TESTOSTERONE | N021015 | BESINS HEALTHCARE IRELAND LTD
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Abbott Laboratories (Mayer Brown, LLP) - Citizen Petition FDA-2011-P-0610 · 8 docket documents Abbott Laboratories, represented by Mayer Brown LLP, filed this citizen petition on August 18, 2011, requesting that the FDA refrain from granting a therapeutic equivalence rating to any new drug submitted under section 505(b)(2) that references AndroGel (testosterone gel) until FDA conducts a notic | 505(q) Stay Request | 2011-09-01 | Partially Denied | — |
Hogan & Hartson, LLP (Abbott Laboratories) - Citizen Petition FDA-2010-P-0196 · 6 docket documents Hogan & Hartson, LLP, on behalf of Abbott Laboratories, submitted this citizen petition under 21 U.S.C. §§ 355(b) and 355(q) requesting that FDA require any applicant seeking to reference Abbott's AndroGel (testosterone gel) with different penetration enhancers than the reference product to conduct | 505(q) | 2010-04-26 | Partially Denied | — |
Source: Regulations.gov. FDA citizen petitions matched by application number.
Highest NADAC/Unit
$1.13
per gm
Lowest NADAC/Unit
$0.4143
per gm
Brand NDCs
0
Generic NDCs
3
| NDC Description | NADAC/Unit | Unit | Type | Generic NADAC | Effective |
|---|---|---|---|---|---|
| 66993095430TESTOSTERONE 1% (25 MG/2.5 G) PK | $1.13 | GM | Generic | — | 2026-06-17 |
| 66993095344TESTOSTERONE 12.5 MG/1.25 GRAM | $0.6456 | GM | Generic | — | 2026-06-17 |
| 66993095530TESTOSTERONE 1% (50 MG/5 G) PK | $0.4143 | GM | Generic | — | 2026-06-17 |
Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.
No patent or exclusivity listings for this strength.