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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 077560
Company: LUPIN PHARMS

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ZIPRASIDONE HYDROCHLORIDE ZIPRASIDONE HYDROCHLORIDE EQ 20MG BASE CAPSULE;ORAL Discontinued None No No
ZIPRASIDONE HYDROCHLORIDE ZIPRASIDONE HYDROCHLORIDE EQ 40MG BASE CAPSULE;ORAL Discontinued None No No
ZIPRASIDONE HYDROCHLORIDE ZIPRASIDONE HYDROCHLORIDE EQ 60MG BASE CAPSULE;ORAL Discontinued None No No
ZIPRASIDONE HYDROCHLORIDE ZIPRASIDONE HYDROCHLORIDE EQ 80MG BASE CAPSULE;ORAL Discontinued None 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
03/02/2012 ORIG-1 Approval Letter (PDF)

Label is not available on this site.

 https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/077560_TA_ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
09/30/2025 SUPPL-25 Labeling-Medication Guide, Labeling-Package Insert, Labeling-Container/Carton Labels, Labeling-Patient Package Insert

Label is not available on this site.
03/30/2023 SUPPL-22 Labeling-Package Insert, Labeling-Patient Package Insert

Label is not available on this site.
03/30/2023 SUPPL-21 Labeling-Package Insert, Labeling-Patient Package Insert

Label is not available on this site.
03/30/2023 SUPPL-19 Labeling-Package Insert

Label is not available on this site.
03/26/2021 SUPPL-18 Labeling-Patient Package Insert, Labeling-Package Insert, Labeling-Container/Carton Labels

Label is not available on this site.
03/26/2021 SUPPL-17 Labeling-Patient Package Insert, Labeling-Package Insert

Label is not available on this site.
03/26/2021 SUPPL-13 Labeling-Package Insert

Label is not available on this site.
02/23/2016 SUPPL-11 Labeling-Package Insert

Label is not available on this site.
03/18/2015 SUPPL-8 Labeling-Package Insert

Label is not available on this site.
04/24/2014 SUPPL-5 Labeling-Package Insert

Label is not available on this site.
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