Application 091413

Type: ANDA
Sponsor: NATCO PHARMA LTD

Application Products#

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

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
A091413-001	GLYCOPYRROLATE	GLYCOPYRROLATE	1MG	TABLET / ORAL	AA		2016-06-20
A091413-002	GLYCOPYRROLATE	GLYCOPYRROLATE	2MG	TABLET / ORAL	AA		2016-06-20

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A091413-001	AA
A091413-002	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 1 of 3 · 86 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
2026-09-14 22:38:34	2026-08	A091413-001	GLYCOPYRROLATE	1MG	TABLET / ORAL	AA	2016-06-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A091413-002	GLYCOPYRROLATE	2MG	TABLET / ORAL	AA	2016-06-20	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A091413-001	GLYCOPYRROLATE	1MG	TABLET / ORAL	AA	2016-06-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A091413-002	GLYCOPYRROLATE	2MG	TABLET / ORAL	AA	2016-06-20	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A091413-001	GLYCOPYRROLATE	1MG	TABLET / ORAL	AA	2016-06-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091413-002	GLYCOPYRROLATE	2MG	TABLET / ORAL	AA	2016-06-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091413-001	GLYCOPYRROLATE	1MG	TABLET / ORAL	AA	2016-06-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091413-002	GLYCOPYRROLATE	2MG	TABLET / ORAL	AA	2016-06-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091413-001	GLYCOPYRROLATE	1MG	TABLET / ORAL	AA	2016-06-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091413-002	GLYCOPYRROLATE	2MG	TABLET / ORAL	AA	2016-06-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091413-001	GLYCOPYRROLATE	1MG	TABLET / ORAL	AA	2016-06-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091413-002	GLYCOPYRROLATE	2MG	TABLET / ORAL	AA	2016-06-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091413-001	GLYCOPYRROLATE	1MG	TABLET / ORAL	AA	2016-06-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091413-002	GLYCOPYRROLATE	2MG	TABLET / ORAL	AA	2016-06-20	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091413-001	GLYCOPYRROLATE	1MG	TABLET / ORAL	AA	2016-06-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091413-002	GLYCOPYRROLATE	2MG	TABLET / ORAL	AA	2016-06-20	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091413-001	GLYCOPYRROLATE	1MG	TABLET / ORAL	AA	2016-06-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091413-002	GLYCOPYRROLATE	2MG	TABLET / ORAL	AA	2016-06-20	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091413-001	GLYCOPYRROLATE	1MG	TABLET / ORAL	AA	2016-06-20	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091413-002	GLYCOPYRROLATE	2MG	TABLET / ORAL	AA	2016-06-20	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091413-001	GLYCOPYRROLATE	1MG	TABLET / ORAL	AA	2016-06-20	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091413-002	GLYCOPYRROLATE	2MG	TABLET / ORAL	AA	2016-06-20	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091413-001	GLYCOPYRROLATE	1MG	TABLET / ORAL	AA	2016-06-20	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091413-002	GLYCOPYRROLATE	2MG	TABLET / ORAL	AA	2016-06-20	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091413-001	GLYCOPYRROLATE	1MG	TABLET / ORAL	AA	2016-06-20	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091413-002	GLYCOPYRROLATE	2MG	TABLET / ORAL	AA	2016-06-20	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091413-001	GLYCOPYRROLATE	1MG	TABLET / ORAL	AA	2016-06-20	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091413-002	GLYCOPYRROLATE	2MG	TABLET / ORAL	AA	2016-06-20	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091413-001	GLYCOPYRROLATE	1MG	TABLET / ORAL	AA	2016-06-20	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091413-002	GLYCOPYRROLATE	2MG	TABLET / ORAL	AA	2016-06-20	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091413-001	GLYCOPYRROLATE	1MG	TABLET / ORAL	AA	2016-06-20	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A091413-002	GLYCOPYRROLATE	2MG	TABLET / ORAL	AA	2016-06-20	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091413-001	GLYCOPYRROLATE	1MG	TABLET / ORAL	AA	2016-06-20	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091413-002	GLYCOPYRROLATE	2MG	TABLET / ORAL	AA	2016-06-20	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091413-001	GLYCOPYRROLATE	1MG	TABLET / ORAL	AA	2016-06-20	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A091413-002	GLYCOPYRROLATE	2MG	TABLET / ORAL	AA	2016-06-20	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091413-001	GLYCOPYRROLATE	1MG	TABLET / ORAL	AA	2016-06-20	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A091413-002	GLYCOPYRROLATE	2MG	TABLET / ORAL	AA	2016-06-20	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A091413-001	GLYCOPYRROLATE	1MG	TABLET / ORAL	AA	2016-06-20	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A091413-002	GLYCOPYRROLATE	2MG	TABLET / ORAL	AA	2016-06-20	`74a2ff9319b5…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 86 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A091413-001	AA	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A091413-002	AA	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A091413-001	AA	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A091413-002	AA	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A091413-001	AA	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091413-002	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091413-001	AA	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091413-002	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091413-001	AA	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091413-002	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091413-001	AA	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091413-002	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091413-001	AA	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091413-002	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091413-001	AA	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091413-002	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091413-001	AA	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091413-002	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091413-001	AA	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091413-002	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091413-001	AA	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091413-002	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091413-001	AA	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091413-002	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091413-001	AA	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091413-002	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091413-001	AA	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091413-002	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091413-001	AA	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091413-002	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091413-001	AA	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A091413-002	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091413-001	AA	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091413-002	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091413-001	AA	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A091413-002	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091413-001	AA	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A091413-002	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A091413-001	AA	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A091413-002	AA	1	`74a2ff9319b5…`

