Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 018685
Company: CHATTEM SANOFI
Company: CHATTEM SANOFI
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| GAVISCON | ALUMINUM HYDROXIDE; MAGNESIUM TRISILICATE | 80MG;20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, CHEWABLE;ORAL | Discontinued | None | Yes | No |
| GAVISCON | ALUMINUM HYDROXIDE; MAGNESIUM TRISILICATE | 160MG;40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, CHEWABLE;ORAL | Discontinued | None | Yes | No |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 |
|---|---|---|---|---|---|---|---|
| 12/09/1983 | ORIG-1 | Approval | Type 4 - New Combination | 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 |
|---|---|---|---|---|---|
| 09/13/2002 | SUPPL-15 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 11/08/2000 | SUPPL-14 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 09/22/2000 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
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| 02/28/2000 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
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| 02/07/2000 | SUPPL-11 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 10/04/1999 | SUPPL-10 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 03/17/1998 | SUPPL-9 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 12/01/1997 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
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| 12/01/1997 | SUPPL-7 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 04/29/1999 | SUPPL-6 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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| 01/25/1995 | SUPPL-5 | Labeling |
Label is not available on this site. |
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| 10/01/1991 | SUPPL-4 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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| 02/08/1989 | SUPPL-3 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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| 02/25/1985 | SUPPL-2 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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| 08/01/1984 | SUPPL-1 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |