Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 020089
Company: MYLAN PHARMS INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ZOVIRAX ACYCLOVIR 400MG TABLET;ORAL Prescription AB Yes No
ZOVIRAX ACYCLOVIR 800MG TABLET;ORAL Prescription AB Yes Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
04/30/1991 ORIG-1 Approval Type 3 - New Dosage Form 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
08/08/2008 SUPPL-20 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020089s020, 019909s022, 018828s031ltr.pdf
12/09/2005 SUPPL-19 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/018828s030,020089s019,019909s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/018828s030,020089s019,019909s020ltr.pdf
05/19/2004 SUPPL-18 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/18828slr029,19909slr019,20089slr018_zovirax_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/18828slr029,19909slr019,20089slr018ltr.pdf
11/14/2001 SUPPL-16 Labeling Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20089s15s16lbl.pdf
11/14/2001 SUPPL-15 Labeling Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20089s15s16lbl.pdf
07/12/2000 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

06/10/1999 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

03/15/2000 SUPPL-12 Labeling

Label is not available on this site.

05/29/1997 SUPPL-11 Labeling

Label is not available on this site.

01/08/1997 SUPPL-10 Labeling

Label is not available on this site.

10/29/1996 SUPPL-9 Manufacturing (CMC)-Control

Label is not available on this site.

05/31/1995 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

04/12/1995 SUPPL-7 Labeling

Label is not available on this site.

09/07/1995 SUPPL-5 Manufacturing (CMC)-Formulation

Label is not available on this site.

04/14/1994 SUPPL-4 Labeling

Label is not available on this site.

11/09/1993 SUPPL-3 Manufacturing (CMC)-Control

Label is not available on this site.

02/26/1992 SUPPL-2 Efficacy-New Indication Review

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/020089s002_zovirax_toc.cfm
04/22/1993 SUPPL-1 Labeling

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
12/09/2005 SUPPL-19 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/018828s030,020089s019,019909s020lbl.pdf
05/19/2004 SUPPL-18 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/18828slr029,19909slr019,20089slr018_zovirax_lbl.pdf
11/14/2001 SUPPL-16 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20089s15s16lbl.pdf
11/14/2001 SUPPL-15 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20089s15s16lbl.pdf

ZOVIRAX

TABLET;ORAL; 400MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ACYCLOVIR ACYCLOVIR 400MG TABLET;ORAL Prescription No AB 077309 APOTEX INC
ACYCLOVIR ACYCLOVIR 400MG TABLET;ORAL Prescription No AB 202168 CADILA PHARMS LTD
ACYCLOVIR ACYCLOVIR 400MG TABLET;ORAL Prescription No AB 075382 CARLSBAD
ACYCLOVIR ACYCLOVIR 400MG TABLET;ORAL Prescription No AB 074946 DAVA PHARMS INC
ACYCLOVIR ACYCLOVIR 400MG TABLET;ORAL Prescription No AB 074891 HERITAGE PHARMS INC
ACYCLOVIR ACYCLOVIR 400MG TABLET;ORAL Prescription No AB 203834 HETERO LABS LTD V
ACYCLOVIR ACYCLOVIR 400MG TABLET;ORAL Prescription No AB 075211 MYLAN PHARMS INC
ACYCLOVIR ACYCLOVIR 400MG TABLET;ORAL Prescription No AB 074556 TEVA
ACYCLOVIR ACYCLOVIR 400MG TABLET;ORAL Prescription No AB 204314 ZYDUS PHARMS USA INC
ZOVIRAX ACYCLOVIR 400MG TABLET;ORAL Prescription Yes AB 020089 MYLAN PHARMS INC

TABLET;ORAL; 800MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ACYCLOVIR ACYCLOVIR 800MG TABLET;ORAL Prescription No AB 077309 APOTEX INC
ACYCLOVIR ACYCLOVIR 800MG TABLET;ORAL Prescription No AB 202168 CADILA PHARMS LTD
ACYCLOVIR ACYCLOVIR 800MG TABLET;ORAL Prescription No AB 075382 CARLSBAD
ACYCLOVIR ACYCLOVIR 800MG TABLET;ORAL Prescription No AB 074946 DAVA PHARMS INC
ACYCLOVIR ACYCLOVIR 800MG TABLET;ORAL Prescription No AB 074891 HERITAGE PHARMS INC
ACYCLOVIR ACYCLOVIR 800MG TABLET;ORAL Prescription No AB 203834 HETERO LABS LTD V
ACYCLOVIR ACYCLOVIR 800MG TABLET;ORAL Prescription No AB 075211 MYLAN PHARMS INC
ACYCLOVIR ACYCLOVIR 800MG TABLET;ORAL Prescription No AB 074556 TEVA
ACYCLOVIR ACYCLOVIR 800MG TABLET;ORAL Prescription No AB 204314 ZYDUS PHARMS USA INC
ZOVIRAX ACYCLOVIR 800MG TABLET;ORAL Prescription Yes AB 020089 MYLAN PHARMS INC

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