Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 014740
Company: ROCHE
Company: ROCHE
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| MENRIUM 10-4 | CHLORDIAZEPOXIDE; ESTROGENS, ESTERIFIED | 10MG;0.4MG | TABLET;ORAL | Discontinued | None | No | No |
| MENRIUM 5-2 | CHLORDIAZEPOXIDE; ESTROGENS, ESTERIFIED | 5MG;0.2MG | TABLET;ORAL | Discontinued | None | No | No |
| MENRIUM 5-4 | CHLORDIAZEPOXIDE; ESTROGENS, ESTERIFIED | 5MG;0.4MG | TABLET;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 |
|---|---|---|---|---|---|---|---|
| 07/28/1966 | 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 |
|---|---|---|---|---|---|
| 03/27/1996 | SUPPL-54 | Labeling |
Label is not available on this site. |
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| 03/01/1989 | SUPPL-53 | Labeling |
Label is not available on this site. |
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| 03/01/1989 | SUPPL-52 | Labeling |
Label is not available on this site. |
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| 03/01/1989 | SUPPL-51 | Labeling |
Label is not available on this site. |
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| 03/27/1996 | SUPPL-48 | Labeling |
Label is not available on this site. |
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| 06/24/1983 | SUPPL-47 | Labeling |
Label is not available on this site. |
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| 06/24/1983 | SUPPL-46 | Labeling |
Label is not available on this site. |
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| 03/27/1996 | SUPPL-42 | Labeling |
Label is not available on this site. |
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| 03/06/1980 | SUPPL-41 | Efficacy |
Label is not available on this site. |
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| 03/27/1996 | SUPPL-40 | Efficacy |
Label is not available on this site. |
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| 03/27/1996 | SUPPL-38 | Efficacy |
Label is not available on this site. |
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| 03/27/1996 | SUPPL-37 | Efficacy |
Label is not available on this site. |
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| 10/06/1978 | SUPPL-36 | Efficacy |
Label is not available on this site. |
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| 03/27/1996 | SUPPL-34 | Efficacy |
Label is not available on this site. |
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| 03/27/1996 | SUPPL-31 | Labeling |
Label is not available on this site. |
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| 03/27/1996 | SUPPL-30 | Labeling |
Label is not available on this site. |
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| 03/27/1996 | SUPPL-19 | Labeling |
Label is not available on this site. |