Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 018786
Company: ALPHA THERA

Products on NDA 018786

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
SOYACAL 20%	SOYBEAN OIL	20%	INJECTABLE;INJECTION	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 018786

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-17	Manufacturing (CMC)		Label is not available on this site.
05/30/1990	SUPPL-16	Manufacturing (CMC)		Label is not available on this site.
01/17/1989	SUPPL-15	Manufacturing (CMC)		Label is not available on this site.
05/20/1988	SUPPL-14	Labeling		Label is not available on this site.
05/20/1988	SUPPL-13	Manufacturing (CMC)		Label is not available on this site.
01/27/1989	SUPPL-12	Manufacturing (CMC)		Label is not available on this site.
05/20/1988	SUPPL-11	Labeling		Label is not available on this site.
05/20/1988	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.
06/25/1985	SUPPL-5	Labeling		Label is not available on this site.
07/25/1984	SUPPL-4	Manufacturing (CMC)		Label is not available on this site.
08/02/1984	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.