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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 213951
Company: VISTAPHARM
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ACYCLOVIR ACYCLOVIR 200MG/5ML SUSPENSION;ORAL 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
01/11/2021 ORIG-1 Approval STANDARD

Label is not available on this site.

ACYCLOVIR

SUSPENSION;ORAL; 200MG/5ML
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ACYCLOVIR ACYCLOVIR 200MG/5ML SUSPENSION;ORAL Prescription No AB 074738 ACTAVIS MID ATLANTIC
ACYCLOVIR ACYCLOVIR 200MG/5ML SUSPENSION;ORAL Prescription No AB 077026 AKORN
ACYCLOVIR ACYCLOVIR 200MG/5ML SUSPENSION;ORAL Prescription No AB 216331 AUROBINDO PHARMA LTD
ACYCLOVIR ACYCLOVIR 200MG/5ML SUSPENSION;ORAL Prescription No AB 212718 HERITAGE PHARMS INC
ACYCLOVIR ACYCLOVIR 200MG/5ML SUSPENSION;ORAL Prescription No AB 215669 HETERO LABS LTD III
ACYCLOVIR ACYCLOVIR 200MG/5ML SUSPENSION;ORAL Prescription No AB 212252 NOVITIUM PHARMA
ACYCLOVIR ACYCLOVIR 200MG/5ML SUSPENSION;ORAL Prescription No AB 213951 VISTAPHARM
ZOVIRAX ACYCLOVIR 200MG/5ML SUSPENSION;ORAL Prescription Yes AB 019909 MYLAN
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