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 2 of 6 · 105 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Glycopyrrolate	GLYCOPYRROLATE	Major Pharmaceuticals	6e5bfe6d-d321-4f0f-86e2-457d8fd10a6a	2026-03-19	Warnings, Adverse reactions	Name fallback brand name: Glycopyrrolate generic name: GLYCOPYRROLATE
glycopyrrolate	GLYCOPYRROLATE	Bionpharma Inc.	512d3f1e-c35c-87c2-e063-6394a90a8de0	2026-03-05	Warnings, Adverse reactions	Name fallback brand name: glycopyrrolate generic name: GLYCOPYRROLATE
GLYCOPYRROLATE	GLYCOPYRROLATE	NCS HealthCare of KY, LLC dba Vangard Labs	5ed930b7-a36e-4bf8-b1d1-dad238d3dd18	2026-02-25	Warnings, Adverse reactions	Name fallback brand name: GLYCOPYRROLATE generic name: GLYCOPYRROLATE
Glycopyrrolate	GLYCOPYRROLATE	Bryant Ranch Prepack	10ea264f-e157-4e13-9d79-b4228daf359d	2026-02-17	Warnings, Adverse reactions	Name fallback brand name: Glycopyrrolate generic name: GLYCOPYRROLATE
Glycopyrrolate	GLYCOPYRROLATE	Florida Pharmaceutical Products, LLC	2cda1ed5-10bb-4651-acbf-be44ad709665	2026-02-12	Warnings, Adverse reactions	Name fallback brand name: Glycopyrrolate generic name: GLYCOPYRROLATE
Glycate	GLYCOPYRROLATE	Intra-Sana Laboratories	830ba1be-bef3-417c-a915-964cc6005b92	2026-01-13	Warnings, Adverse reactions	Name fallback generic name: GLYCOPYRROLATE
GLYCOPYRROLATE	GLYCOPYRROLATE	Bryant Ranch Prepack	eaf38b98-006f-4f4e-bc1c-6fe381f44b36	2026-01-07	Warnings, Adverse reactions	Name fallback brand name: GLYCOPYRROLATE generic name: GLYCOPYRROLATE
GLYCOPYRROLATE	GLYCOPYRROLATE	Bryant Ranch Prepack	b96c54a1-b8a5-4132-ae6d-725e0e5b91f4	2026-01-07	Warnings, Adverse reactions	Name fallback brand name: GLYCOPYRROLATE generic name: GLYCOPYRROLATE
Glycopyrrolate Oral Solution	GLYCOPYRROLATE	AJENAT PHARMACEUTICALS LLC	7049feaf-004a-481f-b129-996b21c3170a	2025-12-29	Warnings, Adverse reactions	Name fallback generic name: GLYCOPYRROLATE
Glycopyrrolate	GLYCOPYRROLATE	Jvet Pharmaceuticals LLC	4b335c67-4f8f-47e5-abfc-f8c2c15496d7	2025-12-19	Warnings, Adverse reactions	Name fallback brand name: Glycopyrrolate generic name: GLYCOPYRROLATE
GLYCOPYRROLATE	GLYCOPYRROLATE	Aurolife Pharma LLC	677f8495-a870-45b6-bb65-75b449f040ce	2025-12-11	Warnings, Adverse reactions	Name fallback brand name: GLYCOPYRROLATE generic name: GLYCOPYRROLATE
Glycopyrrolate	GLYCOPYRROLATE	Chartwell RX, LLC	5773cf63-4006-4d8f-b53b-c84bcfe19e4a	2025-12-10	Warnings, Adverse reactions	Name fallback brand name: Glycopyrrolate generic name: GLYCOPYRROLATE
Glycopyrrolate	GLYCOPYRROLATE	Rising Pharma Holdings, Inc.	58c4cb1f-59b8-4be9-a222-2264ca077d93	2025-12-03	Warnings, Adverse reactions	Name fallback brand name: Glycopyrrolate generic name: GLYCOPYRROLATE
Glycopyrrolate	GLYCOPYRROLATE	ProPharma Distribution	430635e8-7c9e-77f6-e063-6294a90a4c8a	2025-11-07	Warnings, Adverse reactions	Name fallback brand name: Glycopyrrolate generic name: GLYCOPYRROLATE
Glycopyrrolate	GLYCOPYRROLATE	Accord Healthcare, Inc.,	871797f0-697a-4a29-a37b-d06219e8f266	2025-10-17	Warnings, Adverse reactions	Name fallback brand name: Glycopyrrolate generic name: GLYCOPYRROLATE
Glycopyrrolate	GLYCOPYRROLATE	ProPharma Distribution	3f2b4281-55f3-43e3-e063-6294a90a56ba	2025-09-18	Warnings, Adverse reactions	Name fallback brand name: Glycopyrrolate generic name: GLYCOPYRROLATE
GLYCOPYRROLATE	GLYCOPYRROLATE	ProPharma Distribution	3edcc39d-0e29-4585-e063-6394a90ad512	2025-09-15	Warnings, Adverse reactions	Name fallback brand name: GLYCOPYRROLATE generic name: GLYCOPYRROLATE
Glycopyrrolate	GLYCOPYRROLATE	ProPharma Distribution	3edd6a26-dd0f-2411-e063-6394a90affa2	2025-09-15	Warnings, Adverse reactions	Name fallback brand name: Glycopyrrolate generic name: GLYCOPYRROLATE
Glycopyrrolate	GLYCOPYRROLATE	Alembic Pharmaceuticals Inc.	327f8a9e-7730-4f38-a7aa-fbddebddf173	2025-08-26	Warnings, Adverse reactions	Name fallback brand name: Glycopyrrolate generic name: GLYCOPYRROLATE
Glycopyrrolate	GLYCOPYRROLATE	Precision Dose, Inc.	e58f860b-e955-4d71-a128-93bd3812b08d	2025-08-08	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.