Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 088743
Company: GRAHAM DM
Company: GRAHAM DM
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | ACETAMINOPHEN; BUTALBITAL; CAFFEINE | 325MG;50MG;40MG | CAPSULE;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 |
|---|---|---|---|---|---|---|---|
| 07/18/1985 | 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 |
|---|---|---|---|---|---|
| 10/24/1996 | SUPPL-17 | Labeling |
Label is not available on this site. |
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| 10/24/1996 | SUPPL-16 | Labeling |
Label is not available on this site. |
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| 02/16/1996 | SUPPL-13 | Labeling |
Label is not available on this site. |
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| 03/20/1992 | SUPPL-12 | Labeling |
Label is not available on this site. |
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| 02/07/1989 | SUPPL-10 | Labeling |
Label is not available on this site. |
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| 03/31/1989 | SUPPL-2 | Labeling |
Label is not available on this site. |