IMATINIB MESYLATE | N219097 | SHORLA ONCOLOGY
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Hyman, Phelps & McNamara, P.C. - Citizen Petition FDA-2010-P-0360 · 9 docket documents Hyman, Phelps & McNamara, P.C., on behalf of a client, submitted this petition pursuant to Section 505(j)(2)(C) of the FDC Act requesting that the FDA determine that Imatinib Mesylate Capsules in strengths of 200 mg, 400 mg, and 600 mg are suitable for submission in an Abbreviated New Drug Applicati | Other | 2010-07-30 | Granted | — |
Hyman Phelps & Mcnamara, P.C, - Citizen Petition FDA-2010-P-0341 · 6 docket documents Hyman, Phelps & McNamara, P.C. filed a citizen petition pursuant to Section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA determine that Imatinib Mesylate Tablets in strengths of 50 mg, 200 mg, and 600 mg are suitable for submission in an Abbreviated New Drug Appli | Other | 2010-06-30 | Granted | — |
Hyman Phelps & McNamara, P.C. - Citizen Petition FDA-2010-P-0275 · 3 docket documents Hyman, Phelps & McNamara, P.C. filed this petition on behalf of a client requesting that the FDA determine whether GLEEVEC imatinib mesylate capsules in 50 mg and 100 mg strengths, approved under NDA No. 21-335 and manufactured by Novartis Pharmaceutical Corp., were voluntarily withdrawn from the ma | 505(q) | 2010-06-14 | Open | — |
Source: Regulations.gov. FDA citizen petitions matched by application number.
| Patent # | Expiration | PED | Drug Substance | Drug Product | Use Code | Delist |
|---|---|---|---|---|---|---|
| 11957681 | Apr 27, 2040 | — | — | Yes | — | — |