Application 202675

Type: ANDA
Sponsor: AUROLIFE PHARMA LLC

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
A202675-001	GLYCOPYRROLATE	GLYCOPYRROLATE	1MG	TABLET / ORAL	AA		2013-04-15
A202675-002	GLYCOPYRROLATE	GLYCOPYRROLATE	2MG	TABLET / ORAL	AA		2018-10-30

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A202675-001	AA
A202675-002	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.

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
2026-08-01 22:54:32	2026-06	A202675-001	GLYCOPYRROLATE	1MG	TABLET / ORAL	AA		2013-04-15	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A202675-002	GLYCOPYRROLATE	2MG	TABLET / ORAL	AA		2018-10-30	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-01 22:54:32	2026-06	A202675-001	AA	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A202675-002	AA	1	`a50c72e98297…`

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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	REMEDYREPACK INC.	220cd5f5-3d71-4fdb-9943-7468799c179f	2026-06-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202675 application number: ANDA202675
GLYCOPYRROLATE	GLYCOPYRROLATE	Bryant Ranch Prepack	098c7654-a352-47ee-bf23-6a81f8601266	2026-05-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202675 application number: ANDA202675
GLYCOPYRROLATE	GLYCOPYRROLATE	Bryant Ranch Prepack	21c7d201-c0b8-4f16-be4a-681d0b22791e	2026-04-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202675 application number: ANDA202675 ndc (product): 63629-7207
GLYCOPYRROLATE	GLYCOPYRROLATE	NCS HealthCare of KY, LLC dba Vangard Labs	5ed930b7-a36e-4bf8-b1d1-dad238d3dd18	2026-02-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202675 application number: ANDA202675
GLYCOPYRROLATE	GLYCOPYRROLATE	Aurolife Pharma LLC	677f8495-a870-45b6-bb65-75b449f040ce	2025-12-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202675 application number: ANDA202675 ndc (product): 13107-014 ndc (product): 13107-015
GLYCOPYRROLATE	GLYCOPYRROLATE	American Health Packaging	6404fc8e-d109-4950-9dca-c8a85ad90cf3	2025-05-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202675 application number: ANDA202675 ndc (product): 60687-458
Glycopyrrolate	GLYCOPYRROLATE	AvPAK	bd497783-e2d1-130c-e053-2995a90a7fb9	2025-03-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202675 application number: ANDA202675 ndc (product): 50268-363

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 10 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
13107-014	Glycopyrrolate	Glycopyrrolate	Aurolife Pharma, LLC	ANDA	Current
13107-014	Glycopyrrolate	Glycopyrrolate	Aurolife Pharma, LLC	ANDA	Current
13107-015	Glycopyrrolate	Glycopyrrolate	Aurolife Pharma, LLC	ANDA	Current
13107-015	Glycopyrrolate	Glycopyrrolate	Aurolife Pharma, LLC	ANDA	Current
50268-363	Glycopyrrolate	Glycopyrrolate	AvPAK	ANDA	Current
50268-363	Glycopyrrolate	Glycopyrrolate	AvPAK	ANDA	Current
60687-458	Glycopyrrolate	Glycopyrrolate	American Health Packaging	ANDA	Current
60687-458	Glycopyrrolate	Glycopyrrolate	American Health Packaging	ANDA	Current
63629-7207	Glycopyrrolate	Glycopyrrolate	Bryant Ranch Prepack	ANDA	Current
63629-7207	Glycopyrrolate	Glycopyrrolate	Bryant Ranch Prepack	ANDA	Current