ESTRADIOL | A086069 | ABBVIE INC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Suitability Petition from Lachman Consulting Services, Inc. FDA-2024-P-3905 · 8 docket documents Lachman Consulting Services, Inc. filed this suitability petition on behalf of a client under FD&C Act Section 505(j)(2)(C) requesting that FDA declare Estradiol Vaginal Inserts in 1 g and 2 g strengths suitable for submission as an ANDA, based on the reference listed drug Estrace Vaginal Cream 0.01 | Suitability | 2024-08-16 | Granted | Lachman Consulting Services, Inc. |
Source: Regulations.gov. FDA citizen petitions matched by application number.
Highest NADAC/Unit
$7.77
per gm
Lowest NADAC/Unit
$0.3888
per gm
Brand NDCs
0
Generic NDCs
1
| NDC Description | NADAC/Unit | Unit | Type | Generic NADAC | Effective |
|---|---|---|---|---|---|
| 00430375414ESTRACE 0.01% CREAM | $7.77 | GM | — | $0.3888 | 2026-06-17 |
| 00093354143ESTRADIOL 0.01% CREAM | $0.3888 | 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.