Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 014740
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.

03/01/1989 SUPPL-53 Labeling

Label is not available on this site.

03/01/1989 SUPPL-52 Labeling

Label is not available on this site.

03/01/1989 SUPPL-51 Labeling

Label is not available on this site.

03/27/1996 SUPPL-48 Labeling

Label is not available on this site.

06/24/1983 SUPPL-47 Labeling

Label is not available on this site.

06/24/1983 SUPPL-46 Labeling

Label is not available on this site.

03/27/1996 SUPPL-42 Labeling

Label is not available on this site.

03/06/1980 SUPPL-41 Efficacy

Label is not available on this site.

03/27/1996 SUPPL-40 Efficacy

Label is not available on this site.

03/27/1996 SUPPL-38 Efficacy

Label is not available on this site.

03/27/1996 SUPPL-37 Efficacy

Label is not available on this site.

10/06/1978 SUPPL-36 Efficacy

Label is not available on this site.

03/27/1996 SUPPL-34 Efficacy

Label is not available on this site.

03/27/1996 SUPPL-31 Labeling

Label is not available on this site.

03/27/1996 SUPPL-30 Labeling

Label is not available on this site.

03/27/1996 SUPPL-19 Labeling

Label is not available on this site.

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