FDA
Glatiramer Acetate
The FDA lists this product in 10 strengths and forms.
Composition
- Active ingredients
- GLATIRAMER ACETATE 40MG/ML
Strengths and forms
The FDA lists each strength of a product separately; these pages share one label.
- GLATIRAMER ACETATE 40MG/ML · InjectableANDA206936-001 · Prescription
- GLATIRAMER ACETATE 40MG/ML · InjectableANDA214022-001 · Prescription
- GLATIRAMER ACETATE 20MG/ML · InjectableANDA203857-001 · Prescription
- GLATIRAMER ACETATE 40MG/ML · InjectableANDA208468-002 · Prescription
- GLATIRAMER ACETATE 20MG/ML · InjectableANDA208468-001 · Prescription
- GLATIRAMER ACETATE 20MG/ML · InjectableANDA091646-001 · Prescription
- GLATIRAMER ACETATE 20MG/ML · InjectableANDA213382-001 · Prescription
- GLATIRAMER ACETATE 20MG/ML · InjectableANDA214741-001 · Prescription
- GLATIRAMER ACETATE 40MG/ML · InjectableANDA214741-002 · Prescription
- GLATIRAMER ACETATE 40MG/ML · InjectableThis page
Official product information
Drugs@FDA lists the approved labels, letters and reviews for application ANDA206873.
At a glance
- Brand name
- Glatiramer Acetate
- Route
- Subcutaneous
- Dosage form
- Injectable
- Applicant
- Synthon Pharms Inc
- Status
- Prescription
- FDA approval
- 25 Sept 2024
- Application
- ANDA206873-001