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ACYCLOVIR از شرکت HERITAGE PHARMS INC

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ACYCLOVIR از شرکت HERITAGE PHARMS INC

Abbreviated New Drug Application (ANDA): 074891

Company: HERITAGE 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
10/31/1997 ORIG-1 Approval

Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/97/074891_ORIGINAL APPROVAL_PACKAGE.pdf

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 209366 SQUARE PHARMS LTD
ACYCLOVIR ACYCLOVIR 400MG TABLET;ORAL Prescription No AB 074556 TEVA
ACYCLOVIR ACYCLOVIR 400MG TABLET;ORAL Prescription No AB 210401 YILING
ACYCLOVIR ACYCLOVIR 400MG TABLET;ORAL Prescription No AB 204314 ZYDUS PHARMS

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 209366 SQUARE PHARMS LTD
ACYCLOVIR ACYCLOVIR 800MG TABLET;ORAL Prescription No AB 074556 TEVA
ACYCLOVIR ACYCLOVIR 800MG TABLET;ORAL Prescription No AB 210401 YILING
ACYCLOVIR ACYCLOVIR 800MG TABLET;ORAL Prescription No AB 204314 ZYDUS PHARMS
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