Application 040653

Type: ANDA
Sponsor: PAR PHARM

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	GLYCOPYRROLATE	GLYCOPYRROLATE	TABLET;ORAL	1MG	No	Yes
002	GLYCOPYRROLATE	GLYCOPYRROLATE	TABLET;ORAL	2MG	No	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A040653-001	GLYCOPYRROLATE	GLYCOPYRROLATE	1MG	TABLET / ORAL	AA	RS	2006-08-31
A040653-002	GLYCOPYRROLATE	GLYCOPYRROLATE	2MG	TABLET / ORAL	AA	RS	2006-08-31

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A040653-001	AA
A040653-002	AA

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 2 of 3 · 86 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2022-03-09 01:35 UTC	2022-03	A040653-001	GLYCOPYRROLATE	1MG	TABLET / ORAL	AA	RS	2006-08-31	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A040653-002	GLYCOPYRROLATE	2MG	TABLET / ORAL	AA	RS	2006-08-31	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040653-001	GLYCOPYRROLATE	1MG	TABLET / ORAL	AA	RS	2006-08-31	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A040653-002	GLYCOPYRROLATE	2MG	TABLET / ORAL	AA	RS	2006-08-31	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040653-001	GLYCOPYRROLATE	1MG	TABLET / ORAL	AA	RS	2006-08-31	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040653-002	GLYCOPYRROLATE	2MG	TABLET / ORAL	AA	RS	2006-08-31	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A040653-001	GLYCOPYRROLATE	1MG	TABLET / ORAL	AA	RS	2006-08-31	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A040653-002	GLYCOPYRROLATE	2MG	TABLET / ORAL	AA	RS	2006-08-31	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040653-001	GLYCOPYRROLATE	1MG	TABLET / ORAL	AA	RS	2006-08-31	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A040653-002	GLYCOPYRROLATE	2MG	TABLET / ORAL	AA	RS	2006-08-31	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A040653-001	GLYCOPYRROLATE	1MG	TABLET / ORAL	AA	RS	2006-08-31	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A040653-002	GLYCOPYRROLATE	2MG	TABLET / ORAL	AA	RS	2006-08-31	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A040653-001	GLYCOPYRROLATE	1MG	TABLET / ORAL	AA	RS	2006-08-31	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A040653-002	GLYCOPYRROLATE	2MG	TABLET / ORAL	AA	RS	2006-08-31	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A040653-001	GLYCOPYRROLATE	1MG	TABLET / ORAL	AA	RS	2006-08-31	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A040653-002	GLYCOPYRROLATE	2MG	TABLET / ORAL	AA	RS	2006-08-31	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A040653-001	GLYCOPYRROLATE	1MG	TABLET / ORAL	AA	RS	2006-08-31	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A040653-002	GLYCOPYRROLATE	2MG	TABLET / ORAL	AA	RS	2006-08-31	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A040653-001	GLYCOPYRROLATE	1MG	TABLET / ORAL	AA	RS	2006-08-31	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A040653-002	GLYCOPYRROLATE	2MG	TABLET / ORAL	AA	RS	2006-08-31	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A040653-001	GLYCOPYRROLATE	1MG	TABLET / ORAL	AA	RS	2006-08-31	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A040653-002	GLYCOPYRROLATE	2MG	TABLET / ORAL	AA	RS	2006-08-31	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A040653-001	GLYCOPYRROLATE	1MG	TABLET / ORAL	AA	RS	2006-08-31	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A040653-002	GLYCOPYRROLATE	2MG	TABLET / ORAL	AA	RS	2006-08-31	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A040653-001	GLYCOPYRROLATE	1MG	TABLET / ORAL	AA	RS	2006-08-31	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A040653-002	GLYCOPYRROLATE	2MG	TABLET / ORAL	AA	RS	2006-08-31	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A040653-001	GLYCOPYRROLATE	1MG	TABLET / ORAL	AA	RS	2006-08-31	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A040653-002	GLYCOPYRROLATE	2MG	TABLET / ORAL	AA	RS	2006-08-31	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A040653-001	GLYCOPYRROLATE	1MG	TABLET / ORAL	AA	RS	2006-08-31	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A040653-002	GLYCOPYRROLATE	2MG	TABLET / ORAL	AA	RS	2006-08-31	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A040653-001	GLYCOPYRROLATE	1MG	TABLET / ORAL	AA	RS	2006-08-31	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A040653-002	GLYCOPYRROLATE	2MG	TABLET / ORAL	AA	RS	2006-08-31	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A040653-001	GLYCOPYRROLATE	1MG	TABLET / ORAL	AA	RS	2006-08-31	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A040653-002	GLYCOPYRROLATE	2MG	TABLET / ORAL	AA	RS	2006-08-31	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A040653-001	GLYCOPYRROLATE	1MG	TABLET / ORAL	AA	RS	2006-08-31	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A040653-002	GLYCOPYRROLATE	2MG	TABLET / ORAL	AA	RS	2006-08-31	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A040653-001	GLYCOPYRROLATE	1MG	TABLET / ORAL	AA	RS	2006-08-31	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A040653-002	GLYCOPYRROLATE	2MG	TABLET / ORAL	AA	RS	2006-08-31	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A040653-001	GLYCOPYRROLATE	1MG	TABLET / ORAL	AA	RS	2006-08-31	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A040653-002	GLYCOPYRROLATE	2MG	TABLET / ORAL	AA	RS	2006-08-31	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Normalized TE history page 2 of 3 · 86 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-03-09 01:35 UTC	2022-03	A040653-001	AA	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A040653-002	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040653-001	AA	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A040653-002	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040653-001	AA	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040653-002	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A040653-001	AA	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A040653-002	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040653-001	AA	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A040653-002	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A040653-001	AA	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A040653-002	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A040653-001	AA	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A040653-002	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A040653-001	AA	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A040653-002	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A040653-001	AA	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A040653-002	AA	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A040653-001	AA	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A040653-002	AA	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A040653-001	AA	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A040653-002	AA	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A040653-001	AA	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A040653-002	AA	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A040653-001	AA	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A040653-002	AA	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A040653-001	AA	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A040653-002	AA	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A040653-001	AA	1	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A040653-002	AA	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A040653-001	AA	1	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A040653-002	AA	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A040653-001	AA	1	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A040653-002	AA	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A040653-001	AA	1	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A040653-002	AA	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A040653-001	AA	1	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A040653-002	AA	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A040653-001	AA	1	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A040653-002	AA	1	`f41ea6bd6efb…`

