Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 018144
Company: PARKE DAVIS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CENTRAX PRAZEPAM 5MG CAPSULE;ORAL Discontinued None No No
CENTRAX PRAZEPAM 10MG CAPSULE;ORAL Discontinued None No No
CENTRAX PRAZEPAM 20MG 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
11/30/1979 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
04/26/1996 SUPPL-16 Labeling

Label is not available on this site.

04/26/1996 SUPPL-15 Labeling

Label is not available on this site.

04/26/1996 SUPPL-13 Labeling

Label is not available on this site.

04/26/1996 SUPPL-11 Labeling

Label is not available on this site.

04/26/1996 SUPPL-9 Labeling

Label is not available on this site.

05/01/1984 SUPPL-8 Labeling

Label is not available on this site.

05/27/1980 SUPPL-1 Labeling

Label is not available on this site.

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