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 3 of 6 · 115 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
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	Henry Schein, Inc.	8b4d1798-c0a7-4661-99cd-1e9a23c16386	2025-10-16	Warnings, Adverse reactions	Name fallback brand name: Glycopyrrolate generic name: GLYCOPYRROLATE
Glycopyrrolate	GLYCOPYRROLATE	Hikma Pharmaceuticals USA Inc.	960d2dd0-008d-4ec1-ba2e-9388b28b23e2	2025-10-09	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
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

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