Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 075211
Company: MYLAN PHARMS INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ACYCLOVIR ACYCLOVIR 400MG TABLET;ORAL Prescription AB No No
ACYCLOVIR ACYCLOVIR 800MG TABLET;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
09/28/1998 ORIG-1 Approval Letter (PDF)
Review

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/75211ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/98/075211_acyclovir_toc.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
12/07/2009 SUPPL-9 Labeling-Container/Carton Labels

Label is not available on this site.

10/21/2004 SUPPL-6 Labeling

Label is not available on this site.

07/31/2002 SUPPL-4 Labeling

Label is not available on this site.

03/13/2002 SUPPL-3 Labeling

Label is not available on this site.

04/18/2001 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

07/23/1999 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

ACYCLOVIR

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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