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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 201003
Company: AJANTA PHARMA LTD
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
RISPERIDONE RISPERIDONE 0.25MG TABLET;ORAL Prescription AB No No
RISPERIDONE RISPERIDONE 0.5MG TABLET;ORAL Prescription AB No No
RISPERIDONE RISPERIDONE 1MG TABLET;ORAL Prescription AB No No
RISPERIDONE RISPERIDONE 2MG TABLET;ORAL Prescription AB No No
RISPERIDONE RISPERIDONE 3MG TABLET;ORAL Prescription AB No No
RISPERIDONE RISPERIDONE 4MG 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
08/24/2011 ORIG-1 Approval Not Applicable

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
11/12/2019 SUPPL-16 Labeling-Package Insert

Label is not available on this site.

11/12/2019 SUPPL-14 Labeling-Package Insert

Label is not available on this site.

11/12/2019 SUPPL-10 Labeling-Package Insert

Label is not available on this site.

09/08/2017 SUPPL-8 Labeling-Package Insert

Label is not available on this site.

02/01/2017 SUPPL-7 Labeling-Package Insert

Label is not available on this site.

03/17/2015 SUPPL-6 Labeling-Container/Carton Labels, Labeling-Package Insert

Label is not available on this site.

08/27/2015 SUPPL-4 Labeling-Container/Carton Labels

Label is not available on this site.

08/27/2015 SUPPL-3 Labeling-Package Insert, Labeling-Container/Carton Labels

Label is not available on this site.

12/31/2012 SUPPL-2 Labeling-Package Insert

Label is not available on this site.

07/25/2012 SUPPL-1 Labeling-Container/Carton Labels, Labeling-Package Insert

Label is not available on this site.

RISPERIDONE

TABLET;ORAL; 0.25MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
RISPERDAL RISPERIDONE 0.25MG TABLET;ORAL Prescription Yes AB 020272 JANSSEN PHARMS
RISPERIDONE RISPERIDONE 0.25MG TABLET;ORAL Prescription No AB 201003 AJANTA PHARMA LTD
RISPERIDONE RISPERIDONE 0.25MG TABLET;ORAL Prescription No AB 078071 AMNEAL
RISPERIDONE RISPERIDONE 0.25MG TABLET;ORAL Prescription No AB 077953 APOTEX INC
RISPERIDONE RISPERIDONE 0.25MG TABLET;ORAL Prescription No AB 078871 CELLTRION
RISPERIDONE RISPERIDONE 0.25MG TABLET;ORAL Prescription No AB 077543 CHARTWELL MOLECULAR
RISPERIDONE RISPERIDONE 0.25MG TABLET;ORAL Prescription No AB 076879 DR REDDYS LABS LTD
RISPERIDONE RISPERIDONE 0.25MG TABLET;ORAL Prescription No AB 077493 PRINSTON INC
RISPERIDONE RISPERIDONE 0.25MG TABLET;ORAL Prescription No AB 078707 RENATA
RISPERIDONE RISPERIDONE 0.25MG TABLET;ORAL Prescription No AB 078269 RISING
RISPERIDONE RISPERIDONE 0.25MG TABLET;ORAL Prescription No AB 078528 SANDOZ
RISPERIDONE RISPERIDONE 0.25MG TABLET;ORAL Prescription No AB 079088 TORRENT PHARMS
RISPERIDONE RISPERIDONE 0.25MG TABLET;ORAL Prescription No AB 078040 ZYDUS PHARMS USA INC

TABLET;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;ORAL Prescription Yes AB 020272 JANSSEN PHARMS
RISPERIDONE RISPERIDONE 0.5MG TABLET;ORAL Prescription No AB 201003 AJANTA PHARMA LTD
RISPERIDONE RISPERIDONE 0.5MG TABLET;ORAL Prescription No AB 078071 AMNEAL
RISPERIDONE RISPERIDONE 0.5MG TABLET;ORAL Prescription No AB 077953 APOTEX INC
RISPERIDONE RISPERIDONE 0.5MG TABLET;ORAL Prescription No AB 078871 CELLTRION
RISPERIDONE RISPERIDONE 0.5MG TABLET;ORAL Prescription No AB 077543 CHARTWELL MOLECULAR
RISPERIDONE RISPERIDONE 0.5MG TABLET;ORAL Prescription No AB 076879 DR REDDYS LABS LTD
RISPERIDONE RISPERIDONE 0.5MG TABLET;ORAL Prescription No AB 077493 PRINSTON INC
RISPERIDONE RISPERIDONE 0.5MG TABLET;ORAL Prescription No AB 078707 RENATA
RISPERIDONE RISPERIDONE 0.5MG TABLET;ORAL Prescription No AB 078269 RISING
RISPERIDONE RISPERIDONE 0.5MG TABLET;ORAL Prescription No AB 078528 SANDOZ
RISPERIDONE RISPERIDONE 0.5MG TABLET;ORAL Prescription No AB 079088 TORRENT PHARMS
RISPERIDONE RISPERIDONE 0.5MG TABLET;ORAL Prescription No AB 078040 ZYDUS PHARMS USA INC

