Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 019518
Company: CHESEBROUGH PONDS
Company: CHESEBROUGH PONDS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| EXTRA-STRENGTH AIM | SODIUM MONOFLUOROPHOSPHATE | 1.2% | PASTE;DENTAL | Discontinued | None | No | No |
| EXTRA-STRENGTH AIM | SODIUM MONOFLUOROPHOSPHATE | 1.2% | GEL;DENTAL | 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 |
|---|---|---|---|---|---|---|---|
| 08/06/1986 | 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 |
|---|---|---|---|---|---|
| 01/24/1989 | SUPPL-15 | Labeling |
Label is not available on this site. |
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| 12/09/1988 | SUPPL-10 | Labeling |
Label is not available on this site. |
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| 06/21/1988 | SUPPL-8 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 03/10/1992 | SUPPL-7 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 03/10/1992 | SUPPL-6 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 08/03/1987 | SUPPL-4 | Labeling |
Label is not available on this site. |
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| 08/03/1987 | SUPPL-3 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 06/03/1987 | SUPPL-2 | Labeling |
Label is not available on this site. |
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| 06/03/1987 | SUPPL-1 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |