Product: Dicloxacillin Sodium Capsules
Company: Teva and Sandoz
Petition Filer: Aurobindo
Petition Number(s): 2020P-1427
Date of Petition: May 28, 2020
Responding Petitions:
Issue and Implication: Whether FDA can designate a second Reference Standard when the current RS is in limited supply.
Action Requested by Petitioner: The…[Read more]
Product: Impoyz®(clobetasol) Topical Cream
Company: Encore Dermatology
Petition Filer: Encore Dermatology
Petition Number(s): 2020P-1421
Date of Petition: May 27, 2020
Responding Petitions:
Issue and Implication: Whether an ANDA product must have identical ingredients to achieve bioequivalency and safety and efficacy.
Action…[Read more]
Product: Vibramycin®(doxycycline) Injection
Company: Pfizer/Fresenius Kabi
Petition Filer: Hymen Phelps
Petition Number(s): 2020P-1403
Date of Petition: May 20, 2020
Responding Petitions:
Issue and Implication: Whether an ANDA can serve as a Reference List Drug when it contains a non-exception excipient.
Action Requested by…[Read more]
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