TERBINAFINE | N021958 | KARO HEALTHCARE INC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Attachment 2 - LAMISIL (terbinafine hydrochloride) tablets, for oral use RE S... FDA-2023-P-4333 Hyman, Phelps & McNamara, P.C. filed a suitability petition regarding LAMISIL (terbinafine hydrochloride) tablets for oral use, requesting a determination of the drug's suitability for ANDA purposes to facilitate the approval of generic versions. | Suitability | 2023-10-04 | Denied | Hyman, Phelps & McNamara, P.C. |
Attachment 3 - TERBINAFINE tablets, for oral use RE Suitability Petition from... FDA-2023-P-4333 Hyman, Phelps & McNamara, P.C. filed a citizen petition regarding terbinafine tablets for oral use requesting a determination of suitability, likely under FDA mechanisms governing the approvability or regulatory pathway for generic or abbreviated applications for this antifungal medication. | Suitability | 2023-10-04 | Denied | Hyman, Phelps & McNamara, P.C. |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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