OXANDROLONE | A077827 | PAR PHARMACEUTICAL INC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Novitium Pharma LLC FDA-2019-P-3907 Novitium Pharma LLC filed this citizen petition under 21 CFR § 10.30 requesting that the FDA designate the generic product made by PAR Pharmaceutical Inc (ANDA A077827) as the reference standard for Oxandrin (oxandrolone) Tablets 2.5mg and 10mg (NDA 013718), since the brand manufacturer Gemini Labor | 505(q) | 2019-08-20 | Denied | Novitium Pharma LLC |
Citizen Petition from Novitium Pharma LLC FDA-2019-P-1980 Novitium Pharma LLC filed this citizen petition under 21 C.F.R. § 10.30 requesting that the FDA designate PAR Pharmaceutical Inc's generic product (ANDA A077827) as the reference standard for Oxandrin (Oxandrolone) Tablets 2.5mg and 10mg (NDA 013718), since the original brand manufacturer Gemini Lab | Other | 2019-04-25 | Denied | Novitium Pharma LLC |
Citizen Petition from Novitium Pharma LLC. FDA-2018-P-3422 Novitium Pharma LLC filed this citizen petition under 21 CFR 10.30 requesting that the FDA designate PAR Pharmaceutical Inc's generic product (ANDA A077827) as the reference standard for Oxandrin (Oxandrolone) Tablets 2.5mg and 10mg (NDA 013718), because the original brand manufacturer Gemini Labora | 505(q) | 2018-09-10 | Withdrawn | Novitium Pharma LLC. |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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