Application 212591

Type: ANDA
Sponsor: NIVAGEN PHARMS INC

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
A212591-001	GLYCOPYRROLATE	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP		2021-10-13

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A212591-001	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.

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	A212591-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2021-10-13	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A212591-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2021-10-13	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A212591-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2021-10-13	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212591-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2021-10-13	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212591-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2021-10-13	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212591-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2021-10-13	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212591-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2021-10-13	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212591-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2021-10-13	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212591-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2021-10-13	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212591-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2021-10-13	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212591-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2021-10-13	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212591-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2021-10-13	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212591-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2021-10-13	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212591-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2021-10-13	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212591-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2021-10-13	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A212591-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2021-10-13	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212591-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2021-10-13	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A212591-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2021-10-13	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A212591-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2021-10-13	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A212591-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2021-10-13	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A212591-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2021-10-13	`782e0a99824c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A212591-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2021-10-13	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A212591-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2021-10-13	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A212591-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2021-10-13	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A212591-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2021-10-13	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A212591-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2021-10-13	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A212591-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2021-10-13	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A212591-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2021-10-13	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A212591-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2021-10-13	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A212591-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2021-10-13	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A212591-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2021-10-13	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A212591-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2021-10-13	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A212591-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2021-10-13	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A212591-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2021-10-13	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A212591-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2021-10-13	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A212591-001	AP	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A212591-001	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A212591-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212591-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212591-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212591-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212591-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212591-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212591-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212591-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212591-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212591-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212591-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212591-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212591-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A212591-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212591-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A212591-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A212591-001	AP	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A212591-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A212591-001	AP	1	`782e0a99824c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A212591-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A212591-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A212591-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A212591-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A212591-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A212591-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A212591-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A212591-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A212591-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A212591-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A212591-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A212591-001	AP	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A212591-001	AP	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A212591-001	AP	1	`a50c72e98297…`

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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
GLYCOPYRROLATE	GLYCOPYRROLATE	Nivagen Pharmaceuticals, Inc.	7cb1ecbe-1e7a-4b39-8e1d-0c20f145e177	2021-10-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212591 application number: ANDA212591 ndc (product): 75834-193 ndc (product): 75834-194 ndc (product): 75834-195 ndc (product): 75834-196

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 4 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
75834-193	GLYCOPYRROLATE	glycopyrrolate	Nivagen Pharmaceuticals, Inc.	ANDA	Current
75834-194	GLYCOPYRROLATE	glycopyrrolate	Nivagen Pharmaceuticals, Inc.	ANDA	Current
75834-195	GLYCOPYRROLATE	glycopyrrolate	Nivagen Pharmaceuticals, Inc.	ANDA	Current
75834-196	GLYCOPYRROLATE	glycopyrrolate	Nivagen Pharmaceuticals, Inc.	ANDA	Current