Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

New Drug Application (NDA): 008732
Company: SHIRE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PRO-BANTHINE PROPANTHELINE BROMIDE 15MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET;ORAL Discontinued None Yes No
PRO-BANTHINE PROPANTHELINE BROMIDE 7.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET;ORAL Discontinued None Yes No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
04/02/1953 ORIG-1 Approval Type 1 - New Molecular Entity 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
02/17/1989 SUPPL-34 Labeling

Label is not available on this site.

02/11/1988 SUPPL-33 Labeling

Label is not available on this site.

02/11/1988 SUPPL-32 Labeling

Label is not available on this site.

06/09/1983 SUPPL-31 Manufacturing (CMC)

Label is not available on this site.

02/11/1988 SUPPL-29 Labeling

Label is not available on this site.

04/06/1981 SUPPL-28 Manufacturing (CMC)-Packaging

Label is not available on this site.

03/18/1981 SUPPL-26 Labeling

Label is not available on this site.

03/18/1981 SUPPL-25 Labeling

Label is not available on this site.

03/18/1981 SUPPL-24 Labeling

Label is not available on this site.

11/30/1979 SUPPL-23 Manufacturing (CMC)-Formulation

Label is not available on this site.

03/18/1981 SUPPL-21 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