Orange Book product · Brand (NDA)
CUVPOSA
GLYCOPYRROLATE
At a glance
Jul 28, 2010
Approved
Brand (NDA)
Application
AA
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jul 28, 2010
16 yr 2 mo ago
Today
Pharmaceutical detail
Active ingredient
GLYCOPYRROLATE
Strength
1MG/5ML
Dosage form
SOLUTION
Route
ORAL
TE code
AA
Application
NDA 022571
Product number
001
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
Yes
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
- 2023DARTISLA ODTBrand (NDA)
NDA 215019 · EDENBRIDGE PHARMS
- 2022GLYCOPYRROLATEBrand (NDA)
NDA 214919 · FRESENIUS KABI USA
- 2018GLYRX-PFBrand (NDA)
NDA 210997 · EXELA PHARMA
- 2017LONHALA MAGNAIR KITBrand (NDA)
NDA 208437 · SUMITOMO PHARMA AM
- 2015SEEBRI NEOHALERBrand (NDA)
NDA 207923 · NOVARTIS
- —ROBINULBrand (NDA)
NDA 017558 · HIKMA
- —ROBINULBrand (NDA)
NDA 014764 · ROBINS AH
- 2026GLYCOPYRROLATEGeneric (ANDA)
ANDA 216910 · QUAGEN
- 2025GLYCOPYRROLATEGeneric (ANDA)
ANDA 220062 · BIONPHARMA
- 2025GLYCOPYRROLATEGeneric (ANDA)
ANDA 219267 · AJENAT PHARMS
- 2025GLYCOPYRROLATEGeneric (ANDA)
ANDA 216084 · MSN
- 2024GLYCOPYRROLATEGeneric (ANDA)
ANDA 214847 · AUROBINDO PHARMA LTD
Listed patents
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
