FDA approved the original new drug application for ANDROGEL on February 28, 2000, sponsored by BESINS HLTHCARE. FDA has approved 1 efficacy supplement on the application since, the most recent on August 11, 2005.
- Application
- NDA021015
- Sponsor
- BESINS HLTHCARE
- Original approval
- Review
- standard review
- Submission class
- Type 3 - New Dosage Form
- Active ingredient
- testosterone
Browse every approval whose brand starts with A, or the complete response letters FDA has published — the applications it did not approve.
Products under this application
| Ingredient and strength | Form | Route | Marketing status |
|---|---|---|---|
| testosterone 50MG/5GM PACKET | GEL | TRANSDERMAL | Prescription |
| testosterone 12.5MG/1.25GM ACTUATION | GEL, METERED | TRANSDERMAL | Prescription |
| testosterone 25MG/2.5GM PACKET | GEL | TRANSDERMAL | Prescription |
Approved efficacy supplements
An efficacy supplement is how a sponsor asks FDA to approve a change that needs clinical evidence — most often a new indication. FDA’s record gives each one a submission number, a date and a review priority. It does not say what any supplement approved, so neither does this page. The approval letter and label for each are on accessdata.fda.gov under the application number.
| Approved | Supplement | Review |
|---|---|---|
| S-11 | — |
FDA records other approved supplements on this application, by the class code it assigns them: Labeling 21 · Manufacturing (CMC) 9 · REMS 2. Those are changes to the label or to how the drug is made rather than new clinical evidence, so they are counted here and not listed.
Source: FDA’s Drugs@FDA application file, via openFDA (export 2026-09-03). Every field on this page comes from that record.
Other approvals to BESINS HLTHCARE
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