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 42 .
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.
Product history page 1 of 2 · 42 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 2026-08-18 06:07:40 2026-07 N022571-001 CUVPOSA 1MG/5ML SOLUTION / ORAL AA RLD, RS 2010-07-28 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N022571-001 CUVPOSA 1MG/5ML SOLUTION / ORAL AA RLD, RS 2010-07-28 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022571-001 CUVPOSA 1MG/5ML SOLUTION / ORAL AA RLD, RS 2010-07-28 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N022571-001 CUVPOSA 1MG/5ML SOLUTION / ORAL AA RLD, RS 2010-07-28 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022571-001 CUVPOSA 1MG/5ML SOLUTION / ORAL AA RLD, RS 2010-07-28 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022571-001 CUVPOSA 1MG/5ML SOLUTION / ORAL AA RLD, RS 2010-07-28 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022571-001 CUVPOSA 1MG/5ML SOLUTION / ORAL AA RLD, RS 2010-07-28 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022571-001 CUVPOSA 1MG/5ML SOLUTION / ORAL AA RLD, RS 2010-07-28 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022571-001 CUVPOSA 1MG/5ML SOLUTION / ORAL AA RLD, RS 2010-07-28 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N022571-001 CUVPOSA 1MG/5ML SOLUTION / ORAL AA RLD, RS 2010-07-28 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N022571-001 CUVPOSA 1MG/5ML SOLUTION / ORAL AA RLD, RS 2010-07-28 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N022571-001 CUVPOSA 1MG/5ML SOLUTION / ORAL AA RLD, RS 2010-07-28 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N022571-001 CUVPOSA 1MG/5ML SOLUTION / ORAL AA RLD, RS 2010-07-28 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N022571-001 CUVPOSA 1MG/5ML SOLUTION / ORAL AA RLD, RS 2010-07-28 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N022571-001 CUVPOSA 1MG/5ML SOLUTION / ORAL AA RLD, RS 2010-07-28 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022571-001 CUVPOSA 1MG/5ML SOLUTION / ORAL AA RLD, RS 2010-07-28 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N022571-001 CUVPOSA 1MG/5ML SOLUTION / ORAL AA RLD, RS 2010-07-28 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N022571-001 CUVPOSA 1MG/5ML SOLUTION / ORAL AA RLD, RS 2010-07-28 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N022571-001 CUVPOSA 1MG/5ML SOLUTION / ORAL RLD, RS 2010-07-28 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N022571-001 CUVPOSA 1MG/5ML SOLUTION / ORAL AA RLD, RS 2010-07-28 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N022571-001 CUVPOSA 1MG/5ML SOLUTION / ORAL AA RLD, RS 2010-07-28 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N022571-001 CUVPOSA 1MG/5ML SOLUTION / ORAL RLD, RS 2010-07-28 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N022571-001 CUVPOSA 1MG/5ML SOLUTION / ORAL RLD, RS 2010-07-28 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N022571-001 CUVPOSA 1MG/5ML SOLUTION / ORAL RLD, RS 2010-07-28 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N022571-001 CUVPOSA 1MG/5ML SOLUTION / ORAL RLD, RS 2010-07-28 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N022571-001 CUVPOSA 1MG/5ML SOLUTION / ORAL RLD, RS 2010-07-28 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N022571-001 CUVPOSA 1MG/5ML SOLUTION / ORAL RLD, RS 2010-07-28 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N022571-001 CUVPOSA 1MG/5ML SOLUTION / ORAL RLD, RS 2010-07-28 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N022571-001 CUVPOSA 1MG/5ML SOLUTION / ORAL AA RLD, RS 2010-07-28 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N022571-001 CUVPOSA 1MG/5ML SOLUTION / ORAL AA RLD, RS 2010-07-28 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N022571-001 CUVPOSA 1MG/5ML SOLUTION / ORAL AA RLD, RS 2010-07-28 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N022571-001 CUVPOSA 1MG/5ML SOLUTION / ORAL AA RLD, RS 2010-07-28 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N022571-001 CUVPOSA 1MG/5ML SOLUTION / ORAL AA RLD, RS 2010-07-28 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N022571-001 CUVPOSA 1MG/5ML SOLUTION / ORAL AA RLD, RS 2010-07-28 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N022571-001 CUVPOSA 1MG/5ML SOLUTION / ORAL AA RLD, RS 2010-07-28 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N022571-001 CUVPOSA 1MG/5ML SOLUTION / ORAL AA RLD, RS 2010-07-28 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N022571-001 CUVPOSA 1MG/5ML SOLUTION / ORAL AA RLD, RS 2010-07-28 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N022571-001 CUVPOSA 1MG/5ML SOLUTION / ORAL AA RLD, RS 2010-07-28 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N022571-001 CUVPOSA 1MG/5ML SOLUTION / ORAL AA RLD, RS 2010-07-28 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N022571-001 CUVPOSA 1MG/5ML SOLUTION / ORAL AA RLD, RS 2010-07-28 e64feba35796…
Observed Orange Book normalized TE history# Observed Orange Book patent history# Patent history page 1 of 2 · 48 observed states.
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 · 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