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Abbreviated New Drug Application (ANDA): 201588
Company: SANDOZ INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
OLANZAPINE OLANZAPINE 10MG/VIAL INJECTABLE;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
10/24/2011 ORIG-1 Approval Not Applicable Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/201588s000ltr.pdf

OLANZAPINE

INJECTABLE;INTRAMUSCULAR; 10MG/VIAL
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
OLANZAPINE OLANZAPINE 10MG/VIAL INJECTABLE;INTRAMUSCULAR Prescription No AP 201741 AM REGENT
OLANZAPINE OLANZAPINE 10MG/VIAL INJECTABLE;INTRAMUSCULAR Prescription No AP 210968 EUGIA PHARMA
OLANZAPINE OLANZAPINE 10MG/VIAL INJECTABLE;INTRAMUSCULAR Prescription No AP 201588 SANDOZ INC
ZYPREXA OLANZAPINE 10MG/VIAL INJECTABLE;INTRAMUSCULAR Prescription Yes AP 021253 LILLY
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