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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 206633
Company: FOUGERA PHARMS INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ACYCLOVIR ACYCLOVIR 5% OINTMENT;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
05/11/2016 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
02/28/2017 SUPPL-1 Labeling-Package Insert, Labeling-Container/Carton Labels

Label is not available on this site.

ACYCLOVIR

OINTMENT;TOPICAL; 5%
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ACYCLOVIR ACYCLOVIR 5% OINTMENT;TOPICAL Prescription No AB 209000 ALEMBIC PHARMS LTD
ACYCLOVIR ACYCLOVIR 5% OINTMENT;TOPICAL Prescription No AB 204605 AMNEAL PHARMS
ACYCLOVIR ACYCLOVIR 5% OINTMENT;TOPICAL Prescription No AB 210774 APOTEX
ACYCLOVIR ACYCLOVIR 5% OINTMENT;TOPICAL Prescription No AB 205974 CADILA
ACYCLOVIR ACYCLOVIR 5% OINTMENT;TOPICAL Prescription No AB 211794 CIPLA
ACYCLOVIR ACYCLOVIR 5% OINTMENT;TOPICAL Prescription No AB 205591 COSETTE
ACYCLOVIR ACYCLOVIR 5% OINTMENT;TOPICAL Prescription No AB 206633 FOUGERA PHARMS INC
ACYCLOVIR ACYCLOVIR 5% OINTMENT;TOPICAL Prescription No AB 205510 GLENMARK PHARMS SA
ACYCLOVIR ACYCLOVIR 5% OINTMENT;TOPICAL Prescription No AB 212444 MACLEODS PHARMS LTD
ACYCLOVIR ACYCLOVIR 5% OINTMENT;TOPICAL Prescription No AB 202459 MYLAN PHARMS INC
ACYCLOVIR ACYCLOVIR 5% OINTMENT;TOPICAL Prescription No AB 212495 SOLARIS PHARMA CORP
ACYCLOVIR ACYCLOVIR 5% OINTMENT;TOPICAL Prescription No AB 205469 TARO
ACYCLOVIR ACYCLOVIR 5% OINTMENT;TOPICAL Prescription No AB 209971 TORRENT
ACYCLOVIR ACYCLOVIR 5% OINTMENT;TOPICAL Prescription No AB 201501 XIROMED
ZOVIRAX ACYCLOVIR 5% OINTMENT;TOPICAL Prescription Yes AB 018604 BAUSCH
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