Application 207201

Type: ANDA
Sponsor: HERITAGE PHARMS INC

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 1.

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
A207201-001	GLYCOPYRROLATE	GLYCOPYRROLATE	1MG	TABLET / ORAL	AA		2017-01-03
A207201-002	GLYCOPYRROLATE	GLYCOPYRROLATE	2MG	TABLET / ORAL	AA		2017-01-03

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A207201-001	AA
A207201-002	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 · 82 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	A207201-001	GLYCOPYRROLATE	1MG	TABLET / ORAL	AA	2017-01-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207201-002	GLYCOPYRROLATE	2MG	TABLET / ORAL	AA	2017-01-03	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207201-001	GLYCOPYRROLATE	1MG	TABLET / ORAL	AA	2017-01-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207201-002	GLYCOPYRROLATE	2MG	TABLET / ORAL	AA	2017-01-03	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207201-001	GLYCOPYRROLATE	1MG	TABLET / ORAL	AA	2017-01-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207201-002	GLYCOPYRROLATE	2MG	TABLET / ORAL	AA	2017-01-03	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207201-001	GLYCOPYRROLATE	1MG	TABLET / ORAL	AA	2017-01-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207201-002	GLYCOPYRROLATE	2MG	TABLET / ORAL	AA	2017-01-03	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207201-001	GLYCOPYRROLATE	1MG	TABLET / ORAL	AA	2017-01-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207201-002	GLYCOPYRROLATE	2MG	TABLET / ORAL	AA	2017-01-03	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207201-001	GLYCOPYRROLATE	1MG	TABLET / ORAL	AA	2017-01-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207201-002	GLYCOPYRROLATE	2MG	TABLET / ORAL	AA	2017-01-03	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207201-001	GLYCOPYRROLATE	1MG	TABLET / ORAL	AA	2017-01-03	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207201-002	GLYCOPYRROLATE	2MG	TABLET / ORAL	AA	2017-01-03	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207201-001	GLYCOPYRROLATE	1MG	TABLET / ORAL	AA	2017-01-03	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207201-002	GLYCOPYRROLATE	2MG	TABLET / ORAL	AA	2017-01-03	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207201-001	GLYCOPYRROLATE	1MG	TABLET / ORAL	AA	2017-01-03	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207201-002	GLYCOPYRROLATE	2MG	TABLET / ORAL	AA	2017-01-03	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207201-001	GLYCOPYRROLATE	1MG	TABLET / ORAL	AA	2017-01-03	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207201-002	GLYCOPYRROLATE	2MG	TABLET / ORAL	AA	2017-01-03	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207201-001	GLYCOPYRROLATE	1MG	TABLET / ORAL	AA	2017-01-03	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207201-002	GLYCOPYRROLATE	2MG	TABLET / ORAL	AA	2017-01-03	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207201-001	GLYCOPYRROLATE	1MG	TABLET / ORAL	AA	2017-01-03	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207201-002	GLYCOPYRROLATE	2MG	TABLET / ORAL	AA	2017-01-03	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207201-001	GLYCOPYRROLATE	1MG	TABLET / ORAL	AA	2017-01-03	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207201-002	GLYCOPYRROLATE	2MG	TABLET / ORAL	AA	2017-01-03	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207201-001	GLYCOPYRROLATE	1MG	TABLET / ORAL	AA	2017-01-03	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A207201-002	GLYCOPYRROLATE	2MG	TABLET / ORAL	AA	2017-01-03	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207201-001	GLYCOPYRROLATE	1MG	TABLET / ORAL	AA	2017-01-03	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207201-002	GLYCOPYRROLATE	2MG	TABLET / ORAL	AA	2017-01-03	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A207201-001	GLYCOPYRROLATE	1MG	TABLET / ORAL	AA	2017-01-03	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A207201-002	GLYCOPYRROLATE	2MG	TABLET / ORAL	AA	2017-01-03	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A207201-001	GLYCOPYRROLATE	1MG	TABLET / ORAL	AA	2017-01-03	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A207201-002	GLYCOPYRROLATE	2MG	TABLET / ORAL	AA	2017-01-03	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A207201-001	GLYCOPYRROLATE	1MG	TABLET / ORAL	AA	2017-01-03	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A207201-002	GLYCOPYRROLATE	2MG	TABLET / ORAL	AA	2017-01-03	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A207201-001	GLYCOPYRROLATE	1MG	TABLET / ORAL	AA	2017-01-03	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A207201-002	GLYCOPYRROLATE	2MG	TABLET / ORAL	AA	2017-01-03	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A207201-001	GLYCOPYRROLATE	1MG	TABLET / ORAL	AA	2017-01-03	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A207201-002	GLYCOPYRROLATE	2MG	TABLET / ORAL	AA	2017-01-03	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 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	A207201-001	AA	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207201-002	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207201-001	AA	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207201-002	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207201-001	AA	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207201-002	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207201-001	AA	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207201-002	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207201-001	AA	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207201-002	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207201-001	AA	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207201-002	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207201-001	AA	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207201-002	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207201-001	AA	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207201-002	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207201-001	AA	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207201-002	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207201-001	AA	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207201-002	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207201-001	AA	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207201-002	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207201-001	AA	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207201-002	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207201-001	AA	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207201-002	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207201-001	AA	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A207201-002	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207201-001	AA	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207201-002	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A207201-001	AA	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A207201-002	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A207201-001	AA	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A207201-002	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A207201-001	AA	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A207201-002	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A207201-001	AA	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A207201-002	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A207201-001	AA	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A207201-002	AA	1	`782e0a99824c…`

