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Research Criteria and Technical Notes

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Latest updates

Product: Zovirax®(acyclovir) Capsules
Company: Mylan
Petition Filer: Yiling Pharmaceutical
Petition Number(s): 2020P-1072
Date of Petition: March 12, 2020
Responding Petitions: None

Action Requested by Petitioner: The Petitioner asks FDA to determine whether acyclovir capsules 200 mg (NDA 018828) was withdrawn for reasons of safety…[Read more]

Profile picture of gregoryglass 1 week, 6 days ago

Product: B. Braun Medical Injectable Products
Company: B. Braun Medical
Petition Filer: B. Braun Medical
Petition Number(s): 2020P-1065
Date of Petition: March 12, 2020
Responding Petitions:

Issue and Implication: Whether certain 505(b)(2) products merit “A” therapeutic equivalence ratings.

Action Requested by Petitioner: Petitio…[Read more]

Profile picture of gregoryglass 1 week, 6 days ago

Product: Tenex®(guanfacine) Tablets
Company: Promius Pharma
Petition Filer: Unichem
Petition Number(s): 2020P-0813
Date of Petition: March 12, 2020
Responding Petitions: None

Action Requested by Petitioner: The Petitioner asks FDA to determine whether Tenex®(guanfacine) Tablets 1 and 2 mg (NDA 019032) was withdrawn for reasons of s…[Read more]

Profile picture of gregoryglass 1 week, 6 days ago
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