Application 208973

Type: ANDA
Sponsor: AMNEAL

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
A208973-001	GLYCOPYRROLATE	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP		2017-06-15

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A208973-001	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	A208973-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2017-06-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208973-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2017-06-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208973-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2017-06-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208973-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2017-06-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208973-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2017-06-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208973-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2017-06-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208973-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2017-06-15	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208973-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2017-06-15	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208973-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2017-06-15	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208973-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2017-06-15	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208973-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2017-06-15	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208973-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2017-06-15	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208973-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2017-06-15	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A208973-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2017-06-15	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208973-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2017-06-15	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A208973-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2017-06-15	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A208973-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2017-06-15	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A208973-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2017-06-15	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A208973-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2017-06-15	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A208973-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2017-06-15	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A208973-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2017-06-15	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A208973-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2017-06-15	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A208973-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2017-06-15	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A208973-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2017-06-15	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A208973-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2017-06-15	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A208973-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2017-06-15	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A208973-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2017-06-15	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A208973-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2017-06-15	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A208973-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2017-06-15	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A208973-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2017-06-15	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A208973-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2017-06-15	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A208973-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2017-06-15	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A208973-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2017-06-15	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A208973-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2017-06-15	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A208973-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2017-06-15	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A208973-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2017-06-15	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A208973-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2017-06-15	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A208973-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2017-06-15	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A208973-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2017-06-15	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A208973-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2017-06-15	`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	A208973-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208973-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208973-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208973-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208973-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208973-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208973-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208973-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208973-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208973-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208973-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208973-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208973-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A208973-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208973-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A208973-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A208973-001	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A208973-001	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A208973-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A208973-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A208973-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A208973-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A208973-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A208973-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A208973-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A208973-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A208973-001	AP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A208973-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A208973-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A208973-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A208973-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A208973-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A208973-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A208973-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A208973-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A208973-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A208973-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A208973-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A208973-001	AP	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A208973-001	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	Amneal Pharmaceuticals LLC	bbab4cf1-0441-4fc4-9de9-e4117fa19faa	2025-12-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208973 application number: ANDA208973 ndc (product): 70121-1396 ndc (product): 70121-1397 ndc (product): 70121-1394 ndc (product): 70121-1395
GLYCOPYRROLATE	GLYCOPYRROLATE	HF Acquisition Co LLC, DBA HealthFirst	9a3a142c-daaf-79af-e053-2995a90a1c51	2025-01-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208973 application number: ANDA208973 ndc (product): 51662-1431 ndc (product): 51662-1425
Glycopyrrolate	GLYCOPYRROLATE	Medical Purchasing Solutions, LLC	e8bb95ed-09f1-fcf1-e053-2a95a90a93e5	2023-04-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208973 application number: ANDA208973 ndc (product): 71872-7289

