Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 075382
Company: CARLSBAD
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
04/30/1999 ORIG-1 Approval Letter (PDF)
Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/75382ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/075382_ORIGINAL APPROVAL_PACKAGE.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
09/16/2005 SUPPL-6 Labeling

Label is not available on this site.

04/25/2003 SUPPL-3 Labeling

Label is not available on this site.

09/19/2002 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

11/16/2000 SUPPL-1 Labeling

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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