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 5 of 6 · 115 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Glycopyrrolate	GLYCOPYRROLATE	Fresenius Kabi USA, LLC	54458620-d888-4df6-ae4b-78c3dfed3423	2023-08-16	Warnings, Adverse reactions	Name fallback brand name: Glycopyrrolate generic name: GLYCOPYRROLATE
Glycopyrrolate	GLYCOPYRROLATE	Fresenius Kabi USA, LLC	88d3e865-8dca-4c89-b6f7-a34c481f75b9	2023-08-16	Warnings, Adverse reactions	Name fallback brand name: Glycopyrrolate generic name: GLYCOPYRROLATE
GLYCOPYRROLATE	GLYCOPYRROLATE	Bryant Ranch Prepack	4c733750-45fe-4876-8e4f-c61c52470405	2023-06-06	Warnings, Adverse reactions	Name fallback brand name: GLYCOPYRROLATE generic name: GLYCOPYRROLATE
Glycopyrrolate	GLYCOPYRROLATE	Medical Purchasing Solutions, LLC	86abf577-562c-5eb1-e053-2a91aa0ac10f	2023-06-01	Warnings, Adverse reactions	Name fallback brand name: Glycopyrrolate generic name: GLYCOPYRROLATE
Glycopyrrolate	GLYCOPYRROLATE	Medical Purchasing Solutions, LLC	66726c2b-27e8-5dd1-e053-2991aa0a1ba7	2023-06-01	Warnings, Adverse reactions	Name fallback brand name: Glycopyrrolate generic name: GLYCOPYRROLATE
Glycopyrrolate	GLYCOPYRROLATE	Medical Purchasing Solutions, LLC	69353cc1-f5d4-170b-e053-2a91aa0ad5a5	2023-05-23	Warnings, Adverse reactions	Name fallback brand name: Glycopyrrolate generic name: GLYCOPYRROLATE
Glycopyrrolate	GLYCOPYRROLATE	Medical Purchasing Solutions, LLC	6934f467-949f-97cc-e053-2a91aa0a05fb	2023-05-23	Warnings, Adverse reactions	Name fallback brand name: Glycopyrrolate generic name: GLYCOPYRROLATE
Glycopyrrolate	GLYCOPYRROLATE	Medical Purchasing Solutions, LLC	95fbe384-eaff-1f2e-e053-2a95a90a0313	2023-05-15	Warnings, Adverse reactions	Name fallback brand name: Glycopyrrolate generic name: GLYCOPYRROLATE
Glycopyrrolate	GLYCOPYRROLATE	Medical Purchasing Solutions, LLC	8f126596-7fbf-7a48-e053-2995a90abac7	2023-05-15	Warnings, Adverse reactions	Name fallback brand name: Glycopyrrolate generic name: GLYCOPYRROLATE
Glycopyrrolate	GLYCOPYRROLATE	Medical Purchasing Solutions, LLC	8f12016d-9033-00b4-e053-2a95a90ad02a	2023-05-15	Warnings, Adverse reactions	Name fallback brand name: Glycopyrrolate generic name: GLYCOPYRROLATE
