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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 210118
Company: TEVA PHARMS USA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ICATIBANT ACETATE ICATIBANT ACETATE EQ 30MG BASE/3ML (EQ 10MG BASE/ML) INJECTABLE;SUBCUTANEOUS 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
07/15/2019 ORIG-1 Approval STANDARD Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/210118Orig1s000ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
09/25/2020 SUPPL-2 Labeling-Package Insert, Labeling-Patient Package Insert

Label is not available on this site.

ICATIBANT ACETATE

INJECTABLE;SUBCUTANEOUS; EQ 30MG BASE/3ML (EQ 10MG BASE/ML)
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
FIRAZYR ICATIBANT ACETATE EQ 30MG BASE/3ML (EQ 10MG BASE/ML) INJECTABLE;SUBCUTANEOUS Prescription Yes AP 022150 TAKEDA PHARMS USA
ICATIBANT ACETATE ICATIBANT ACETATE EQ 30MG BASE/3ML (EQ 10MG BASE/ML) INJECTABLE;SUBCUTANEOUS Prescription No AP 212446 CIPLA
ICATIBANT ACETATE ICATIBANT ACETATE EQ 30MG BASE/3ML (EQ 10MG BASE/ML) INJECTABLE;SUBCUTANEOUS Prescription No AP 208317 FRESENIUS KABI USA
ICATIBANT ACETATE ICATIBANT ACETATE EQ 30MG BASE/3ML (EQ 10MG BASE/ML) INJECTABLE;SUBCUTANEOUS Prescription No AP 211021 JIANGSU HANSOH PHARM
ICATIBANT ACETATE ICATIBANT ACETATE EQ 30MG BASE/3ML (EQ 10MG BASE/ML) INJECTABLE;SUBCUTANEOUS Prescription No AP 212081 NANG KUANG PHARM CO
ICATIBANT ACETATE ICATIBANT ACETATE EQ 30MG BASE/3ML (EQ 10MG BASE/ML) INJECTABLE;SUBCUTANEOUS Prescription No AP 211501 SLAYBACK PHARMA LLC
ICATIBANT ACETATE ICATIBANT ACETATE EQ 30MG BASE/3ML (EQ 10MG BASE/ML) INJECTABLE;SUBCUTANEOUS Prescription No AP 210118 TEVA PHARMS USA
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