Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

Abbreviated New Drug Application (ANDA): 071388
Company: ROXANE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PROPRANOLOL HYDROCHLORIDE INTENSOL PROPRANOLOL HYDROCHLORIDE 80MG/ML CONCENTRATE;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
05/15/1987 ORIG-1 Approval

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
08/01/2001 SUPPL-15 Labeling

Label is not available on this site.

02/20/2001 SUPPL-14 Manufacturing (CMC)-Control

Label is not available on this site.

02/20/2001 SUPPL-13 Manufacturing (CMC)-Packaging

Label is not available on this site.

08/28/1996 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

01/05/1994 SUPPL-9 Labeling

Label is not available on this site.

05/16/1991 SUPPL-8 Labeling

Label is not available on this site.

10/09/1990 SUPPL-7 Labeling

Label is not available on this site.

03/09/1990 SUPPL-6 Labeling

Label is not available on this site.

01/16/1990 SUPPL-5 Labeling

Label is not available on this site.

02/28/1990 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

12/21/1988 SUPPL-2 Manufacturing (CMC)

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