ACYCLOVIR از شرکت MACLEODS PHARMS LTD

ACYCLOVIR از شرکت MACLEODS PHARMS LTD

Abbreviated New Drug Application (ANDA): 212444

Company: MACLEODS PHARMS LTD

Drug NameActive IngredientsStrengthDosage Form/RouteMarketing StatusTE CodeRLDRS
ACYCLOVIRACYCLOVIR5%OINTMENT;TOPICALPrescription

AB

NoNo
Original Approvals or Tentative Approvals
Action DateSubmissionAction TypeSubmission ClassificationReview Priority; Orphan StatusLetters, Reviews, Labels, Patient Package InsertNotesUrl
05/19/2021ORIG-1 Approval

STANDARD

Label is not available on this site.

Supplements
Action DateSubmissionSupplement Categories or Approval TypeLetters, Reviews, Labels, Patient Package InsertNoteUrl
08/05/2021SUPPL-1 Labeling-Container/Carton Labels

Label is not available on this site.

ACYCLOVIR

OINTMENT;TOPICAL; 5%

TE Code = AB

Drug NameActive IngredientsStrengthDosage Form/RouteMarketing StatusRLDTE CodeApplication No.Company
ACYCLOVIRACYCLOVIR5%OINTMENT;TOPICALPrescriptionNoAB209000ALEMBIC PHARMS LTD
ACYCLOVIRACYCLOVIR5%OINTMENT;TOPICALPrescriptionNoAB204605AMNEAL PHARMS
ACYCLOVIRACYCLOVIR5%OINTMENT;TOPICALPrescriptionNoAB210774APOTEX
ACYCLOVIRACYCLOVIR5%OINTMENT;TOPICALPrescriptionNoAB205974CADILA
ACYCLOVIRACYCLOVIR5%OINTMENT;TOPICALPrescriptionNoAB211794CIPLA
ACYCLOVIRACYCLOVIR5%OINTMENT;TOPICALPrescriptionNoAB205591COSETTE
ACYCLOVIRACYCLOVIR5%OINTMENT;TOPICALPrescriptionNoAB206633FOUGERA PHARMS INC
ACYCLOVIRACYCLOVIR5%OINTMENT;TOPICALPrescriptionNoAB205510GLENMARK PHARMS SA
ACYCLOVIRACYCLOVIR5%OINTMENT;TOPICALPrescriptionNoAB212444MACLEODS PHARMS LTD
ACYCLOVIRACYCLOVIR5%OINTMENT;TOPICALPrescriptionNoAB202459MYLAN PHARMS INC
ACYCLOVIRACYCLOVIR5%OINTMENT;TOPICALPrescriptionNoAB212495SOLARIS PHARMA CORP
ACYCLOVIRACYCLOVIR5%OINTMENT;TOPICALPrescriptionNoAB205469TARO
ACYCLOVIRACYCLOVIR5%OINTMENT;TOPICALPrescriptionNoAB209971TORRENT
ACYCLOVIRACYCLOVIR5%OINTMENT;TOPICALPrescriptionNoAB201501XIROMED
ZOVIRAXACYCLOVIR5%OINTMENT;TOPICALPrescriptionYesAB018604BAUSCH
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