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ACYCLOVIR از شرکت ALEMBIC PHARMS LTD

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ACYCLOVIR از شرکت ALEMBIC PHARMS LTD

Abbreviated New Drug Application (ANDA): 209000

Company: ALEMBIC PHARMS LTD

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
04/06/2018 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
07/12/2019 SUPPL-1 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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