Composition
- Active ingredients
- SUGAMMADEX 500MG/5ML
Strengths and forms
The FDA lists each strength of a product separately; these pages share one label.
- SUGAMMADEX 500MG/5ML · InjectableANDA214311-002 · Tentative approval
- SUGAMMADEX 200MG/2ML · InjectableANDA214311-001 · Tentative approval
- SUGAMMADEX EQ 200MG BASE/2ML (EQ 100MG BASE/ML) · InjectableANDA214319-002 · Tentative approval
- SUGAMMADEX 100MG/1ML · InjectionANDA215260-001 · Tentative approval
- SUGAMMADEX 100MG/ML · InjectionANDA218727-001 · Tentative approval
- SUGAMMADEX 200MG/2ML · InjectableANDA213915-001 · Tentative approval
- SUGAMMADEX 500MG/5ML · InjectableThis page
- SUGAMMADEX 500MG/5ML(100MG/ML) · InjectableANDA214230-002 · Tentative approval
- SUGAMMADEX 200MG/2ML(100MG/ML) · InjectableANDA214230-001 · Tentative approval
Official product information
Drugs@FDA lists the approved labels, letters and reviews for application ANDA213915.
At a glance
- Brand name
- Sugammadex
- Route
- Injection
- Dosage form
- Injectable
- Applicant
- Mylan Pharms Inc
- Status
- Tentative approval
- FDA approval
- 20 Nov 2024
- Application
- ANDA213915-002