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Abbreviated New Drug Application (ANDA): 208702
Company: PADAGIS ISRAEL
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ACYCLOVIR ACYCLOVIR 5% CREAM;TOPICAL Prescription AB No Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
02/04/2019 ORIG-1 Approval STANDARD Letter (PDF)
Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/208702Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/208702Orig1s000.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
11/02/2021 SUPPL-2 Labeling-Patient Package Insert, Labeling-Package Insert

Label is not available on this site.

ACYCLOVIR

CREAM;TOPICAL; 5%
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ACYCLOVIR ACYCLOVIR 5% CREAM;TOPICAL Prescription No AB 208766 AMNEAL
ACYCLOVIR ACYCLOVIR 5% CREAM;TOPICAL Prescription No AB 208702 PADAGIS ISRAEL
ZOVIRAX ACYCLOVIR 5% CREAM;TOPICAL Prescription Yes AB 021478 BAUSCH
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