Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 020162
Company: FERRING
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ACTHREL CORTICORELIN OVINE TRIFLUTATE EQ 0.1MG BASE/VIAL INJECTABLE;INJECTION Prescription None Yes Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
05/23/1996 ORIG-1 Approval Type 1 - New Molecular Entity PRIORITY; Orphan

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
09/01/2015 SUPPL-10 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020162s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020162Orig1s010ltr.pdf
01/31/2014 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

07/16/2002 SUPPL-3 Manufacturing (CMC)-Control

Label is not available on this site.

04/24/1997 SUPPL-2 Manufacturing (CMC)-Formulation

Label is not available on this site.

04/04/1997 SUPPL-1 Manufacturing (CMC)-Formulation

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
09/01/2015 SUPPL-10 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020162s010lbl.pdf

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