Drugs@FDA: FDA-Approved Drugs

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Biologic License Application (BLA): 017837
Company: ISO TEX
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
MEGATOPE ALBUMIN IODINATED I-131 SERUM 0.5mCi/VIAL INJECTABLE;INJECTION Prescription None No No
MEGATOPE ALBUMIN IODINATED I-131 SERUM 1mCi/VIAL INJECTABLE;INJECTION Prescription None No No
MEGATOPE ALBUMIN IODINATED I-131 SERUM 2mCi/VIAL INJECTABLE;INJECTION Discontinued None No No
MEGATOPE ALBUMIN IODINATED I-131 SERUM 5uCi/AMP INJECTABLE;INJECTION Discontinued None No No
MEGATOPE ALBUMIN IODINATED I-131 SERUM 20uCi/AMP INJECTABLE;INJECTION Discontinued None 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
02/23/1976 ORIG-1 Approval N/A

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
05/21/1996 SUPPL-15 Supplement

Label is not available on this site.

09/30/1985 SUPPL-13 Supplement

Label is not available on this site.

01/22/1985 SUPPL-12 Supplement

Label is not available on this site.

10/04/1983 SUPPL-11 Supplement

Label is not available on this site.

10/25/1983 SUPPL-10 Supplement

Label is not available on this site.

08/17/1981 SUPPL-9 Supplement

Label is not available on this site.

11/16/1978 SUPPL-6 Supplement

Label is not available on this site.

10/14/1977 SUPPL-5 Supplement

Label is not available on this site.

10/14/1977 SUPPL-4 Supplement

Label is not available on this site.

10/14/1977 SUPPL-3 Supplement

Label is not available on this site.

10/14/1977 SUPPL-2 Supplement

Label is not available on this site.

10/14/1977 SUPPL-1 Supplement

Label is not available on this site.

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