Purple Book product · Interchangeable
Rezvoglar
insulin glargine-aglr
At a glance
Dec 17, 2021
Approved
Interchangeable
License type
Rx
Marketing
No
Patents listed
Key dates
Approval
Approval date of this BLA submission.
Dec 17, 2021
4 yr 6 mo ago
Today
Pharmaceutical detail
Strength
300UNITS/3ML (100UNITS/ML)
Dosage form
Injection
Route
Subcutaneous
Presentation
Autoinjector
Center
CDER
License number
1891
Product number
001
Submission type
Original
Supplement number
Not listed
Change type
Not listed
Reference product family
View full familyBiosimilar of insulin glargine (Lantus)
- 2015ToujeoReference 351(a)
insulin glargine · Sanofi-Aventis U.S. LLC
- 2000LantusReference 351(a)
insulin glargine · Sanofi-Aventis U.S. LLC
- 2020SemgleeReference 351(a)
insulin glargine · Mylan Pharmaceuticals Inc.
- 2015BasaglarReference 351(a)
insulin glargine · Eli Lilly and Company
- 2018ToujeoReference 351(a)
insulin glargine · Sanofi-Aventis U.S. LLC
- 2019BasaglarReference 351(a)
insulin glargine · Eli Lilly and Company
- 2007LantusReference 351(a)
insulin glargine · Sanofi-Aventis U.S. LLC
- 2020SemgleeReference 351(a)
insulin glargine · Mylan Pharmaceuticals Inc.
- 2000LantusReference 351(a)
insulin glargine · Sanofi-Aventis U.S. LLC
- 2000LantusReference 351(a)
insulin glargine · Sanofi-Aventis U.S. LLC
Patent list
No patent-list records were published for this product. The Purple Book patent list reflects the statutory patent exchange under the BPCIA and is not exhaustive.
Taxonomy and ontology
11 termscenter
Center for Drug Evaluation and Research
center · CDER
application pathway
Biologics License Application
blaNumber · BLA
license type
351(k) Interchangeable
blaType · 351(k) Interchangeable
application pathway
Section 351(k) Biosimilar or Interchangeable
blaType · 351(k)
product role
Interchangeable Biologic
blaType · Interchangeable
marketing status
Prescription
marketingStatus · Rx
licensure status
Licensed
licensure · Licensed
route
Subcutaneous
routeOfAdministration · Subcutaneous
dosage form
Injection
dosageForm · Injection
source kind
Monthly Download
sourceKind · monthly_download
- Food and Drug Administrationparent ofCenter for Drug Evaluation and Research
- Food and Drug Administrationsource forMonthly Download
- Biologics License Applicationparent ofSection 351(a) Biologic
- Biologics License Applicationparent ofSection 351(k) Biosimilar or Interchangeable
- Section 351(k) Biosimilar or Interchangeablemaps to351(k) Biosimilar
- Section 351(k) Biosimilar or Interchangeablemaps to351(k) Interchangeable
Source provenance
