Home Applications 022571 Application 022571
Type NDA
Sponsor MERZ PHARMS Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 CUVPOSA GLYCOPYRROLATE SOLUTION;ORAL 1MG/5ML Yes Yes
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 N022571-001 CUVPOSA GLYCOPYRROLATE 1MG/5ML SOLUTION / ORAL AA RLD, RS 2010-07-28
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N022571-001 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 N022571-001 CUVPOSA 1MG/5ML SOLUTION / ORAL AA RLD, RS 2010-07-28 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 N022571-001 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 · 1 matching rows.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 7 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0259-0501 Cuvposa glycopyrrolate Merz Pharmaceuticals, LLC NDA Current 0259-0501 Cuvposa glycopyrrolate Merz Pharmaceuticals, LLC NDA Current 0259-0501 Cuvposa glycopyrrolate Merz Pharmaceuticals, LLC NDA Current 0259-0501 Cuvposa glycopyrrolate Merz Pharmaceuticals, LLC NDA Current 0259-0501 Cuvposa glycopyrrolate Merz Pharmaceuticals, LLC NDA Current 0259-0501 Cuvposa glycopyrrolate Merz Pharmaceuticals, LLC NDA Current 0259-0502 Glycopyrrolate Glycopyrrolate Merz Pharmaceuticals, LLC NDA AUTHORIZED GENERIC Current
Documents# Document, Submission type, Date table Document Submission type Date 52718 SUPPL 2018-02-26 52715 SUPPL 2018-02-26 38854 SUPPL 2016-05-20 7555 SUPPL 2016-05-20 7554 SUPPL 2015-11-13 17725 SUPPL 2015-11-12 38853 SUPPL 2013-05-23 7553 SUPPL 2013-05-23 44780 ORIG 2011-02-23 22060 ORIG 2011-02-23 29871 ORIG 2010-08-02 17724 ORIG 2010-07-31