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	Bryant Ranch Prepack	f7187ddb-ea11-4aa8-8215-a5fcf0f1ca7c	2026-09-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040653 application number: ANDA040653 ndc (product): 63629-2206
Glycopyrrolate	GLYCOPYRROLATE	Par Health USA, LLC	1f266d77-4f9e-44c9-a000-2f8fea3ac80b	2026-07-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040653 application number: ANDA040653 ndc (product): 49884-066 ndc (product): 49884-065
Glycopyrrolate	GLYCOPYRROLATE	Bryant Ranch Prepack	d93a9b2b-708d-4db5-8aae-45fd3a7ca65c	2025-01-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040653 application number: ANDA040653
Glycopyrrolate	GLYCOPYRROLATE	Bryant Ranch Prepack	987ba524-361e-49c3-9e00-550a78748542	2024-10-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040653 application number: ANDA040653 ndc (product): 63629-2207
Glycopyrrolate	GLYCOPYRROLATE	Bryant Ranch Prepack	48a8356e-377e-45ef-a1bf-e9ffec051749	2024-10-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040653 application number: ANDA040653 ndc (product): 63629-9287
Glycopyrrolate	GLYCOPYRROLATE	Bryant Ranch Prepack	fcb295e4-038f-4d4f-8786-4fbcd1d3c298	2024-10-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040653 application number: ANDA040653 ndc (product): 71335-2119
Glycopyrrolate	GLYCOPYRROLATE	Bryant Ranch Prepack	33bbc475-2fe3-48ab-8a9d-56d13053593e	2024-10-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040653 application number: ANDA040653

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 16 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0615-8170	Glycopyrrolate	glycopyrrolate	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
0615-8170	Glycopyrrolate	glycopyrrolate	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
43227-065	Glycopyrrolate	Glycopyrrolate	Par Formulations Private Limited	ANDA	Current
43227-066	Glycopyrrolate	Glycopyrrolate	Par Formulations Private Limited	ANDA	Current
49884-065	Glycopyrrolate	glycopyrrolate	Par Pharmaceutical, Inc.	ANDA	Current
49884-066	Glycopyrrolate	glycopyrrolate	Par Pharmaceutical, Inc.	ANDA	Current
60687-270	Glycopyrrolate	glycopyrrolate	American Health Packaging	ANDA	Current
63629-2206	Glycopyrrolate	glycopyrrolate	Bryant Ranch Prepack	ANDA	Current
63629-2206	Glycopyrrolate	glycopyrrolate	Bryant Ranch Prepack	ANDA	Current
63629-2207	Glycopyrrolate	glycopyrrolate	Bryant Ranch Prepack	ANDA	Current
63629-2207	Glycopyrrolate	glycopyrrolate	Bryant Ranch Prepack	ANDA	Current
63629-5442	Glycopyrrolate	glycopyrrolate	Bryant Ranch Prepack	ANDA	Current
63629-9287	Glycopyrrolate	glycopyrrolate	Bryant Ranch Prepack	ANDA	Current
64980-272	Glycopyrrolate	glycopyrrolate	Rising Pharmaceuticals, Inc.	ANDA	Current
64980-273	Glycopyrrolate	glycopyrrolate	Rising Pharmaceuticals, Inc.	ANDA	Current
71335-2119	Glycopyrrolate	glycopyrrolate	Bryant Ranch Prepack	ANDA	Current