reactions	Name fallback brand name: Glycopyrrolate generic name: GLYCOPYRROLATE
Glycopyrrolate	GLYCOPYRROLATE	Caplin Steriles Limited	765490fa-8378-40c8-9fa7-b0bfa2e1a0a9	2025-01-25	Warnings, Adverse reactions	Name fallback brand name: Glycopyrrolate generic name: GLYCOPYRROLATE
GLYCOPYRROLATE	GLYCOPYRROLATE	HF Acquisition Co LLC, DBA HealthFirst	9a3a142c-daaf-79af-e053-2995a90a1c51	2025-01-08	Warnings, Adverse reactions	Name fallback brand name: GLYCOPYRROLATE generic name: GLYCOPYRROLATE
GLYCOPYRROLATE	GLYCOPYRROLATE	HF Acquisition Co LLC, DBA HealthFirst	9bde90dd-0300-f705-e053-2a95a90a7ea6	2025-01-08	Warnings, Adverse reactions	Name fallback brand name: GLYCOPYRROLATE generic name: GLYCOPYRROLATE
Glycopyrrolate	GLYCOPYRROLATE	Bryant Ranch Prepack	d93a9b2b-708d-4db5-8aae-45fd3a7ca65c	2025-01-06	Warnings, Adverse reactions	Name fallback brand name: Glycopyrrolate generic name: GLYCOPYRROLATE
Cuvposa	GLYCOPYRROLATE	Merz Pharmaceuticals, LLC	d200bd44-9856-4104-a29e-a4cca3db6737	2024-12-19	Warnings, Adverse reactions	Name fallback generic name: GLYCOPYRROLATE
Glycopyrrolate	GLYCOPYRROLATE	Bryant Ranch Prepack	5ee5f433-fd99-4c8d-8263-b8956d489620	2024-12-12	Warnings, Adverse reactions	Name fallback brand name: Glycopyrrolate generic name: GLYCOPYRROLATE
glycopyrrolate	GLYCOPYRROLATE	Saptalis Pharmaceuticals, LLC.	3e6f8091-d6fe-4c8f-b897-606a70bf74bc	2024-11-12	Warnings, Adverse reactions	Name fallback brand name: glycopyrrolate generic name: GLYCOPYRROLATE
Glycopyrrolate	GLYCOPYRROLATE	Fresenius Kabi USA, LLC	ccafb5c2-86dd-4bb2-883a-c13e3171227c	2024-10-14	Warnings, Adverse reactions	Name fallback brand name: Glycopyrrolate generic name: GLYCOPYRROLATE
Glycopyrrolate	GLYCOPYRROLATE	Bryant Ranch Prepack	987ba524-361e-49c3-9e00-550a78748542	2024-10-09	Warnings, Adverse reactions	Name fallback brand name: Glycopyrrolate generic name: GLYCOPYRROLATE
Glycopyrrolate	GLYCOPYRROLATE	Bryant Ranch Prepack	33bbc475-2fe3-48ab-8a9d-56d13053593e	2024-10-04	Warnings, Adverse reactions	Name fallback brand name: Glycopyrrolate generic name: GLYCOPYRROLATE
GLYCOPYRROLATE	GLYCOPYRROLATE	Somerset Therapeutics, LLC	48cfbd5a-b133-4720-9bd7-65296064ea3c	2024-08-31	Warnings, Adverse reactions	Name fallback brand name: GLYCOPYRROLATE generic name: GLYCOPYRROLATE
Glycopyrrolate	GLYCOPYRROLATE	Bryant Ranch Prepack	bfccdb26-5047-4b54-9732-ffac2d78e4d1	2024-05-29	Warnings, Adverse reactions	Name fallback brand name: Glycopyrrolate generic name: GLYCOPYRROLATE
Glycopyrrolate	GLYCOPYRROLATE	Fresenius Kabi USA, LLC	685aaf64-1a64-42f9-a96f-4764d650c26f	2024-05-14	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.