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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 211908
Company: GLAND PHARMA LTD
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ZIPRASIDONE MESYLATE ZIPRASIDONE MESYLATE EQ 20MG BASE/VIAL POWDER;INTRAMUSCULAR 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
12/26/2019 ORIG-1 Approval STANDARD Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/211908Orig1s000ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
02/02/2021 SUPPL-2 Labeling-Package Insert, Labeling-Container/Carton Labels

Label is not available on this site.

02/02/2021 SUPPL-1 Labeling-Package Insert

Label is not available on this site.

ZIPRASIDONE MESYLATE

POWDER;INTRAMUSCULAR; EQ 20MG BASE/VIAL
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
GEODON ZIPRASIDONE MESYLATE EQ 20MG BASE/VIAL POWDER;INTRAMUSCULAR Prescription Yes AP 020919 VIATRIS
ZIPRASIDONE MESYLATE ZIPRASIDONE MESYLATE EQ 20MG BASE/VIAL POWDER;INTRAMUSCULAR Prescription No AP 211908 GLAND PHARMA LTD
ZIPRASIDONE MESYLATE ZIPRASIDONE MESYLATE EQ 20MG BASE/VIAL POWDER;INTRAMUSCULAR Prescription No AP 216091 MSN
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