Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 086720
Company: PHARM ASSOC
Company: PHARM ASSOC
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
THEOPHYLLINE | THEOPHYLLINE | 80MG/15ML | ELIXIR;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 |
---|---|---|---|---|---|---|---|
06/25/1980 | 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 |
---|---|---|---|---|---|
03/01/1996 | SUPPL-11 | Labeling |
Label is not available on this site. |
||
03/26/1990 | SUPPL-10 | Labeling |
Label is not available on this site. |
||
07/15/1988 | SUPPL-7 | Labeling |
Label is not available on this site. |
||
07/18/1983 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |