Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 018312
Company: ORGANON USA INC
Company: ORGANON USA INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CALDEROL | CALCIFEDIOL | 0.02MG | CAPSULE;ORAL | Discontinued | None | No | No |
| CALDEROL | CALCIFEDIOL | 0.05MG | 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 |
|---|---|---|---|---|---|---|---|
| 08/05/1980 | ORIG-1 | Approval | Type 1 - New Molecular Entity | 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 |
|---|---|---|---|---|---|
| 06/15/2000 | SUPPL-12 | Labeling |
Label is not available on this site. |
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| 12/09/1997 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
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| 02/18/1994 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
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| 11/30/1988 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
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| 06/16/1986 | SUPPL-8 | Labeling |
Label is not available on this site. |
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| 06/16/1986 | SUPPL-7 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 06/12/1984 | SUPPL-4 | Labeling |
Label is not available on this site. |