Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 087045
Company: FISONS
Company: FISONS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
SOMOPHYLLIN-DF | AMINOPHYLLINE | 105MG/5ML | SOLUTION;ORAL | 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 |
---|---|---|---|---|---|---|---|
09/30/1980 | ORIG-1 | Approval |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
10/31/1990 | SUPPL-15 | Labeling |
Label is not available on this site. |
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07/20/1989 | SUPPL-13 | Labeling |
Label is not available on this site. |