LANREOTIDE ACETATE | N215395 | INVAGEN PHARMACEUTICALS INC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Hyman, Phelps & McNamara, P.C. (on behalf of InvaGen Ph... FDA-2022-P-0329 · 3 docket documents The law firm Hyman, Phelps & McNamara submitted this citizen petition on behalf of InvaGen Pharmaceuticals, Inc. requesting that the FDA assign a Therapeutic Equivalence Evaluation Code of "AP" in the Orange Book to InvaGen's Lanreotide Injection at three strengths (60 mg/0.2 mL, 90 mg/0.3 mL, and 1 | Other | 2022-03-14 | Withdrawn | InvaGen Pharmaceuticals, Inc. |
Citizen Petition from Ipsen Biopharmaceuticals, Inc. FDA-2019-P-4830 · 36 docket documents Ipsen Biopharmaceuticals, Inc., the sponsor of Somatuline Depot (lanreotide acetate), submitted this citizen petition under 21 USC 355 and 21 CFR 10.30 requesting that the FDA require any abbreviated new drug application for a generic version of Somatuline Depot to include an in vivo bioequivalence | 505(q) | 2019-10-17 | Denied | Ipsen Biopharmaceuticals, Inc. |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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