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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 208766
Company: AMNEAL
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ACYCLOVIR ACYCLOVIR 5% CREAM;TOPICAL Prescription AB No No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
11/09/2020 ORIG-1 Approval STANDARD

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
11/01/2021 SUPPL-2 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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