Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 088383
Company: GRAHAM DM
Company: GRAHAM DM
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| SOMOPHYLLIN-CRT | THEOPHYLLINE | 300MG | CAPSULE, EXTENDED RELEASE;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 |
|---|---|---|---|---|---|---|---|
| 03/14/1997 | 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 |
|---|---|---|---|---|---|
| 03/14/1997 | SUPPL-21 | Labeling |
Label is not available on this site. |
||
| 03/14/1997 | SUPPL-13 | Labeling |
Label is not available on this site. |
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| 03/14/1997 | SUPPL-9 | Labeling |
Label is not available on this site. |
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| 03/14/1997 | SUPPL-6 | Labeling |
Label is not available on this site. |