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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 210968
Company: EUGIA PHARMA
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
10/22/2020 ORIG-1 Approval STANDARD

Label is not available on this site.

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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