Glycopyrrolate	GLYCOPYRROLATE	Medical Purchasing Solutions, LLC	9c9666bf-841b-03fa-e053-2a95a90abb48	2023-05-11	Warnings, Adverse reactions	Name fallback brand name: Glycopyrrolate generic name: GLYCOPYRROLATE
Glycopyrrolate	GLYCOPYRROLATE	Medical Purchasing Solutions, LLC	9e5113b7-1c0c-24bd-e053-2995a90ab94b	2023-05-09	Warnings, Adverse reactions	Name fallback brand name: Glycopyrrolate generic name: GLYCOPYRROLATE
Glycopyrrolate	GLYCOPYRROLATE	Medical Purchasing Solutions, LLC	bbf0abe2-8deb-19b2-e053-2a95a90a60a3	2023-05-08	Warnings, Adverse reactions	Name fallback brand name: Glycopyrrolate generic name: GLYCOPYRROLATE
Glycopyrrolate	GLYCOPYRROLATE	Medical Purchasing Solutions, LLC	b622f21f-fa37-1259-e053-2995a90aa796	2023-05-04	Warnings, Adverse reactions	Name fallback brand name: Glycopyrrolate generic name: GLYCOPYRROLATE
GLYCOPYRROLATE	GLYCOPYRROLATE	Medical Purchasing Solutions, LLC	a2a2a03f-21cc-5fec-e053-2995a90a84cb	2023-05-03	Warnings, Adverse reactions	Name fallback brand name: GLYCOPYRROLATE generic name: GLYCOPYRROLATE
Glycopyrrolate	GLYCOPYRROLATE	LGM PHARMA SOLUTIONS, LLC	392a969d-1e14-4ad8-835c-a47be4983067	2023-04-27	Warnings, Adverse reactions	Name fallback brand name: Glycopyrrolate generic name: GLYCOPYRROLATE
Glycopyrrolate	GLYCOPYRROLATE	Medical Purchasing Solutions, LLC	e8bb95ed-09f1-fcf1-e053-2a95a90a93e5	2023-04-25	Warnings, Adverse reactions	Name fallback brand name: Glycopyrrolate generic name: GLYCOPYRROLATE
Glycopyrrolate	GLYCOPYRROLATE	Medical Purchasing Solutions, LLC	ea4c8be4-a1e9-5901-e053-2995a90a5e63	2023-04-24	Warnings, Adverse reactions	Name fallback brand name: Glycopyrrolate generic name: GLYCOPYRROLATE
Glycopyrrolate	GLYCOPYRROLATE	Civica, Inc.	3ac4f32f-f5ca-4a6d-9bc7-2672d478b3d4	2023-03-01	Warnings, Adverse reactions	Name fallback brand name: Glycopyrrolate generic name: GLYCOPYRROLATE
Glycopyrrolate	GLYCOPYRROLATE	Meitheal Pharmaceuticals Inc.	02f914a8-2356-4525-91ff-cf0c9e41ba23	2023-01-12	Warnings, Adverse reactions	Name fallback brand name: Glycopyrrolate generic name: GLYCOPYRROLATE

Reported adverse events (FAERS/openFDA)#

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