TABLET;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;ORAL Prescription Yes AB 020272 JANSSEN PHARMS
RISPERIDONE RISPERIDONE 1MG TABLET;ORAL Prescription No AB 201003 AJANTA PHARMA LTD
RISPERIDONE RISPERIDONE 1MG TABLET;ORAL Prescription No AB 078071 AMNEAL
RISPERIDONE RISPERIDONE 1MG TABLET;ORAL Prescription No AB 077953 APOTEX INC
RISPERIDONE RISPERIDONE 1MG TABLET;ORAL Prescription No AB 078871 CELLTRION
RISPERIDONE RISPERIDONE 1MG TABLET;ORAL Prescription No AB 077543 CHARTWELL MOLECULAR
RISPERIDONE RISPERIDONE 1MG TABLET;ORAL Prescription No AB 076879 DR REDDYS LABS LTD
RISPERIDONE RISPERIDONE 1MG TABLET;ORAL Prescription No AB 077493 PRINSTON INC
RISPERIDONE RISPERIDONE 1MG TABLET;ORAL Prescription No AB 078707 RENATA
RISPERIDONE RISPERIDONE 1MG TABLET;ORAL Prescription No AB 078269 RISING
RISPERIDONE RISPERIDONE 1MG TABLET;ORAL Prescription No AB 078528 SANDOZ
RISPERIDONE RISPERIDONE 1MG TABLET;ORAL Prescription No AB 079088 TORRENT PHARMS
RISPERIDONE RISPERIDONE 1MG TABLET;ORAL Prescription No AB 078040 ZYDUS PHARMS USA INC

TABLET;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;ORAL Prescription Yes AB 020272 JANSSEN PHARMS
RISPERIDONE RISPERIDONE 2MG TABLET;ORAL Prescription No AB 201003 AJANTA PHARMA LTD
RISPERIDONE RISPERIDONE 2MG TABLET;ORAL Prescription No AB 078071 AMNEAL
RISPERIDONE RISPERIDONE 2MG TABLET;ORAL Prescription No AB 077953 APOTEX INC
RISPERIDONE RISPERIDONE 2MG TABLET;ORAL Prescription No AB 078871 CELLTRION
RISPERIDONE RISPERIDONE 2MG TABLET;ORAL Prescription No AB 077543 CHARTWELL MOLECULAR
RISPERIDONE RISPERIDONE 2MG TABLET;ORAL Prescription No AB 076879 DR REDDYS LABS LTD
RISPERIDONE RISPERIDONE 2MG TABLET;ORAL Prescription No AB 077493 PRINSTON INC
RISPERIDONE RISPERIDONE 2MG TABLET;ORAL Prescription No AB 078707 RENATA
RISPERIDONE RISPERIDONE 2MG TABLET;ORAL Prescription No AB 078269 RISING
RISPERIDONE RISPERIDONE 2MG TABLET;ORAL Prescription No AB 078528 SANDOZ
RISPERIDONE RISPERIDONE 2MG TABLET;ORAL Prescription No AB 079088 TORRENT PHARMS
RISPERIDONE RISPERIDONE 2MG TABLET;ORAL Prescription No AB 078040 ZYDUS PHARMS USA INC

TABLET;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;ORAL Prescription Yes AB 020272 JANSSEN PHARMS
RISPERIDONE RISPERIDONE 3MG TABLET;ORAL Prescription No AB 201003 AJANTA PHARMA LTD
RISPERIDONE RISPERIDONE 3MG TABLET;ORAL Prescription No AB 078071 AMNEAL
RISPERIDONE RISPERIDONE 3MG TABLET;ORAL Prescription No AB 077953 APOTEX INC
RISPERIDONE RISPERIDONE 3MG TABLET;ORAL Prescription No AB 078871 CELLTRION
RISPERIDONE RISPERIDONE 3MG TABLET;ORAL Prescription No AB 077543 CHARTWELL MOLECULAR
RISPERIDONE RISPERIDONE 3MG TABLET;ORAL Prescription No AB 076879 DR REDDYS LABS LTD
RISPERIDONE RISPERIDONE 3MG TABLET;ORAL Prescription No AB 077493 PRINSTON INC
RISPERIDONE RISPERIDONE 3MG TABLET;ORAL Prescription No AB 078707 RENATA
RISPERIDONE RISPERIDONE 3MG TABLET;ORAL Prescription No AB 078269 RISING
RISPERIDONE RISPERIDONE 3MG TABLET;ORAL Prescription No AB 078528 SANDOZ
RISPERIDONE RISPERIDONE 3MG TABLET;ORAL Prescription No AB 079088 TORRENT PHARMS
RISPERIDONE RISPERIDONE 3MG TABLET;ORAL Prescription No AB 078040 ZYDUS PHARMS USA INC

TABLET;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;ORAL Prescription Yes AB 020272 JANSSEN PHARMS
RISPERIDONE RISPERIDONE 4MG TABLET;ORAL Prescription No AB 201003 AJANTA PHARMA LTD
RISPERIDONE RISPERIDONE 4MG TABLET;ORAL Prescription No AB 078071 AMNEAL
RISPERIDONE RISPERIDONE 4MG TABLET;ORAL Prescription No AB 077953 APOTEX INC
RISPERIDONE RISPERIDONE 4MG TABLET;ORAL Prescription No AB 078871 CELLTRION
RISPERIDONE RISPERIDONE 4MG TABLET;ORAL Prescription No AB 077543 CHARTWELL MOLECULAR
RISPERIDONE RISPERIDONE 4MG TABLET;ORAL Prescription No AB 076879 DR REDDYS LABS LTD
RISPERIDONE RISPERIDONE 4MG TABLET;ORAL Prescription No AB 077493 PRINSTON INC
RISPERIDONE RISPERIDONE 4MG TABLET;ORAL Prescription No AB 078707 RENATA
RISPERIDONE RISPERIDONE 4MG TABLET;ORAL Prescription No AB 078269 RISING
RISPERIDONE RISPERIDONE 4MG TABLET;ORAL Prescription No AB 078528 SANDOZ
RISPERIDONE RISPERIDONE 4MG TABLET;ORAL Prescription No AB 079088 TORRENT PHARMS
RISPERIDONE RISPERIDONE 4MG TABLET;ORAL Prescription No AB 078040 ZYDUS PHARMS USA INC
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