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 51 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0404-9870	GLYCOPYRROLATE	glycopyrrolate	Henry Schein, Inc.	ANDA	Current
0404-9870	GLYCOPYRROLATE	glycopyrrolate	Henry Schein, Inc.	ANDA	Current
50090-4513	Glycopyrrolate	Glycopyrrolate	A-S Medication Solutions	ANDA	Current
50090-4513	Glycopyrrolate	Glycopyrrolate	A-S Medication Solutions	ANDA	Current
50090-4522	Glycopyrrolate	Glycopyrrolate	A-S Medication Solutions	ANDA	Current
50090-4522	Glycopyrrolate	Glycopyrrolate	A-S Medication Solutions	ANDA	Current
51662-1425	GLYCOPYRROLATE	GLYCOPYRROLATE	HF Acquisition Co LLC, DBA HealthFirst	ANDA	Current
51662-1425	GLYCOPYRROLATE	GLYCOPYRROLATE	HF Acquisition Co LLC, DBA HealthFirst	ANDA	Current
51662-1431	GLYCOPYRROLATE	GLYCOPYRROLATE	HF Acquisition Co LLC, DBA HealthFirst	ANDA	Current
51662-1431	GLYCOPYRROLATE	GLYCOPYRROLATE	HF Acquisition Co LLC, DBA HealthFirst	ANDA	Current
52584-396	GLYCOPYRROLATE	glycopyrrolate	General Injectables and Vaccines, Inc.	ANDA	Current
52584-396	GLYCOPYRROLATE	glycopyrrolate	General Injectables and Vaccines, Inc.	ANDA	Current
52584-396	GLYCOPYRROLATE	glycopyrrolate	General Injectables and Vaccines, Inc.	ANDA	Current
52584-396	GLYCOPYRROLATE	glycopyrrolate	General Injectables and Vaccines, Inc.	ANDA	Current
52584-396	GLYCOPYRROLATE	glycopyrrolate	General Injectables and Vaccines, Inc.	ANDA	Current
52584-396	GLYCOPYRROLATE	glycopyrrolate	General Injectables and Vaccines, Inc.	ANDA	Current
52584-396	GLYCOPYRROLATE	glycopyrrolate	General Injectables and Vaccines, Inc.	ANDA	Current
52584-396	GLYCOPYRROLATE	glycopyrrolate	General Injectables and Vaccines, Inc.	ANDA	Current
55154-8225	Glycopyrrolate	Glycopyrrolate	Cardinal Health 107, LLC	ANDA	Current
55154-8225	Glycopyrrolate	Glycopyrrolate	Cardinal Health	ANDA	Current
68001-351	Glycopyrrolate	Glycopyrrolate	BluePoint Laboratories	ANDA	Current
68001-351	Glycopyrrolate	Glycopyrrolate	BluePoint Laboratories	ANDA	Current
68001-352	Glycopyrrolate	Glycopyrrolate	BluePoint Laboratories	ANDA	Current
68001-352	Glycopyrrolate	Glycopyrrolate	BluePoint Laboratories	ANDA	Current
68001-353	Glycopyrrolate	Glycopyrrolate	BluePoint Laboratories	ANDA	Current
68001-353	Glycopyrrolate	Glycopyrrolate	BluePoint Laboratories	ANDA	Current
68001-354	Glycopyrrolate	Glycopyrrolate	BluePoint Laboratories	ANDA	Current
68001-354	Glycopyrrolate	Glycopyrrolate	BluePoint Laboratories	ANDA	Current
70121-1394	Glycopyrrolate	Glycopyrrolate	Amneal Pharmaceuticals LLC	ANDA	Current
70121-1394	Glycopyrrolate	Glycopyrrolate	Amneal Pharmaceuticals LLC	ANDA	Current
70121-1394	Glycopyrrolate	Glycopyrrolate	Amneal Pharmaceuticals LLC	ANDA	Current
70121-1394	Glycopyrrolate	Glycopyrrolate	Amneal Biosciences	ANDA	Current
70121-1394	Glycopyrrolate	Glycopyrrolate	Amneal Biosciences LLC	ANDA	Current
70121-1395	Glycopyrrolate	Glycopyrrolate	Amneal Pharmaceuticals LLC	ANDA	Current
70121-1395	Glycopyrrolate	Glycopyrrolate	Amneal Pharmaceuticals LLC	ANDA	Current
70121-1395	Glycopyrrolate	Glycopyrrolate	Amneal Pharmaceuticals LLC	ANDA	Current
70121-1395	Glycopyrrolate	Glycopyrrolate	Amneal Biosciences	ANDA	Current
70121-1395	Glycopyrrolate	Glycopyrrolate	Amneal Biosciences LLC	ANDA	Current
70121-1396	Glycopyrrolate	Glycopyrrolate	Amneal Pharmaceuticals LLC	ANDA	Current
70121-1396	Glycopyrrolate	Glycopyrrolate	Amneal Pharmaceuticals LLC	ANDA	Current
70121-1396	Glycopyrrolate	Glycopyrrolate	Amneal Pharmaceuticals LLC	ANDA	Current
70121-1396	Glycopyrrolate	Glycopyrrolate	Amneal Biosciences	ANDA	Current
70121-1396	Glycopyrrolate	Glycopyrrolate	Amneal Biosciences LLC	ANDA	Current
70121-1397	Glycopyrrolate	Glycopyrrolate	Amneal Pharmaceuticals LLC	ANDA	Current
70121-1397	Glycopyrrolate	Glycopyrrolate	Amneal Pharmaceuticals LLC	ANDA	Current
70121-1397	Glycopyrrolate	Glycopyrrolate	Amneal Pharmaceuticals LLC	ANDA	Current
70121-1397	Glycopyrrolate	Glycopyrrolate	Amneal Biosciences	ANDA	Current
70121-1397	Glycopyrrolate	Glycopyrrolate	Amneal Biosciences LLC	ANDA	Current
71872-7148	Glycopyrrolate	Glycopyrrolate	Medical Purchasing Solutions, LLC	ANDA	Current
71872-7152	Glycopyrrolate	Glycopyrrolate	Medical Purchasing Solutions, LLC	ANDA	Current
71872-7289	Glycopyrrolate	Glycopyrrolate	Medical Purchasing Solutions, LLC	ANDA	Current