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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 206535
Company: ZYDUS PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ACYCLOVIR SODIUM ACYCLOVIR SODIUM EQ 50MG BASE/ML INJECTABLE;INJECTION Prescription AP 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
08/31/2018 ORIG-1 Approval 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
08/23/2021 SUPPL-4 Labeling-Package Insert, Labeling-Container/Carton Labels

Label is not available on this site.

ACYCLOVIR SODIUM

INJECTABLE;INJECTION; EQ 50MG BASE/ML
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ACYCLOVIR SODIUM ACYCLOVIR SODIUM EQ 50MG BASE/ML INJECTABLE;INJECTION Prescription No AP 207919 AM INJECTABLES
ACYCLOVIR SODIUM ACYCLOVIR SODIUM EQ 50MG BASE/ML INJECTABLE;INJECTION Prescription No AP 203701 EUGIA PHARMA
ACYCLOVIR SODIUM ACYCLOVIR SODIUM EQ 50MG BASE/ML INJECTABLE;INJECTION Prescription No AP 074930 FRESENIUS KABI USA
ACYCLOVIR SODIUM ACYCLOVIR SODIUM EQ 50MG BASE/ML INJECTABLE;INJECTION Prescription No AP 206535 ZYDUS PHARMS
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