Application 210842

Type: ANDA
Sponsor: PIRAMAL CRITICAL

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 42.

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
A210842-001	GLYCOPYRROLATE	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP		2018-10-25

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A210842-001	AP

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 · 42 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	A210842-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2018-10-25	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A210842-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2018-10-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210842-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2018-10-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210842-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2018-10-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210842-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2018-10-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210842-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2018-10-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210842-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2018-10-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210842-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2018-10-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210842-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2018-10-25	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210842-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2018-10-25	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210842-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2018-10-25	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210842-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2018-10-25	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210842-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2018-10-25	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210842-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2018-10-25	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210842-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2018-10-25	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210842-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2018-10-25	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A210842-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2018-10-25	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A210842-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2018-10-25	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A210842-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2018-10-25	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A210842-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2018-10-25	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A210842-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2018-10-25	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A210842-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2018-10-25	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A210842-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2018-10-25	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A210842-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2018-10-25	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A210842-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2018-10-25	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A210842-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2018-10-25	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A210842-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2018-10-25	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A210842-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2018-10-25	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A210842-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2018-10-25	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A210842-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2018-10-25	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A210842-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2018-10-25	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A210842-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2018-10-25	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A210842-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2018-10-25	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A210842-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2018-10-25	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A210842-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2018-10-25	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A210842-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2018-10-25	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A210842-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2018-10-25	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A210842-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2018-10-25	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A210842-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2018-10-25	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A210842-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2018-10-25	`e64feba35796…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 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	A210842-001	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A210842-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210842-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210842-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210842-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210842-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210842-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210842-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210842-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210842-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210842-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210842-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210842-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210842-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210842-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210842-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A210842-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A210842-001	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A210842-001	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A210842-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A210842-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A210842-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A210842-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A210842-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A210842-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A210842-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A210842-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A210842-001	AP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A210842-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A210842-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A210842-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A210842-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A210842-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A210842-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A210842-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A210842-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A210842-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A210842-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A210842-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A210842-001	AP	1	`e64feba35796…`

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 1 of 1 · 10 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Glycopyrrolate	GLYCOPYRROLATE	Piramal Critical Care Inc	83d70378-011b-4ce3-e053-2991aa0a22be	2026-06-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210842 application number: ANDA210842 ndc (product): 66794-202 ndc (product): 66794-204 ndc (product): 66794-203 ndc (product): 66794-205
Glycopyrrolate	GLYCOPYRROLATE	ProPharma Distribution	430635e8-7c9e-77f6-e063-6294a90a4c8a	2025-11-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210842 application number: ANDA210842
Glycopyrrolate	GLYCOPYRROLATE	Henry Schein, Inc.	83602e34-7a8c-4606-b43e-23ab909b6c1a	2025-11-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210842 application number: ANDA210842
Glycopyrrolate	GLYCOPYRROLATE	Henry Schein, Inc.	74d51ba3-0ca0-4a04-aa87-1c243f885bd8	2025-11-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210842 application number: ANDA210842
Glycopyrrolate	GLYCOPYRROLATE	Henry Schein, Inc.	4ecb3435-58e5-46cb-b8c2-85b5fd955f83	2025-11-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210842 application number: ANDA210842
Glycopyrrolate	GLYCOPYRROLATE	ProPharma Distribution	3f2b4281-55f3-43e3-e063-6294a90a56ba	2025-09-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210842 application number: ANDA210842
Glycopyrrolate	GLYCOPYRROLATE	ProPharma Distribution	3edd6a26-dd0f-2411-e063-6394a90affa2	2025-09-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210842 application number: ANDA210842
Glycopyrrolate	GLYCOPYRROLATE	Medical Purchasing Solutions, LLC	8f126596-7fbf-7a48-e053-2995a90abac7	2023-05-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210842 application number: ANDA210842 ndc (product): 71872-7175
Glycopyrrolate	GLYCOPYRROLATE	Medical Purchasing Solutions, LLC	8f12016d-9033-00b4-e053-2a95a90ad02a	2023-05-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210842 application number: ANDA210842 ndc (product): 71872-7174
Glycopyrrolate	GLYCOPYRROLATE	Medical Purchasing Solutions, LLC	9e5113b7-1c0c-24bd-e053-2995a90ab94b	2023-05-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210842 application number: ANDA210842 ndc (product): 71872-7196

