Application 210246

Type: ANDA
Sponsor: APOTEX

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	GLYCOPYRROLATE	GLYCOPYRROLATE	INJECTABLE;INJECTION	0.2MG/ML	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A210246-001	GLYCOPYRROLATE	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION			2019-10-29

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 2 · 41 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
2026-09-14 22:38:34	2026-08	A210246-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION		2019-10-29	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A210246-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION		2019-10-29	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A210246-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION		2019-10-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210246-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2019-10-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210246-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2019-10-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210246-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2019-10-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210246-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2019-10-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210246-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2019-10-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210246-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2019-10-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210246-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2019-10-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210246-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2019-10-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210246-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2019-10-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210246-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2019-10-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210246-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2019-10-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210246-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2019-10-29	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210246-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2019-10-29	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210246-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2019-10-29	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A210246-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2019-10-29	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A210246-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2019-10-29	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A210246-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2019-10-29	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A210246-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2019-10-29	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A210246-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2019-10-29	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A210246-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2019-10-29	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A210246-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2019-10-29	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A210246-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2019-10-29	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A210246-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2019-10-29	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A210246-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2019-10-29	`3f01610625f2…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A210246-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2019-10-29	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A210246-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2019-10-29	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A210246-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2019-10-29	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A210246-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2019-10-29	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A210246-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2019-10-29	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A210246-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2019-10-29	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A210246-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2019-10-29	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A210246-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2019-10-29	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A210246-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2019-10-29	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A210246-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2019-10-29	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A210246-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2019-10-29	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A210246-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2019-10-29	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A210246-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2019-10-29	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210246-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210246-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210246-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210246-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210246-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210246-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210246-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210246-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210246-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210246-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210246-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210246-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210246-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210246-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A210246-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A210246-001	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A210246-001	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A210246-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A210246-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A210246-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A210246-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A210246-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A210246-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A210246-001	AP	1	`3f01610625f2…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A210246-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A210246-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A210246-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A210246-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A210246-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A210246-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A210246-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A210246-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A210246-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A210246-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A210246-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A210246-001	AP	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A210246-001	AP	1	`cb3db0bc1861…`

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 · 115 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Glycopyrrolate	GLYCOPYRROLATE	Lifestar Pharma LLC	0f4a4b94-71e0-49ed-8f1e-c760e4dd3137	2026-03-25	Warnings, Adverse reactions	Name fallback brand name: Glycopyrrolate generic name: GLYCOPYRROLATE
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 Oral Solution	GLYCOPYRROLATE	Granules Pharmaceuticals Inc.	0f05c5d3-9c41-4dae-88d1-18cbddc69487	2025-12-02	Warnings, Adverse reactions	Name fallback 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

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 18 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
16714-536	Glycopyrrolate	Glycopyrrolate	NORTHSTAR RX LLC	ANDA	Current
16714-536	Glycopyrrolate	Glycopyrrolate	NORTHSTAR RX LLC	ANDA	Current
16714-620	Glycopyrrolate	Glycopyrrolate	NORTHSTAR RX LLC	ANDA	Current
16714-620	Glycopyrrolate	Glycopyrrolate	NORTHSTAR RX LLC	ANDA	Current
60505-6179	Glycopyrrolate	Glycopyrrolate	Apotex Corp.	ANDA	Current
60505-6179	Glycopyrrolate	Glycopyrrolate	Apotex Corp.	ANDA	Current
60505-6179	Glycopyrrolate	Glycopyrrolate	Apotex Corp.	ANDA	Current
60505-6180	Glycopyrrolate	Glycopyrrolate	Apotex Corp.	ANDA	Current
60505-6180	Glycopyrrolate	Glycopyrrolate	Apotex Corp.	ANDA	Current
60505-6180	Glycopyrrolate	Glycopyrrolate	Apotex Corp.	ANDA	Current
60505-6181	Glycopyrrolate	Glycopyrrolate	Apotex Corp.	ANDA	Current
60505-6181	Glycopyrrolate	Glycopyrrolate	Apotex Corp.	ANDA	Current
60505-6181	Glycopyrrolate	Glycopyrrolate	Apotex Corp.	ANDA	Current
60505-6182	Glycopyrrolate	Glycopyrrolate	Apotex Corp.	ANDA	Current
60505-6182	Glycopyrrolate	Glycopyrrolate	Apotex Corp.	ANDA	Current
60505-6182	Glycopyrrolate	Glycopyrrolate	Apotex Corp.	ANDA	Current
71872-7227	Glycopyrrolate	Glycopyrrolate	Medical Purchasing Solutions, LLC	ANDA	Current
71872-7237	Glycopyrrolate	Glycopyrrolate	Medical Purchasing Solutions, LLC	ANDA	Current