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 4 of 6 · 115 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
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	48a8356e-377e-45ef-a1bf-e9ffec051749	2024-10-08	Warnings, Adverse reactions	Name fallback brand name: Glycopyrrolate generic name: GLYCOPYRROLATE
Glycopyrrolate	GLYCOPYRROLATE	Bryant Ranch Prepack	fcb295e4-038f-4d4f-8786-4fbcd1d3c298	2024-10-04	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
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

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