Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 077328
Company: DR REDDYS LABS LTD
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
RISPERIDONE RISPERIDONE 0.5MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription AB No No
RISPERIDONE RISPERIDONE 1MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription AB No No
RISPERIDONE RISPERIDONE 2MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription AB No No
RISPERIDONE RISPERIDONE 3MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription AB No No
RISPERIDONE RISPERIDONE 4MG TABLET, ORALLY DISINTEGRATING;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
02/24/2009 ORIG-1 Approval Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/077328ls000lb.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
12/20/2012 SUPPL-10 Labeling-Container/Carton Labels, Labeling-Package Insert

Label is not available on this site.

04/30/2012 SUPPL-9 Labeling-Package Insert

Label is not available on this site.

07/25/2012 SUPPL-8 Labeling-Package Insert

Label is not available on this site.

10/26/2011 SUPPL-7 Labeling-Container/Carton Labels, Labeling-Package Insert

Label is not available on this site.

08/09/2011 SUPPL-6 Labeling-Package Insert

Label is not available on this site.

05/27/2011 SUPPL-5 Labeling-Package Insert

Label is not available on this site.

12/29/2010 SUPPL-4 Labeling-Package Insert

Label is not available on this site.

11/30/2009 SUPPL-3 Manufacturing (CMC)-New Strength

Label is not available on this site.

10/05/2009 SUPPL-2 Labeling-Patient Package Insert

Label is not available on this site.

08/24/2009 SUPPL-1 Labeling-Patient Package Insert

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
02/24/2009 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/077328ls000lb.pdf

RISPERIDONE

TABLET, ORALLY DISINTEGRATING;ORAL; 0.5MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
RISPERDAL RISPERIDONE 0.5MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription Yes AB 021444 JANSSEN PHARMS
RISPERIDONE RISPERIDONE 0.5MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 076996 ACTAVIS LABS FL INC
RISPERIDONE RISPERIDONE 0.5MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 077328 DR REDDYS LABS LTD
RISPERIDONE RISPERIDONE 0.5MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 090839 JUBILANT GENERICS
RISPERIDONE RISPERIDONE 0.5MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 077494 PAR PHARM
RISPERIDONE RISPERIDONE 0.5MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 078116 SANDOZ
RISPERIDONE RISPERIDONE 0.5MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 077542 SUN PHARM INDS LTD
RISPERIDONE RISPERIDONE 0.5MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 078464 SUN PHARM INDS LTD
RISPERIDONE RISPERIDONE 0.5MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 076908 TEVA
RISPERIDONE RISPERIDONE 0.5MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 078516 ZYDUS PHARMS USA

TABLET, ORALLY DISINTEGRATING;ORAL; 1MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
RISPERDAL RISPERIDONE 1MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription Yes AB 021444 JANSSEN PHARMS
RISPERIDONE RISPERIDONE 1MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 076996 ACTAVIS LABS FL INC
RISPERIDONE RISPERIDONE 1MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 077328 DR REDDYS LABS LTD
RISPERIDONE RISPERIDONE 1MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 090839 JUBILANT GENERICS
RISPERIDONE RISPERIDONE 1MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 077494 PAR PHARM
RISPERIDONE RISPERIDONE 1MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 078116 SANDOZ
RISPERIDONE RISPERIDONE 1MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 077542 SUN PHARM INDS LTD
RISPERIDONE RISPERIDONE 1MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 078464 SUN PHARM INDS LTD
RISPERIDONE RISPERIDONE 1MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 076908 TEVA

TABLET, ORALLY DISINTEGRATING;ORAL; 2MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
RISPERDAL RISPERIDONE 2MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription Yes AB 021444 JANSSEN PHARMS
RISPERIDONE RISPERIDONE 2MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 076996 ACTAVIS LABS FL INC
RISPERIDONE RISPERIDONE 2MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 077328 DR REDDYS LABS LTD
RISPERIDONE RISPERIDONE 2MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 090839 JUBILANT GENERICS
RISPERIDONE RISPERIDONE 2MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 077494 PAR PHARM
RISPERIDONE RISPERIDONE 2MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 078116 SANDOZ
RISPERIDONE RISPERIDONE 2MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 077542 SUN PHARM INDS LTD
RISPERIDONE RISPERIDONE 2MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 078464 SUN PHARM INDS LTD
RISPERIDONE RISPERIDONE 2MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 076908 TEVA
RISPERIDONE RISPERIDONE 2MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 078516 ZYDUS PHARMS USA

TABLET, ORALLY DISINTEGRATING;ORAL; 3MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
RISPERDAL RISPERIDONE 3MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription Yes AB 021444 JANSSEN PHARMS
RISPERIDONE RISPERIDONE 3MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 076996 ACTAVIS LABS FL INC
RISPERIDONE RISPERIDONE 3MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 077328 DR REDDYS LABS LTD
RISPERIDONE RISPERIDONE 3MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 090839 JUBILANT GENERICS
RISPERIDONE RISPERIDONE 3MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 077494 PAR PHARM
RISPERIDONE RISPERIDONE 3MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 078116 SANDOZ
RISPERIDONE RISPERIDONE 3MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 078464 SUN PHARM INDS LTD
RISPERIDONE RISPERIDONE 3MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 078474 SUN PHARM INDS LTD

TABLET, ORALLY DISINTEGRATING;ORAL; 4MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
RISPERDAL RISPERIDONE 4MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription Yes AB 021444 JANSSEN PHARMS
RISPERIDONE RISPERIDONE 4MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 076996 ACTAVIS LABS FL INC
RISPERIDONE RISPERIDONE 4MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 077328 DR REDDYS LABS LTD
RISPERIDONE RISPERIDONE 4MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 090839 JUBILANT GENERICS
RISPERIDONE RISPERIDONE 4MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 077494 PAR PHARM
RISPERIDONE RISPERIDONE 4MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 078116 SANDOZ
RISPERIDONE RISPERIDONE 4MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 078464 SUN PHARM INDS LTD
RISPERIDONE RISPERIDONE 4MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 078474 SUN PHARM INDS LTD

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