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 31 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
66794-202	Glycopyrrolate	Glycopyrrolate	Piramal Critical Care Inc	ANDA	Current
66794-202	Glycopyrrolate	Glycopyrrolate	Piramal Critical Care Inc	ANDA	Current
66794-202	Glycopyrrolate	Glycopyrrolate	Piramal Critical Care Inc	ANDA	Current
66794-202	Glycopyrrolate	Glycopyrrolate	Piramal Critical Care Inc	ANDA	Current
66794-202	Glycopyrrolate	Glycopyrrolate	Piramal Critical Care Inc	ANDA	Current
66794-202	Glycopyrrolate	Glycopyrrolate	Piramal Critical Care Inc	ANDA	Current
66794-203	Glycopyrrolate	Glycopyrrolate	Piramal Critical Care Inc	ANDA	Current
66794-203	Glycopyrrolate	Glycopyrrolate	Piramal Critical Care Inc	ANDA	Current
66794-203	Glycopyrrolate	Glycopyrrolate	Piramal Critical Care Inc	ANDA	Current
66794-203	Glycopyrrolate	Glycopyrrolate	Piramal Critical Care Inc	ANDA	Current
66794-203	Glycopyrrolate	Glycopyrrolate	Piramal Critical Care Inc	ANDA	Current
66794-203	Glycopyrrolate	Glycopyrrolate	Piramal Critical Care Inc	ANDA	Current
66794-204	Glycopyrrolate	Glycopyrrolate	Piramal Critical Care Inc	ANDA	Current
66794-204	Glycopyrrolate	Glycopyrrolate	Piramal Critical Care Inc	ANDA	Current
66794-204	Glycopyrrolate	Glycopyrrolate	Piramal Critical Care Inc	ANDA	Current
66794-204	Glycopyrrolate	Glycopyrrolate	Piramal Critical Care Inc	ANDA	Current
66794-204	Glycopyrrolate	Glycopyrrolate	Piramal Critical Care Inc	ANDA	Current
66794-204	Glycopyrrolate	Glycopyrrolate	Piramal Critical Care Inc	ANDA	Current
66794-205	Glycopyrrolate	Glycopyrrolate	Piramal Critical Care Inc	ANDA	Current
66794-205	Glycopyrrolate	Glycopyrrolate	Piramal Critical Care Inc	ANDA	Current
66794-205	Glycopyrrolate	Glycopyrrolate	Piramal Critical Care Inc	ANDA	Current
66794-205	Glycopyrrolate	Glycopyrrolate	Piramal Critical Care Inc	ANDA	Current
66794-205	Glycopyrrolate	Glycopyrrolate	Piramal Critical Care Inc	ANDA	Current
66794-205	Glycopyrrolate	Glycopyrrolate	Piramal Critical Care Inc	ANDA	Current
71361-001	Glycopyrrolate	Glycopyrrolate	Piramal Critical Care Limited	ANDA	Current
71361-002	Glycopyrrolate	Glycopyrrolate	Piramal Critical Care Limited	ANDA	Current
71361-003	Glycopyrrolate	Glycopyrrolate	Piramal Critical Care Limited	ANDA	Current
71361-004	Glycopyrrolate	Glycopyrrolate	Piramal Critical Care Limited	ANDA	Current
71872-7174	Glycopyrrolate	Glycopyrrolate	Medical Purchasing Solutions, LLC	ANDA	Current
71872-7175	Glycopyrrolate	Glycopyrrolate	Medical Purchasing Solutions, LLC	ANDA	Current
71872-7196	Glycopyrrolate	Glycopyrrolate	Medical Purchasing Solutions, LLC	ANDA	Current