Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 077561
Company: APOTEX INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ZIPRASIDONE HYDROCHLORIDE ZIPRASIDONE HYDROCHLORIDE EQ 20MG BASE CAPSULE;ORAL Prescription AB No No
ZIPRASIDONE HYDROCHLORIDE ZIPRASIDONE HYDROCHLORIDE EQ 40MG BASE CAPSULE;ORAL Prescription AB No No
ZIPRASIDONE HYDROCHLORIDE ZIPRASIDONE HYDROCHLORIDE EQ 60MG BASE CAPSULE;ORAL Prescription AB No No
ZIPRASIDONE HYDROCHLORIDE ZIPRASIDONE HYDROCHLORIDE EQ 80MG BASE CAPSULE;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
03/02/2012 ORIG-1 Approval Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/077561s000ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
02/18/2016 SUPPL-7 Labeling-Container/Carton Labels, Labeling-Package Insert

Label is not available on this site.

03/18/2015 SUPPL-6 Labeling-Package Insert

Label is not available on this site.

03/18/2015 SUPPL-3 Labeling-Container/Carton Labels, Labeling-Package Insert

Label is not available on this site.

09/18/2013 SUPPL-2 Labeling-Package Insert

Label is not available on this site.

ZIPRASIDONE HYDROCHLORIDE

CAPSULE;ORAL; EQ 20MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
GEODON ZIPRASIDONE HYDROCHLORIDE EQ 20MG BASE CAPSULE;ORAL Prescription Yes AB 020825 PFIZER
ZIPRASIDONE HYDROCHLORIDE ZIPRASIDONE HYDROCHLORIDE EQ 20MG BASE CAPSULE;ORAL Prescription No AB 077561 APOTEX INC
ZIPRASIDONE HYDROCHLORIDE ZIPRASIDONE HYDROCHLORIDE EQ 20MG BASE CAPSULE;ORAL Prescription No AB 204117 AUROBINDO PHARMA LTD
ZIPRASIDONE HYDROCHLORIDE ZIPRASIDONE HYDROCHLORIDE EQ 20MG BASE CAPSULE;ORAL Prescription No AB 208988 CADILA
ZIPRASIDONE HYDROCHLORIDE ZIPRASIDONE HYDROCHLORIDE EQ 20MG BASE CAPSULE;ORAL Prescription No AB 077565 DR REDDYS LABS INC
ZIPRASIDONE HYDROCHLORIDE ZIPRASIDONE HYDROCHLORIDE EQ 20MG BASE CAPSULE;ORAL Prescription No AB 077560 LUPIN PHARMS
ZIPRASIDONE HYDROCHLORIDE ZIPRASIDONE HYDROCHLORIDE EQ 20MG BASE CAPSULE;ORAL Prescription No AB 204375 MACLEODS PHARMS LTD
ZIPRASIDONE HYDROCHLORIDE ZIPRASIDONE HYDROCHLORIDE EQ 20MG BASE CAPSULE;ORAL Prescription No AB 077562 SANDOZ INC
ZIPRASIDONE HYDROCHLORIDE ZIPRASIDONE HYDROCHLORIDE EQ 20MG BASE CAPSULE;ORAL Prescription No AB 090348 WOCKHARDT LTD

CAPSULE;ORAL; EQ 40MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
GEODON ZIPRASIDONE HYDROCHLORIDE EQ 40MG BASE CAPSULE;ORAL Prescription Yes AB 020825 PFIZER
ZIPRASIDONE HYDROCHLORIDE ZIPRASIDONE HYDROCHLORIDE EQ 40MG BASE CAPSULE;ORAL Prescription No AB 077561 APOTEX INC
ZIPRASIDONE HYDROCHLORIDE ZIPRASIDONE HYDROCHLORIDE EQ 40MG BASE CAPSULE;ORAL Prescription No AB 204117 AUROBINDO PHARMA LTD
ZIPRASIDONE HYDROCHLORIDE ZIPRASIDONE HYDROCHLORIDE EQ 40MG BASE CAPSULE;ORAL Prescription No AB 208988 CADILA
ZIPRASIDONE HYDROCHLORIDE ZIPRASIDONE HYDROCHLORIDE EQ 40MG BASE CAPSULE;ORAL Prescription No AB 077565 DR REDDYS LABS INC
ZIPRASIDONE HYDROCHLORIDE ZIPRASIDONE HYDROCHLORIDE EQ 40MG BASE CAPSULE;ORAL Prescription No AB 077560 LUPIN PHARMS
ZIPRASIDONE HYDROCHLORIDE ZIPRASIDONE HYDROCHLORIDE EQ 40MG BASE CAPSULE;ORAL Prescription No AB 204375 MACLEODS PHARMS LTD
ZIPRASIDONE HYDROCHLORIDE ZIPRASIDONE HYDROCHLORIDE EQ 40MG BASE CAPSULE;ORAL Prescription No AB 077562 SANDOZ INC
ZIPRASIDONE HYDROCHLORIDE ZIPRASIDONE HYDROCHLORIDE EQ 40MG BASE CAPSULE;ORAL Prescription No AB 090348 WOCKHARDT LTD

