Drugs@FDA: FDA-Approved Drugs
Company: ALPHA THERA
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 |
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. |