Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 019669
Company: BRISTOL MYERS
Company: BRISTOL MYERS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| QUESTRAN LIGHT | CHOLESTYRAMINE | EQ 4GM RESIN/PACKET **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | POWDER;ORAL | Discontinued | None | Yes | No |
| QUESTRAN LIGHT | CHOLESTYRAMINE | EQ 4GM RESIN/SCOOPFUL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | POWDER;ORAL | Discontinued | None | Yes | No |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 |
|---|---|---|---|---|---|---|---|
| 12/05/1988 | ORIG-1 | Approval | Type 3 - New Dosage Form | STANDARD |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 03/20/2000 | SUPPL-24 | Labeling |
Label is not available on this site. |
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| 10/29/1997 | SUPPL-23 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
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| 08/22/1997 | SUPPL-22 | Labeling |
Label is not available on this site. |
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| 12/12/1994 | SUPPL-19 | Labeling |
Label is not available on this site. |
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| 09/22/1995 | SUPPL-18 | Labeling |
Label is not available on this site. |
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| 09/22/1995 | SUPPL-17 | Labeling |
Label is not available on this site. |
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| 01/07/1993 | SUPPL-16 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 08/11/1992 | SUPPL-15 | Labeling |
Label is not available on this site. |
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| 09/22/1992 | SUPPL-14 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 09/10/1991 | SUPPL-12 | Labeling |
Label is not available on this site. |
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| 03/12/1991 | SUPPL-9 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 02/02/1990 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
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| 11/27/1989 | SUPPL-7 | Labeling |
Label is not available on this site. |
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| 02/21/1989 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
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| 02/21/1989 | SUPPL-2 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 02/21/1989 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |