Application 212612

Type: ANDA
Sponsor: GLAND PHARMA LTD

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
A212612-001	GLYCOPYRROLATE	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP		2019-09-30

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A212612-001	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
2026-02-19 14:30 UTC	2026-02	A212612-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2019-09-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212612-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2019-09-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212612-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2019-09-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212612-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2019-09-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212612-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2019-09-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212612-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2019-09-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212612-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2019-09-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212612-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2019-09-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212612-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2019-09-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212612-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2019-09-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212612-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2019-09-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212612-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2019-09-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212612-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2019-09-30	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A212612-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2019-09-30	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212612-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2019-09-30	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A212612-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2019-09-30	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A212612-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2019-09-30	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A212612-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2019-09-30	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A212612-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2019-09-30	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A212612-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2019-09-30	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A212612-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2019-09-30	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A212612-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2019-09-30	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A212612-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2019-09-30	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A212612-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2019-09-30	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A212612-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2019-09-30	`3f01610625f2…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A212612-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2019-09-30	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A212612-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2019-09-30	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A212612-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2019-09-30	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A212612-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2019-09-30	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A212612-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2019-09-30	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A212612-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2019-09-30	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A212612-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2019-09-30	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A212612-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2019-09-30	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A212612-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2019-09-30	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A212612-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2019-09-30	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A212612-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2019-09-30	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A212612-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2019-09-30	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A212612-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2019-09-30	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A212612-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2019-09-30	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A212612-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212612-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212612-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212612-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212612-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212612-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212612-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212612-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212612-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212612-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212612-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212612-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212612-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A212612-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212612-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A212612-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A212612-001	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A212612-001	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A212612-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A212612-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A212612-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A212612-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A212612-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A212612-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A212612-001	AP	1	`3f01610625f2…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A212612-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A212612-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A212612-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A212612-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A212612-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A212612-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A212612-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A212612-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A212612-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A212612-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A212612-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A212612-001	AP	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A212612-001	AP	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A212612-001	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 · 7 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Glycopyrrolate	GLYCOPYRROLATE	Gland Pharma Limited	d670bd26-8a44-44be-90e1-107d4c380233	2026-04-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212612 application number: ANDA212612 ndc (product): 68083-378 ndc (product): 68083-379 ndc (product): 68083-377 ndc (product): 68083-376
Glycopyrrolate	GLYCOPYRROLATE	Jvet Pharmaceuticals LLC	4b335c67-4f8f-47e5-abfc-f8c2c15496d7	2025-12-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212612 application number: ANDA212612
Glycopyrrolate	GLYCOPYRROLATE	Medical Purchasing Solutions, LLC	0933e843-df2a-3d32-e063-6394a90a1037	2023-11-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212612 application number: ANDA212612
Glycopyrrolate	GLYCOPYRROLATE	Medical Purchasing Solutions, LLC	b622f21f-fa37-1259-e053-2995a90aa796	2023-05-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212612 application number: ANDA212612 ndc (product): 71872-7224
Glycopyrrolate	GLYCOPYRROLATE	Medical Purchasing Solutions, LLC	ea4c8be4-a1e9-5901-e053-2995a90a5e63	2023-04-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212612 application number: ANDA212612 ndc (product): 71872-7292
Glycopyrrolate	GLYCOPYRROLATE	Xiromed LLC	29618edf-39b0-022a-9875-9d865450d318	2022-04-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212612 application number: ANDA212612 ndc (product): 70700-168 ndc (product): 70700-167 ndc (product): 70700-165 ndc (product): 70700-166
Glycopyrrolate	GLYCOPYRROLATE	Xiromed, LLC	f777c813-3232-d744-8bcf-58e86fb929bd	2022-04-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212612 application number: ANDA212612 ndc (product): 70700-903 ndc (product): 70700-902

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 28 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
50090-5226	Glycopyrrolate	Glycopyrrolate	A-S Medication Solutions	ANDA	Current
50090-5227	Glycopyrrolate	Glycopyrrolate	A-S Medication Solutions	ANDA	Current
68083-376	Glycopyrrolate	Glycopyrrolate	Gland Pharma Limited	ANDA	Current
68083-376	Glycopyrrolate	Glycopyrrolate	Gland Pharma Limited	ANDA	Current
68083-377	Glycopyrrolate	Glycopyrrolate	Gland Pharma Limited	ANDA	Current
68083-377	Glycopyrrolate	Glycopyrrolate	Gland Pharma Limited	ANDA	Current
68083-378	Glycopyrrolate	Glycopyrrolate	Gland Pharma Limited	ANDA	Current
68083-378	Glycopyrrolate	Glycopyrrolate	Gland Pharma Limited	ANDA	Current
68083-379	Glycopyrrolate	Glycopyrrolate	Gland Pharma Limited	ANDA	Current
68083-379	Glycopyrrolate	Glycopyrrolate	Gland Pharma Limited	ANDA	Current
70700-165	Glycopyrrolate	Glycopyrrolate	Xiromed LLC	ANDA	Current
70700-165	Glycopyrrolate	Glycopyrrolate	Xiromed LLC	ANDA	Current
70700-165	Glycopyrrolate	Glycopyrrolate	Xiromed LLC	ANDA	Current
70700-166	Glycopyrrolate	Glycopyrrolate	Xiromed LLC	ANDA	Current
70700-166	Glycopyrrolate	Glycopyrrolate	Xiromed LLC	ANDA	Current
70700-166	Glycopyrrolate	Glycopyrrolate	Xiromed LLC	ANDA	Current
70700-167	Glycopyrrolate	Glycopyrrolate	Xiromed LLC	ANDA	Current
70700-167	Glycopyrrolate	Glycopyrrolate	Xiromed LLC	ANDA	Current
70700-167	Glycopyrrolate	Glycopyrrolate	Xiromed LLC	ANDA	Current
70700-168	Glycopyrrolate	Glycopyrrolate	Xiromed LLC	ANDA	Current
70700-168	Glycopyrrolate	Glycopyrrolate	Xiromed LLC	ANDA	Current
70700-168	Glycopyrrolate	Glycopyrrolate	Xiromed LLC	ANDA	Current
70700-902	Glycopyrrolate	Glycopyrrolate	Xiromed, LLC	ANDA	Current
70700-902	Glycopyrrolate	Glycopyrrolate	Xiromed, LLC	ANDA	Current
70700-903	Glycopyrrolate	Glycopyrrolate	Xiromed, LLC	ANDA	Current
70700-903	Glycopyrrolate	Glycopyrrolate	Xiromed, LLC	ANDA	Current
71872-7224	Glycopyrrolate	Glycopyrrolate	Medical Purchasing Solutions, LLC	ANDA	Current
71872-7292	Glycopyrrolate	Glycopyrrolate	Medical Purchasing Solutions, LLC	ANDA	Current