Application 210927

Type: ANDA
Sponsor: PRINSTON 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 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
A210927-001	GLYCOPYRROLATE	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP		2018-10-31

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A210927-001	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	A210927-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2018-10-31	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A210927-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2018-10-31	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210927-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2018-10-31	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210927-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2018-10-31	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210927-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2018-10-31	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210927-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2018-10-31	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210927-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2018-10-31	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210927-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2018-10-31	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210927-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2018-10-31	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210927-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2018-10-31	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210927-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2018-10-31	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210927-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2018-10-31	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210927-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2018-10-31	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210927-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2018-10-31	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210927-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2018-10-31	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210927-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2018-10-31	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A210927-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2018-10-31	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A210927-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2018-10-31	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A210927-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2018-10-31	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A210927-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2018-10-31	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A210927-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2018-10-31	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A210927-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2018-10-31	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A210927-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2018-10-31	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A210927-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2018-10-31	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A210927-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2018-10-31	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A210927-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2018-10-31	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A210927-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2018-10-31	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A210927-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2018-10-31	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A210927-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2018-10-31	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A210927-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2018-10-31	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A210927-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2018-10-31	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A210927-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2018-10-31	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A210927-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2018-10-31	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A210927-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2018-10-31	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A210927-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2018-10-31	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A210927-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2018-10-31	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A210927-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2018-10-31	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A210927-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2018-10-31	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A210927-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2018-10-31	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A210927-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2018-10-31	`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	A210927-001	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A210927-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210927-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210927-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210927-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210927-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210927-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210927-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210927-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210927-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210927-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210927-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210927-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210927-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210927-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210927-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A210927-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A210927-001	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A210927-001	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A210927-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A210927-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A210927-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A210927-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A210927-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A210927-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A210927-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A210927-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A210927-001	AP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A210927-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A210927-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A210927-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A210927-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A210927-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A210927-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A210927-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A210927-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A210927-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A210927-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A210927-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A210927-001	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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
GLYCOPYRROLATE	GLYCOPYRROLATE	Solco Healthcare US, LLC	2972f22e-378c-450b-8869-1354a9bd0ffc	2025-11-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210927 application number: ANDA210927 ndc (product): 43547-640 ndc (product): 43547-639
GLYCOPYRROLATE	GLYCOPYRROLATE	Solco Healthcare US, LLC	3707f06a-6cba-4f5c-86ab-fb95bc2a933c	2025-11-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210927 application number: ANDA210927 ndc (product): 43547-544 ndc (product): 43547-543
GLYCOPYRROLATE	GLYCOPYRROLATE	ProPharma Distribution	3edcc39d-0e29-4585-e063-6394a90ad512	2025-09-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210927 application number: ANDA210927
GLYCOPYRROLATE	GLYCOPYRROLATE	Medical Purchasing Solutions, LLC	a2a2a03f-21cc-5fec-e053-2995a90a84cb	2023-05-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210927 application number: ANDA210927 ndc (product): 71872-7208

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 5 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
43547-543	GLYCOPYRROLATE	glycopyrrolate	Solco Healthcare US, LLC	ANDA	Current
43547-544	GLYCOPYRROLATE	glycopyrrolate	Solco Healthcare US, LLC	ANDA	Current
43547-639	GLYCOPYRROLATE	glycopyrrolate	Solco Healthcare US, LLC	ANDA	Current
43547-640	GLYCOPYRROLATE	glycopyrrolate	Solco Healthcare US, LLC	ANDA	Current
71872-7208	GLYCOPYRROLATE	glycopyrrolate	Medical Purchasing Solutions, LLC	ANDA	Current