Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

New Drug Application (NDA): 011878
Company: NOVARTIS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
SERPASIL-ESIDRIX #1 HYDROCHLOROTHIAZIDE; RESERPINE 25MG;0.1MG TABLET;ORAL Discontinued None No No
SERPASIL-ESIDRIX #2 HYDROCHLOROTHIAZIDE; RESERPINE 50MG;0.1MG 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
05/05/1959 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
05/22/1987 SUPPL-30 Labeling

Label is not available on this site.

10/02/1985 SUPPL-29 Labeling

Label is not available on this site.

07/14/1983 SUPPL-27 Labeling

Label is not available on this site.

04/18/1985 SUPPL-26 Labeling

Label is not available on this site.

05/16/1977 SUPPL-20 Labeling

Label is not available on this site.

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English