Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 017836
Company: ISO TEX
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
JEANATOPE ALBUMIN IODINATED I-125 SERUM 500uCi/0.5ML INJECTABLE;INJECTION Prescription None Yes No
JEANATOPE ALBUMIN IODINATED I-125 SERUM 1,000uCi/ML INJECTABLE;INJECTION Prescription None Yes Yes
JEANATOPE ALBUMIN IODINATED I-125 SERUM 100uCi/10ML (10uCi/ML) INJECTABLE;INJECTION Prescription None Yes 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
02/23/1976 ORIG-1 Approval Type 1 - New Molecular Entity PRIORITY

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
06/08/2004 SUPPL-8 Manufacturing (CMC)-Control Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/17836scs008ltr.pdf
05/21/1996 SUPPL-7 Manufacturing (CMC)-Control

Label is not available on this site.

02/03/1977 SUPPL-4 Labeling

Label is not available on this site.

02/03/1977 SUPPL-3 Labeling

Label is not available on this site.

02/03/1977 SUPPL-2 Labeling

Label is not available on this site.

10/08/1976 SUPPL-1 Labeling

Label is not available on this site.

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