Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

Abbreviated New Drug Application (ANDA): 078909
Company: BIO PHARM INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
RISPERIDONE RISPERIDONE 1MG/ML SOLUTION;ORAL Prescription AA 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
07/29/2009 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
03/01/2012 SUPPL-9 Labeling-Package Insert

Label is not available on this site.

11/10/2011 SUPPL-8 Labeling-Package Insert

Label is not available on this site.

11/10/2011 SUPPL-7 Labeling-Container/Carton Labels, Labeling-Package Insert

Label is not available on this site.

11/10/2011 SUPPL-6 Labeling-Package Insert

Label is not available on this site.

04/25/2011 SUPPL-3 Labeling-Package Insert

Label is not available on this site.

01/11/2011 SUPPL-2 Labeling-Package Insert

Label is not available on this site.

RISPERIDONE

SOLUTION;ORAL; 1MG/ML
TE Code = AA

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
RISPERDAL RISPERIDONE 1MG/ML SOLUTION;ORAL Prescription Yes AA 020588 JANSSEN PHARMS
RISPERIDONE RISPERIDONE 1MG/ML SOLUTION;ORAL Prescription No AA 091384 AMNEAL PHARMS
RISPERIDONE RISPERIDONE 1MG/ML SOLUTION;ORAL Prescription No AA 076440 ANI PHARMS INC
RISPERIDONE RISPERIDONE 1MG/ML SOLUTION;ORAL Prescription No AA 077719 APOTEX INC
RISPERIDONE RISPERIDONE 1MG/ML SOLUTION;ORAL Prescription No AA 078452 AUROBINDO PHARMA LTD
RISPERIDONE RISPERIDONE 1MG/ML SOLUTION;ORAL Prescription No AA 078909 BIO PHARM INC
RISPERIDONE RISPERIDONE 1MG/ML SOLUTION;ORAL Prescription No AA 079158 LANNETT CO INC
RISPERIDONE RISPERIDONE 1MG/ML SOLUTION;ORAL Prescription No AA 090347 TARO
RISPERIDONE RISPERIDONE 1MG/ML SOLUTION;ORAL Prescription No AA 079059 TRIS PHARMA INC
RISPERIDONE RISPERIDONE 1MG/ML SOLUTION;ORAL Prescription No AA 076904 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