Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

Abbreviated New Drug Application (ANDA): 078725
Company: MYLAN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
GRANISETRON HYDROCHLORIDE GRANISETRON HYDROCHLORIDE EQ 1MG BASE TABLET;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
01/30/2008 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
09/18/2014 SUPPL-5 Labeling-Package Insert

Label is not available on this site.

09/17/2010 SUPPL-2 Labeling-Package Insert, Labeling-Container/Carton Labels

Label is not available on this site.

GRANISETRON HYDROCHLORIDE

TABLET;ORAL; EQ 1MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
GRANISETRON HYDROCHLORIDE GRANISETRON HYDROCHLORIDE EQ 1MG BASE TABLET;ORAL Prescription No AB 078843 APOTEX INC
GRANISETRON HYDROCHLORIDE GRANISETRON HYDROCHLORIDE EQ 1MG BASE TABLET;ORAL Prescription No AB 078037 CHARTWELL MOLECULAR
GRANISETRON HYDROCHLORIDE GRANISETRON HYDROCHLORIDE EQ 1MG BASE TABLET;ORAL Prescription No AB 078846 DR REDDYS LABS LTD
GRANISETRON HYDROCHLORIDE GRANISETRON HYDROCHLORIDE EQ 1MG BASE TABLET;ORAL Prescription No AB 078725 MYLAN
GRANISETRON HYDROCHLORIDE GRANISETRON HYDROCHLORIDE EQ 1MG BASE TABLET;ORAL Prescription No AB 078969 NATCO PHARMA
GRANISETRON HYDROCHLORIDE GRANISETRON HYDROCHLORIDE EQ 1MG BASE TABLET;ORAL Prescription No AB 078678 ORCHID HLTHCARE
GRANISETRON HYDROCHLORIDE GRANISETRON HYDROCHLORIDE EQ 1MG BASE TABLET;ORAL Prescription No AB 090817 TARO PHARM
GRANISETRON HYDROCHLORIDE GRANISETRON HYDROCHLORIDE EQ 1MG BASE TABLET;ORAL Prescription No AB 077842 WEST-WARD PHARMS INT

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