Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 074738
Company: ACTAVIS MID ATLANTIC
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
04/28/1997 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
06/10/2009 SUPPL-28 Labeling

Label is not available on this site.

01/24/2005 SUPPL-12 Labeling

Label is not available on this site.

09/18/2002 SUPPL-7 Labeling

Label is not available on this site.

02/22/2002 SUPPL-6 Manufacturing (CMC)-Control

Label is not available on this site.

06/13/2001 SUPPL-5 Labeling

Label is not available on this site.

11/16/2000 SUPPL-4 Labeling

Label is not available on this site.

01/16/2001 SUPPL-3 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

07/06/1998 SUPPL-2 Labeling

Label is not available on this site.

03/26/1998 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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