Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 009660
Company: ROCHE
Company: ROCHE
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| NOLUDAR | METHYPRYLON | 50MG | TABLET;ORAL | Discontinued | None | No | No |
| NOLUDAR | METHYPRYLON | 200MG | TABLET;ORAL | Discontinued | None | No | No |
| NOLUDAR | METHYPRYLON | 50MG/5ML | ELIXIR;ORAL | Discontinued | None | No | No |
| NOLUDAR | METHYPRYLON | 300MG | 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 |
|---|---|---|---|---|---|---|---|
| 01/18/1955 | 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 |
|---|---|---|---|---|---|
| 08/27/1986 | SUPPL-16 | Labeling |
Label is not available on this site. |
||
| 02/26/1982 | SUPPL-14 | Labeling |
Label is not available on this site. |
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| 12/15/1980 | SUPPL-13 | Labeling |
Label is not available on this site. |
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| 03/21/1979 | SUPPL-12 | Labeling |
Label is not available on this site. |
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| 10/27/1978 | SUPPL-10 | Labeling |
Label is not available on this site. |
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| 04/26/1996 | SUPPL-9 | Labeling |
Label is not available on this site. |
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| 06/23/1977 | SUPPL-8 | Labeling |
Label is not available on this site. |
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| 06/23/1977 | SUPPL-7 | Labeling |
Label is not available on this site. |