Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 077026
Company: HI TECH PHARMA
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
06/07/2005 ORIG-1 Approval

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
11/28/2008 SUPPL-1 Labeling

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 HI TECH PHARMA
ZOVIRAX ACYCLOVIR 200MG/5ML SUSPENSION;ORAL Prescription Yes AB 019909 MYLAN PHARMS INC

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