Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 071793
Company: GUARDIAN DRUG
Company: GUARDIAN DRUG
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| FOAMCOAT | ALUMINUM HYDROXIDE; MAGNESIUM TRISILICATE | 80MG;20MG | TABLET, CHEWABLE;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 |
|---|---|---|---|---|---|---|---|
| 09/04/1987 | 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 |
|---|---|---|---|---|---|
| 06/05/2001 | SUPPL-9 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
| 06/05/2001 | SUPPL-8 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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| 06/05/2001 | SUPPL-7 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 06/05/2001 | SUPPL-6 | Manufacturing (CMC)-Manufacturing Process |
Label is not available on this site. |
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| 06/05/2001 | SUPPL-5 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
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| 11/25/1992 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
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| 11/25/1992 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |