FDA Approvals | Biologic
Fixture preamble for the FDA approvals landing page.
Top 5 innovator ingredients
- None
Top 5 generic ingredients
- Fixtimab (1)
Top 5 innovator sponsors
- None
Top 5 generic sponsors
Note: these approvals are sourced from Drugs@FDA and Purple Book, and do not currently reflect older FDA approvals and/or other evidence of US marketing.
Active Ingredients
| Active Ingredient | Innovator Sponsor | Approval Years | Innovator Years | Innovator | Generic | Type |
|---|---|---|---|---|---|---|
| Fixtimab | — | 2021 | — | 0 | 1 | Biologic |
1 ingredients
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Sponsor Organizations
| Sponsor | Approval Years | Innovator Years | Innovator | Generic | Org Type |
|---|
Approval Applications
| Appl No | Type | Approval | Sponsor | Active Ingredients | Marketing Status | Class | Priority? | Links |
|---|
Submission class glossary
- TYPE 1
- New Molecular Entity
- TYPE 2
- New Active Ingredient
- TYPE 3
- New Dosage Form
- TYPE 4
- New Combination
- TYPE 5
- New Formulation or New Manufacturer
- TYPE 6
- New Indication (pre-2009)
- TYPE 7
- Drug Already Marketed without Approved NDA
- TYPE 8
- Partial Rx to OTC Switch
- TYPE 9
- New Indication or Claim (existing NDA)
- TYPE 10
- New Indication or Claim (additional NDA)
- MEDGAS
- Medical Gas