INSULIN ASPART RECOMBINANT | B020986 | NOVO NORDISK INC
Purple Book Patents
No listed patents in Purple Book.
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Lachman Consultant Services Inc FDA-2015-P-2867 Lachman Consultant Services Inc. filed this petition on behalf of a client requesting that the FDA declare Capecitabine Tablets, 300 mg suitable for submission as an abbreviated new drug application under Section 505(j)(2)(C), with Xeloda (capecitabine) Tablets, 500 mg as the reference listed drug. | Other | 2015-08-11 | Withdrawn | Lachman Consultant Services Inc |
Source: Regulations.gov. FDA citizen petitions matched by application number.
No patent or exclusivity listings for this strength.