Application 090020

Type: ANDA
Sponsor: OXFORD PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	GLYCOPYRROLATE	GLYCOPYRROLATE	TABLET;ORAL	1MG	No	No
002	GLYCOPYRROLATE	GLYCOPYRROLATE	TABLET;ORAL	2MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A090020-001	GLYCOPYRROLATE	GLYCOPYRROLATE	1MG	TABLET / ORAL	AA		2011-10-19
A090020-002	GLYCOPYRROLATE	GLYCOPYRROLATE	2MG	TABLET / ORAL	AA		2011-10-19

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A090020-001	AA
A090020-002	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.

Product history page 1 of 3 · 84 observed 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
2026-08-18 06:07:40	2026-07	A090020-001	GLYCOPYRROLATE	1MG	TABLET / ORAL	AA	2011-10-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090020-002	GLYCOPYRROLATE	2MG	TABLET / ORAL	AA	2011-10-19	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A090020-001	GLYCOPYRROLATE	1MG	TABLET / ORAL	AA	2011-10-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090020-002	GLYCOPYRROLATE	2MG	TABLET / ORAL	AA	2011-10-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090020-001	GLYCOPYRROLATE	1MG	TABLET / ORAL	AA	2011-10-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090020-002	GLYCOPYRROLATE	2MG	TABLET / ORAL	AA	2011-10-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090020-001	GLYCOPYRROLATE	1MG	TABLET / ORAL	AA	2011-10-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090020-002	GLYCOPYRROLATE	2MG	TABLET / ORAL	AA	2011-10-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090020-001	GLYCOPYRROLATE	1MG	TABLET / ORAL	AA	2011-10-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090020-002	GLYCOPYRROLATE	2MG	TABLET / ORAL	AA	2011-10-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090020-001	GLYCOPYRROLATE	1MG	TABLET / ORAL	AA	2011-10-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090020-002	GLYCOPYRROLATE	2MG	TABLET / ORAL	AA	2011-10-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090020-001	GLYCOPYRROLATE	1MG	TABLET / ORAL	AA	2011-10-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090020-002	GLYCOPYRROLATE	2MG	TABLET / ORAL	AA	2011-10-19	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090020-001	GLYCOPYRROLATE	1MG	TABLET / ORAL	AA	2011-10-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090020-002	GLYCOPYRROLATE	2MG	TABLET / ORAL	AA	2011-10-19	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090020-001	GLYCOPYRROLATE	1MG	TABLET / ORAL	AA	2011-10-19	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090020-002	GLYCOPYRROLATE	2MG	TABLET / ORAL	AA	2011-10-19	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090020-001	GLYCOPYRROLATE	1MG	TABLET / ORAL	AA	2011-10-19	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090020-002	GLYCOPYRROLATE	2MG	TABLET / ORAL	AA	2011-10-19	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090020-001	GLYCOPYRROLATE	1MG	TABLET / ORAL	AA	2011-10-19	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090020-002	GLYCOPYRROLATE	2MG	TABLET / ORAL	AA	2011-10-19	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090020-001	GLYCOPYRROLATE	1MG	TABLET / ORAL	AA	2011-10-19	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090020-002	GLYCOPYRROLATE	2MG	TABLET / ORAL	AA	2011-10-19	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090020-001	GLYCOPYRROLATE	1MG	TABLET / ORAL	AA	2011-10-19	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090020-002	GLYCOPYRROLATE	2MG	TABLET / ORAL	AA	2011-10-19	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090020-001	GLYCOPYRROLATE	1MG	TABLET / ORAL	AA	2011-10-19	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090020-002	GLYCOPYRROLATE	2MG	TABLET / ORAL	AA	2011-10-19	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090020-001	GLYCOPYRROLATE	1MG	TABLET / ORAL	AA	2011-10-19	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A090020-002	GLYCOPYRROLATE	2MG	TABLET / ORAL	AA	2011-10-19	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090020-001	GLYCOPYRROLATE	1MG	TABLET / ORAL	AA	2011-10-19	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090020-002	GLYCOPYRROLATE	2MG	TABLET / ORAL	AA	2011-10-19	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090020-001	GLYCOPYRROLATE	1MG	TABLET / ORAL	AA	2011-10-19	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A090020-002	GLYCOPYRROLATE	2MG	TABLET / ORAL	AA	2011-10-19	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090020-001	GLYCOPYRROLATE	1MG	TABLET / ORAL	AA	2011-10-19	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A090020-002	GLYCOPYRROLATE	2MG	TABLET / ORAL	AA	2011-10-19	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090020-001	GLYCOPYRROLATE	1MG	TABLET / ORAL	AA	2011-10-19	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A090020-002	GLYCOPYRROLATE	2MG	TABLET / ORAL	AA	2011-10-19	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090020-001	GLYCOPYRROLATE	1MG	TABLET / ORAL	AA	2011-10-19	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A090020-002	GLYCOPYRROLATE	2MG	TABLET / ORAL	AA	2011-10-19	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A090020-001	AA	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090020-002	AA	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A090020-001	AA	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090020-002	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090020-001	AA	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090020-002	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090020-001	AA	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090020-002	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090020-001	AA	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090020-002	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090020-001	AA	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090020-002	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090020-001	AA	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090020-002	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090020-001	AA	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090020-002	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090020-001	AA	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090020-002	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090020-001	AA	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090020-002	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090020-001	AA	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090020-002	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090020-001	AA	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090020-002	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090020-001	AA	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090020-002	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090020-001	AA	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090020-002	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090020-001	AA	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A090020-002	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090020-001	AA	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090020-002	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090020-001	AA	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A090020-002	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090020-001	AA	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A090020-002	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090020-001	AA	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A090020-002	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090020-001	AA	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A090020-002	AA	1	`bb7c543d1eb4…`

