CLOMIPHENE CITRATE | A072196 | GRANATA BIO CORP
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Suitability Petition from Appco Pharma LLC FDA-2026-P-3444 · 8 docket documents Appco Pharma LLC filed a suitability petition under section 505(j)(2)(C) of the Federal Food, Drug and Cosmetic Act requesting FDA approval to submit an ANDA for Clomiphene Citrate Tablets in 25 mg and 100 mg strengths, which differ from the reference listed drug CLOMID 50 mg approved to Sanofi Aven | Suitability | 2026-03-31 | Open | Appco Pharma LLC |
Terence J. Mix, Esq. - Citizen Petition FDA-2007-P-0234 · 19 docket documents Terence J. Mix, Esq. filed this citizen petition requesting that the FDA Commissioner order post-market labeling changes to CLOMID (clomiphene citrate) NDA 16-131 and its generic versions to include warnings about teratogenic risks, oversee risk evaluation and mitigation strategies to determine whet | Other | 2008-05-10 | Denied | — |
Source: Regulations.gov. FDA citizen petitions matched by application number.
Highest NADAC/Unit
$5.66
per ea
Lowest NADAC/Unit
$5.66
per ea
Brand NDCs
0
Generic NDCs
2
| NDC Description | NADAC/Unit | Unit | Type | Generic NADAC | Effective |
|---|---|---|---|---|---|
| 35573047030MILOPHENE 50 MG TAB | $5.66 | EA | Generic | — | 2026-06-17 |
| 35573047075MILOPHENE 50 MG TAB | $5.66 | EA | 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.