Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

Abbreviated New Drug Application (ANDA): 204726
Company: SANDOZ INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
SILODOSIN SILODOSIN 4MG CAPSULE;ORAL Prescription AB No No
SILODOSIN SILODOSIN 8MG CAPSULE;ORAL Prescription AB 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
03/31/2017 ORIG-1 Approval STANDARD Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/204726Orig1s000ltr.pdf

SILODOSIN

CAPSULE;ORAL; 4MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
RAPAFLO SILODOSIN 4MG CAPSULE;ORAL Prescription Yes AB 022206 ALLERGAN SALES LLC
SILODOSIN SILODOSIN 4MG CAPSULE;ORAL Prescription No AB 204726 SANDOZ INC

CAPSULE;ORAL; 8MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
RAPAFLO SILODOSIN 8MG CAPSULE;ORAL Prescription Yes AB 022206 ALLERGAN SALES LLC
SILODOSIN SILODOSIN 8MG CAPSULE;ORAL Prescription No AB 204726 SANDOZ INC

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