Application 207639

Type: ANDA
Sponsor: SOMERSET THERAPS LLC

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 1.

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
A207639-001	GLYCOPYRROLATE	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP		2017-06-23

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A207639-001	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 · 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
2026-02-19 14:30 UTC	2026-02	A207639-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2017-06-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207639-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2017-06-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207639-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2017-06-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207639-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2017-06-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207639-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2017-06-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207639-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2017-06-23	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207639-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2017-06-23	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207639-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2017-06-23	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207639-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2017-06-23	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207639-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2017-06-23	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207639-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2017-06-23	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207639-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2017-06-23	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207639-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2017-06-23	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207639-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2017-06-23	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207639-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2017-06-23	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A207639-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2017-06-23	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A207639-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2017-06-23	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A207639-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2017-06-23	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A207639-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2017-06-23	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A207639-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2017-06-23	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A207639-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2017-06-23	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A207639-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2017-06-23	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A207639-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2017-06-23	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A207639-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2017-06-23	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A207639-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2017-06-23	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A207639-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2017-06-23	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A207639-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2017-06-23	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A207639-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2017-06-23	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A207639-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2017-06-23	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A207639-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2017-06-23	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A207639-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2017-06-23	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A207639-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2017-06-23	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A207639-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2017-06-23	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A207639-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2017-06-23	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A207639-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2017-06-23	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A207639-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2017-06-23	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A207639-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2017-06-23	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A207639-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2017-06-23	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A207639-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2017-06-23	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A207639-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2017-06-23	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A207639-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207639-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207639-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207639-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207639-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207639-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207639-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207639-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207639-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207639-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207639-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207639-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207639-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207639-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207639-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A207639-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A207639-001	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A207639-001	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A207639-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A207639-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A207639-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A207639-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A207639-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A207639-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A207639-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A207639-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A207639-001	AP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A207639-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A207639-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A207639-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A207639-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A207639-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A207639-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A207639-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A207639-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A207639-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A207639-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A207639-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A207639-001	AP	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A207639-001	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 1 of 1 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
GLYCOPYRROLATE	GLYCOPYRROLATE	Somerset Therapeutics, LLC	48cfbd5a-b133-4720-9bd7-65296064ea3c	2024-08-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207639 application number: ANDA207639 ndc (product): 70069-616
Glycopyrrolate	GLYCOPYRROLATE	Medical Purchasing Solutions, LLC	66726c2b-27e8-5dd1-e053-2991aa0a1ba7	2023-06-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207639 application number: ANDA207639 ndc (product): 71872-7012
Glycopyrrolate	GLYCOPYRROLATE	Medical Purchasing Solutions, LLC	69353cc1-f5d4-170b-e053-2a91aa0ad5a5	2023-05-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207639 application number: ANDA207639 ndc (product): 71872-7094
Glycopyrrolate	GLYCOPYRROLATE	Medical Purchasing Solutions, LLC	6934f467-949f-97cc-e053-2a91aa0a05fb	2023-05-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207639 application number: ANDA207639 ndc (product): 71872-7093
Glycopyrrolate	GLYCOPYRROLATE	Somerset Therapeutics, LLC	a46c5ec1-a1b4-46fc-9b37-8da7f0c983d6	2022-01-27	Warnings, Adverse reactions	Exact identifier ndc (product): 70069-014 ndc (product): 70069-011 ndc (product): 70069-012 ndc (product): 70069-013

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 23 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
70069-011	Glycopyrrolate	Glycopyrrolate	Somerset Therapeutics, LLC	ANDA	Current
70069-011	Glycopyrrolate	Glycopyrrolate	Somerset Therapeutics, LLC	ANDA	Current
70069-011	Glycopyrrolate	Glycopyrrolate	Somerset Therapeutics, LLC	ANDA	Current
70069-011	Glycopyrrolate	Glycopyrrolate	Somerset Therapeutics, LLC	ANDA	Current
70069-012	Glycopyrrolate	Glycopyrrolate	Somerset Therapeutics, LLC	ANDA	Current
70069-012	Glycopyrrolate	Glycopyrrolate	Somerset Therapeutics, LLC	ANDA	Current
70069-012	Glycopyrrolate	Glycopyrrolate	Somerset Therapeutics, LLC	ANDA	Current
70069-012	Glycopyrrolate	Glycopyrrolate	Somerset Therapeutics, LLC	ANDA	Current
70069-013	Glycopyrrolate	Glycopyrrolate	Somerset Therapeutics, LLC	ANDA	Current
70069-013	Glycopyrrolate	Glycopyrrolate	Somerset Therapeutics, LLC	ANDA	Current
70069-013	Glycopyrrolate	Glycopyrrolate	Somerset Therapeutics, LLC	ANDA	Current
70069-013	Glycopyrrolate	Glycopyrrolate	Somerset Therapeutics, LLC	ANDA	Current
70069-014	Glycopyrrolate	Glycopyrrolate	Somerset Therapeutics, LLC	ANDA	Current
70069-014	Glycopyrrolate	Glycopyrrolate	Somerset Therapeutics, LLC	ANDA	Current
70069-014	Glycopyrrolate	Glycopyrrolate	Somerset Therapeutics, LLC	ANDA	Current
70069-014	Glycopyrrolate	Glycopyrrolate	Somerset Therapeutics, LLC	ANDA	Current
70069-616	GLYCOPYRROLATE	GLYCOPYRROLATE	Somerset Therapeutics, LLC	ANDA	Current
71872-7012	Glycopyrrolate	Glycopyrrolate	Medical Purchasing Solutions, LLC	ANDA	Current
71872-7012	Glycopyrrolate	Glycopyrrolate	Medical Purchasing Solutions, LLC	ANDA	Current
71872-7093	Glycopyrrolate	Glycopyrrolate	Medical Purchasing Solutions, LLC	ANDA	Current
71872-7093	Glycopyrrolate	Glycopyrrolate	Medical Purchasing Solutions, LLC	ANDA	Current
71872-7094	Glycopyrrolate	Glycopyrrolate	Medical Purchasing Solutions, LLC	ANDA	Current
71872-7094	Glycopyrrolate	Glycopyrrolate	Medical Purchasing Solutions, LLC	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
48838	ORIG	2017-06-27