Orange Book product · Brand (NDA)
ROBINUL
GLYCOPYRROLATE
At a glance
Approved Prior to Jan 1, 1982
Approved
Brand (NDA)
Application
AA
TE code
None
Listed patents
Key dates
No patent or exclusivity dates are listed for this product.
Pharmaceutical detail
Active ingredient
GLYCOPYRROLATE
Strength
1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage form
TABLET
Route
ORAL
TE code
AA
Application
NDA 012827
Product number
001
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
No
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
- 2010CUVPOSABrand (NDA)
NDA 022571 · MERZ PHARMS
- —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
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.
