Application 211705

Type: ANDA
Sponsor: CAPLIN

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
A211705-001	GLYCOPYRROLATE	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP		2019-03-20

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A211705-001	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	A211705-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2019-03-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211705-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2019-03-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211705-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2019-03-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211705-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2019-03-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211705-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2019-03-20	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211705-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2019-03-20	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211705-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2019-03-20	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211705-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2019-03-20	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211705-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2019-03-20	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211705-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2019-03-20	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211705-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2019-03-20	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211705-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2019-03-20	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211705-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2019-03-20	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A211705-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2019-03-20	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211705-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2019-03-20	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A211705-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2019-03-20	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A211705-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2019-03-20	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A211705-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2019-03-20	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A211705-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2019-03-20	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A211705-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2019-03-20	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A211705-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2019-03-20	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A211705-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2019-03-20	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A211705-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2019-03-20	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A211705-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2019-03-20	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A211705-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2019-03-20	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A211705-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2019-03-20	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A211705-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2019-03-20	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A211705-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2019-03-20	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A211705-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2019-03-20	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A211705-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2019-03-20	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A211705-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2019-03-20	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A211705-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2019-03-20	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A211705-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2019-03-20	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A211705-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2019-03-20	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A211705-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2019-03-20	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A211705-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2019-03-20	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A211705-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2019-03-20	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A211705-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2019-03-20	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A211705-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2019-03-20	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A211705-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2019-03-20	`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	A211705-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211705-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211705-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211705-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211705-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211705-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211705-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211705-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211705-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211705-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211705-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211705-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211705-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A211705-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211705-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A211705-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A211705-001	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A211705-001	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A211705-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A211705-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A211705-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A211705-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A211705-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A211705-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A211705-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A211705-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A211705-001	AP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A211705-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A211705-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A211705-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A211705-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A211705-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A211705-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A211705-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A211705-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A211705-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A211705-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A211705-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A211705-001	AP	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A211705-001	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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Glycopyrrolate	GLYCOPYRROLATE	Caplin Steriles Limited	765490fa-8378-40c8-9fa7-b0bfa2e1a0a9	2025-01-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211705 application number: ANDA211705 ndc (product): 65145-102 ndc (product): 65145-104 ndc (product): 65145-105 ndc (product): 65145-103
glycopyrrolate	GLYCOPYRROLATE	BE Pharmaceuticals Inc.	d9df3900-a8c2-438b-8971-ba11ff91f90b	2022-02-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211705 application number: ANDA211705 ndc (product): 71839-125 ndc (product): 71839-123 ndc (product): 71839-126 ndc (product): 71839-124
Glycopyrrolate	GLYCOPYRROLATE	Somerset Therapeutics, LLC	a46c5ec1-a1b4-46fc-9b37-8da7f0c983d6	2022-01-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211705 application number: ANDA211705 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 · 24 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
16714-906	Glycopyrrolate	Glycopyrrolate	NorthStar Rx LLC	ANDA	Current
16714-906	Glycopyrrolate	Glycopyrrolate	NorthStar Rx LLC	ANDA	Current
16714-906	Glycopyrrolate	Glycopyrrolate	NorthStar Rx LLC	ANDA	Current
16714-998	Glycopyrrolate	Glycopyrrolate	NorthStar Rx LLC	ANDA	Current
16714-998	Glycopyrrolate	Glycopyrrolate	NorthStar Rx LLC	ANDA	Current
16714-998	Glycopyrrolate	Glycopyrrolate	NorthStar Rx LLC	ANDA	Current
65145-102	Glycopyrrolate	Glycopyrrolate	Caplin Steriles Limited	ANDA	Current
65145-103	Glycopyrrolate	Glycopyrrolate	Caplin Steriles Limited	ANDA	Current
65145-104	Glycopyrrolate	Glycopyrrolate	Caplin Steriles Limited	ANDA	Current
65145-105	Glycopyrrolate	Glycopyrrolate	Caplin Steriles Limited	ANDA	Current
70069-011	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
70069-014	Glycopyrrolate	Glycopyrrolate	Somerset Therapeutics, LLC	ANDA	Current
71288-407	Glycopyrrolate	Glycopyrrolate	Meitheal Pharmaceuticals Inc.	ANDA	Current
71288-407	Glycopyrrolate	Glycopyrrolate	Meitheal Pharmaceuticals Inc.	ANDA	Current
71288-407	Glycopyrrolate	Glycopyrrolate	Meitheal Pharmaceuticals Inc.	ANDA	Current
71288-408	Glycopyrrolate	Glycopyrrolate	Meitheal Pharmaceuticals Inc.	ANDA	Current
71288-408	Glycopyrrolate	Glycopyrrolate	Meitheal Pharmaceuticals Inc.	ANDA	Current
71288-408	Glycopyrrolate	Glycopyrrolate	Meitheal Pharmaceuticals Inc.	ANDA	Current
71839-123	glycopyrrolate	glycopyrrolate	BE Pharmaceuticals Inc.	ANDA	Current
71839-124	glycopyrrolate	glycopyrrolate	BE Pharmaceuticals Inc.	ANDA	Current
71839-125	glycopyrrolate	glycopyrrolate	BE Pharmaceuticals Inc.	ANDA	Current
71839-126	glycopyrrolate	glycopyrrolate	BE Pharmaceuticals Inc.	ANDA	Current