Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 085169
Company: HALSEY
Company: HALSEY
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 |
---|---|---|---|---|---|---|---|
02/08/1979 | 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 |
---|---|---|---|---|---|
12/12/1996 | SUPPL-23 | Labeling |
Label is not available on this site. |
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03/22/1991 | SUPPL-22 | Labeling |
Label is not available on this site. |
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01/22/1991 | SUPPL-21 | Labeling |
Label is not available on this site. |
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12/14/1988 | SUPPL-20 | Labeling |
Label is not available on this site. |