Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 018828
Company: MYLAN PHARMS INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ZOVIRAX ACYCLOVIR 200MG CAPSULE;ORAL Prescription AB Yes 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
01/25/1985 ORIG-1 Approval Type 3 - New Dosage Form PRIORITY

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-31 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/018828s031lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020089s020, 019909s022, 018828s031ltr.pdf
12/09/2005 SUPPL-30 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-29 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-27 Labeling Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/18828s26s27lbl.pdf
11/14/2001 SUPPL-26 Labeling Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/18828s26s27lbl.pdf
07/12/2000 SUPPL-25 Manufacturing (CMC)

Label is not available on this site.

03/15/2000 SUPPL-24 Labeling

Label is not available on this site.

02/18/1999 SUPPL-23 Manufacturing (CMC)-Packaging

Label is not available on this site.

03/15/2000 SUPPL-22 Labeling

Label is not available on this site.

11/04/1997 SUPPL-21 Manufacturing (CMC)

Label is not available on this site.

05/29/1997 SUPPL-20 Labeling

Label is not available on this site.

01/08/1997 SUPPL-19 Labeling

Label is not available on this site.

10/29/1996 SUPPL-18 Manufacturing (CMC)-Control

Label is not available on this site.

04/12/1995 SUPPL-17 Labeling

Label is not available on this site.

04/14/1994 SUPPL-14 Labeling

Label is not available on this site.

11/09/1993 SUPPL-13 Manufacturing (CMC)-Control

Label is not available on this site.

04/22/1993 SUPPL-12 Labeling

Label is not available on this site.

02/26/1992 SUPPL-10 Efficacy-New Indication Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/18828S010_Zovirax.pdf
04/30/1991 SUPPL-9 Labeling

Label is not available on this site.

10/24/1988 SUPPL-8 Labeling

Label is not available on this site.

04/20/1990 SUPPL-7 Efficacy-New Indication

Label is not available on this site.

10/24/1988 SUPPL-6 Manufacturing (CMC)-Control

Label is not available on this site.

04/22/1993 SUPPL-5 Labeling

Label is not available on this site.

10/29/1987 SUPPL-3 Labeling

Label is not available on this site.

12/02/1986 SUPPL-2 Labeling

Label is not available on this site.

12/22/1989 SUPPL-1 Efficacy-New Indication

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
08/08/2008 SUPPL-31 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/018828s031lbl.pdf
12/09/2005 SUPPL-30 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/018828s030,020089s019,019909s020lbl.pdf
05/19/2004 SUPPL-29 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/18828slr029,19909slr019,20089slr018_zovirax_lbl.pdf
11/14/2001 SUPPL-27 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/18828s26s27lbl.pdf
11/14/2001 SUPPL-26 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/18828s26s27lbl.pdf

ZOVIRAX

CAPSULE;ORAL; 200MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ACYCLOVIR ACYCLOVIR 200MG CAPSULE;ORAL Prescription No AB 075677 APOTEX INC
ACYCLOVIR ACYCLOVIR 200MG CAPSULE;ORAL Prescription No AB 075090 BOSCOGEN
ACYCLOVIR ACYCLOVIR 200MG CAPSULE;ORAL Prescription No AB 201445 CADILA PHARMS LTD
ACYCLOVIR ACYCLOVIR 200MG CAPSULE;ORAL Prescription No AB 206261 CARLSBAD TECHNOLOGY
ACYCLOVIR ACYCLOVIR 200MG CAPSULE;ORAL Prescription No AB 074833 DAVA PHARMS INC
ACYCLOVIR ACYCLOVIR 200MG CAPSULE;ORAL Prescription No AB 074889 HERITAGE PHARMS INC
ACYCLOVIR ACYCLOVIR 200MG CAPSULE;ORAL Prescription No AB 074578 TEVA
ACYCLOVIR ACYCLOVIR 200MG CAPSULE;ORAL Prescription No AB 204313 ZYDUS PHARMS USA INC
ZOVIRAX ACYCLOVIR 200MG CAPSULE;ORAL Prescription Yes AB 018828 MYLAN PHARMS INC

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