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 · 116 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
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	REMEDYREPACK INC.	5d7a742e-2bcf-4db4-a07c-f669938e4068	2025-12-17	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 Oral Solution	GLYCOPYRROLATE	Granules Pharmaceuticals Inc.	0f05c5d3-9c41-4dae-88d1-18cbddc69487	2025-12-02	Warnings, Adverse reactions	Name fallback generic name: GLYCOPYRROLATE
Glycopyrrolate	GLYCOPYRROLATE	Amneal Pharmaceuticals LLC	bbab4cf1-0441-4fc4-9de9-e4117fa19faa	2025-12-01	Warnings, Adverse reactions	Name fallback brand name: Glycopyrrolate generic name: GLYCOPYRROLATE
GLYCOPYRROLATE	GLYCOPYRROLATE	Solco Healthcare US, LLC	2972f22e-378c-450b-8869-1354a9bd0ffc	2025-11-30	Warnings, Adverse reactions	Name fallback brand name: GLYCOPYRROLATE generic name: GLYCOPYRROLATE
GLYCOPYRROLATE	GLYCOPYRROLATE	Solco Healthcare US, LLC	3707f06a-6cba-4f5c-86ab-fb95bc2a933c	2025-11-30	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	Henry Schein, Inc.	83602e34-7a8c-4606-b43e-23ab909b6c1a	2025-11-05	Warnings, Adverse reactions	Name fallback brand name: Glycopyrrolate generic name: GLYCOPYRROLATE
Glycopyrrolate	GLYCOPYRROLATE	Henry Schein, Inc.	74d51ba3-0ca0-4a04-aa87-1c243f885bd8	2025-11-05	Warnings, Adverse reactions	Name fallback brand name: Glycopyrrolate generic name: GLYCOPYRROLATE
Glycopyrrolate	GLYCOPYRROLATE	Henry Schein, Inc.	4ecb3435-58e5-46cb-b8c2-85b5fd955f83	2025-11-03	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