Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 018465
Company: ALPHA THERA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
SOYACAL 10% SOYBEAN OIL 10% 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
06/29/1983 ORIG-1 Approval Type 5 - New Formulation or New Manufacturer STANDARD

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
11/07/1991 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

05/30/1990 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

01/17/1989 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

05/20/1988 SUPPL-12 Labeling

Label is not available on this site.

05/20/1988 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

01/27/1989 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

09/08/1986 SUPPL-9 Labeling

Label is not available on this site.

09/08/1986 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

12/11/1985 SUPPL-7 Labeling

Label is not available on this site.

12/11/1985 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

05/20/1988 SUPPL-5 Labeling

Label is not available on this site.

05/20/1988 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

06/25/1985 SUPPL-3 Labeling

Label is not available on this site.

08/02/1984 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

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