ACYCLOVIR | N019909 | PHARMOBEDIENT CONSULTING LLC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Pitney, Hardin, Kipp & Szuch FDA-1996-P-0034 · 7 docket documents The law firm Pitney, Hardin, Kipp & Szuch filed this citizen petition pursuant to 21 CFR 314.93 requesting that the FDA permit the filing of an Abbreviated New Drug Application for Acyclovir Cream, 5%, which differs from the listed drug Zovirax Ointment, 5% only in dosage form, with the petitioner a | Other | 2017-12-26 | Granted | Pitney, Hardin, Kipp & Szuch |
Citizen Petition from Yiling Pharmaceutical, Ltd FDA-2017-P-2043 · 6 docket documents Yiling Pharmaceutical Ltd filed this citizen petition under 21 CFR 10.25(a) and 10.30 requesting that the FDA select a different listed drug as the reference standard for ZOVIRAX (Acyclovir) Capsules 200mg for ANDA submissions, citing that the current reference standard from Mylan Pharmaceuticals In | 505(q) | 2017-04-03 | Granted | Yiling Pharmaceutical, Ltd |
Paddock Laboratories, Inc., (Winston & Strawn LLP) - Citizen Petition FDA-2011-P-0486 · 4 docket documents Paddock Laboratories, Inc. filed a citizen petition on June 10, 2011, seeking paragraph IV patent certifications for numerous generic drug products including abacavir sulfate, various combination antiretroviral therapies, acyclovir sodium, albuterol sulfate formulations, alendronate sodium, and many | Other | 2011-07-19 | Granted | — |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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