Orange Book product · Generic (ANDA)
GLYCOPYRROLATE
GLYCOPYRROLATE
At a glance
Feb 21, 2020
Approved
Generic (ANDA)
Application
AP
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Feb 21, 2020
6 yr 5 mo ago
Today
Pharmaceutical detail
Active ingredient
GLYCOPYRROLATE
Strength
0.2MG/ML
Dosage form
INJECTABLE
Route
INJECTION
TE code
AP
Application
ANDA 210083
Product number
001
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of GLYCOPYRROLATE
- 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.