CAPSULE;ORAL; EQ 60MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
GEODON ZIPRASIDONE HYDROCHLORIDE EQ 60MG BASE CAPSULE;ORAL Prescription Yes AB 020825 PFIZER
ZIPRASIDONE HYDROCHLORIDE ZIPRASIDONE HYDROCHLORIDE EQ 60MG BASE CAPSULE;ORAL Prescription No AB 077561 APOTEX INC
ZIPRASIDONE HYDROCHLORIDE ZIPRASIDONE HYDROCHLORIDE EQ 60MG BASE CAPSULE;ORAL Prescription No AB 204117 AUROBINDO PHARMA LTD
ZIPRASIDONE HYDROCHLORIDE ZIPRASIDONE HYDROCHLORIDE EQ 60MG BASE CAPSULE;ORAL Prescription No AB 208988 CADILA
ZIPRASIDONE HYDROCHLORIDE ZIPRASIDONE HYDROCHLORIDE EQ 60MG BASE CAPSULE;ORAL Prescription No AB 077565 DR REDDYS LABS INC
ZIPRASIDONE HYDROCHLORIDE ZIPRASIDONE HYDROCHLORIDE EQ 60MG BASE CAPSULE;ORAL Prescription No AB 077560 LUPIN PHARMS
ZIPRASIDONE HYDROCHLORIDE ZIPRASIDONE HYDROCHLORIDE EQ 60MG BASE CAPSULE;ORAL Prescription No AB 204375 MACLEODS PHARMS LTD
ZIPRASIDONE HYDROCHLORIDE ZIPRASIDONE HYDROCHLORIDE EQ 60MG BASE CAPSULE;ORAL Prescription No AB 077562 SANDOZ INC
ZIPRASIDONE HYDROCHLORIDE ZIPRASIDONE HYDROCHLORIDE EQ 60MG BASE CAPSULE;ORAL Prescription No AB 090348 WOCKHARDT LTD

CAPSULE;ORAL; EQ 80MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
GEODON ZIPRASIDONE HYDROCHLORIDE EQ 80MG BASE CAPSULE;ORAL Prescription Yes AB 020825 PFIZER
ZIPRASIDONE HYDROCHLORIDE ZIPRASIDONE HYDROCHLORIDE EQ 80MG BASE CAPSULE;ORAL Prescription No AB 077561 APOTEX INC
ZIPRASIDONE HYDROCHLORIDE ZIPRASIDONE HYDROCHLORIDE EQ 80MG BASE CAPSULE;ORAL Prescription No AB 204117 AUROBINDO PHARMA LTD
ZIPRASIDONE HYDROCHLORIDE ZIPRASIDONE HYDROCHLORIDE EQ 80MG BASE CAPSULE;ORAL Prescription No AB 208988 CADILA
ZIPRASIDONE HYDROCHLORIDE ZIPRASIDONE HYDROCHLORIDE EQ 80MG BASE CAPSULE;ORAL Prescription No AB 077565 DR REDDYS LABS INC
ZIPRASIDONE HYDROCHLORIDE ZIPRASIDONE HYDROCHLORIDE EQ 80MG BASE CAPSULE;ORAL Prescription No AB 077560 LUPIN PHARMS
ZIPRASIDONE HYDROCHLORIDE ZIPRASIDONE HYDROCHLORIDE EQ 80MG BASE CAPSULE;ORAL Prescription No AB 204375 MACLEODS PHARMS LTD
ZIPRASIDONE HYDROCHLORIDE ZIPRASIDONE HYDROCHLORIDE EQ 80MG BASE CAPSULE;ORAL Prescription No AB 077562 SANDOZ INC
ZIPRASIDONE HYDROCHLORIDE ZIPRASIDONE HYDROCHLORIDE EQ 80MG BASE CAPSULE;ORAL Prescription No AB 090348 WOCKHARDT LTD

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