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 · 6 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Glycopyrrolate	GLYCOPYRROLATE	REMEDYREPACK INC.	a338ef22-c243-4075-b02d-bcd5b590104a	2026-03-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207201 application number: ANDA207201
Glycopyrrolate	GLYCOPYRROLATE	REMEDYREPACK INC.	fafea739-87d0-4421-833f-eb066791504c	2026-03-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207201 application number: ANDA207201 ndc (product): 70518-3031
Glycopyrrolate	GLYCOPYRROLATE	Major Pharmaceuticals	6e5bfe6d-d321-4f0f-86e2-457d8fd10a6a	2026-03-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207201 application number: ANDA207201 ndc (product): 0904-6709
Glycopyrrolate	GLYCOPYRROLATE	Chartwell RX, LLC	5773cf63-4006-4d8f-b53b-c84bcfe19e4a	2025-12-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207201 application number: ANDA207201
Glycopyrrolate	GLYCOPYRROLATE	Bryant Ranch Prepack	bfccdb26-5047-4b54-9732-ffac2d78e4d1	2024-05-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207201 application number: ANDA207201 ndc (product): 71335-2075
Glycopyrrolate	GLYCOPYRROLATE	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	26cdd84d-ffa0-4e52-b359-4acef4bd8093	2022-11-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207201 application number: ANDA207201 ndc (product): 23155-607 ndc (product): 23155-606

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 18 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0904-6709	Glycopyrrolate	Glycopyrrolate	Major Pharmaceuticals	ANDA	Current
0904-6709	Glycopyrrolate	Glycopyrrolate	Major Pharmaceuticals	ANDA	Current
0904-6709	Glycopyrrolate	Glycopyrrolate	Major Pharmaceuticals	ANDA	Current
23155-606	Glycopyrrolate	Glycopyrrolate	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	ANDA	Current
23155-606	Glycopyrrolate	Glycopyrrolate	Heritage Pharmaceuticals	ANDA	Current
23155-606	Glycopyrrolate	Glycopyrrolate	HERITAGE PHARMACEUTICALS INC D/B/A AVET PHARMACEUTICALS INC	ANDA	Current
23155-606	Glycopyrrolate	Glycopyrrolate	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	ANDA	Current
23155-606	Glycopyrrolate	Glycopyrrolate	Heritage Pharmaceuticals Inc	ANDA	Current
23155-607	Glycopyrrolate	Glycopyrrolate	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	ANDA	Current
23155-607	Glycopyrrolate	Glycopyrrolate	Heritage Pharmaceuticals	ANDA	Current
23155-607	Glycopyrrolate	Glycopyrrolate	HERITAGE PHARMACEUTICALS INC D/B/A AVET PHARMACEUTICALS INC	ANDA	Current
23155-607	Glycopyrrolate	Glycopyrrolate	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	ANDA	Current
23155-607	Glycopyrrolate	Glycopyrrolate	Heritage Pharmaceuticals Inc	ANDA	Current
70518-3031	Glycopyrrolate	Glycopyrrolate	REMEDYREPACK INC.	ANDA	Current
71335-1458	Glycopyrrolate	Glycopyrrolate	Bryant Ranch Prepack	ANDA	Current
71335-1458	Glycopyrrolate	Glycopyrrolate	Bryant Ranch Prepack	ANDA	Current
71335-1458	Glycopyrrolate	Glycopyrrolate	Bryant Ranch Prepack	ANDA	Current
71335-2075	Glycopyrrolate	Glycopyrrolate	Bryant Ranch Prepack	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
46675	ORIG	2017-01-05