Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 204111
Company: MACLEODS PHARMS LTD
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ARIPIPRAZOLE ARIPIPRAZOLE 2MG TABLET;ORAL Prescription AB No No
ARIPIPRAZOLE ARIPIPRAZOLE 5MG TABLET;ORAL Prescription AB No No
ARIPIPRAZOLE ARIPIPRAZOLE 10MG TABLET;ORAL Prescription AB No No
ARIPIPRAZOLE ARIPIPRAZOLE 15MG TABLET;ORAL Prescription AB No No
ARIPIPRAZOLE ARIPIPRAZOLE 20MG TABLET;ORAL Prescription AB No No
ARIPIPRAZOLE ARIPIPRAZOLE 30MG 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
10/07/2016 ORIG-1 Approval

Label is not available on this site.

ARIPIPRAZOLE

TABLET;ORAL; 2MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ABILIFY ARIPIPRAZOLE 2MG TABLET;ORAL Prescription Yes AB 021436 OTSUKA
ARIPIPRAZOLE ARIPIPRAZOLE 2MG TABLET;ORAL Prescription No AB 206251 ACCORD HLTHCARE
ARIPIPRAZOLE ARIPIPRAZOLE 2MG TABLET;ORAL Prescription No AB 206174 AJANTA PHARMA LTD
ARIPIPRAZOLE ARIPIPRAZOLE 2MG TABLET;ORAL Prescription No AB 202101 ALEMBIC PHARMS LTD
ARIPIPRAZOLE ARIPIPRAZOLE 2MG TABLET;ORAL Prescription No AB 204838 AMNEAL PHARMS
ARIPIPRAZOLE ARIPIPRAZOLE 2MG TABLET;ORAL Prescription No AB 078583 APOTEX INC
ARIPIPRAZOLE ARIPIPRAZOLE 2MG TABLET;ORAL Prescription No AB 203908 AUROBINDO PHARMA LTD
ARIPIPRAZOLE ARIPIPRAZOLE 2MG TABLET;ORAL Prescription No AB 205064 HETERO LABS LTD V
ARIPIPRAZOLE ARIPIPRAZOLE 2MG TABLET;ORAL Prescription No AB 204111 MACLEODS PHARMS LTD
ARIPIPRAZOLE ARIPIPRAZOLE 2MG TABLET;ORAL Prescription No AB 202683 ORCHID HLTHCARE
ARIPIPRAZOLE ARIPIPRAZOLE 2MG TABLET;ORAL Prescription No AB 091279 SANTOS BIOTECH
ARIPIPRAZOLE ARIPIPRAZOLE 2MG TABLET;ORAL Prescription No AB 206383 SCIEGEN PHARMS INC
ARIPIPRAZOLE ARIPIPRAZOLE 2MG TABLET;ORAL Prescription No AB 078607 TEVA PHARMS USA
ARIPIPRAZOLE ARIPIPRAZOLE 2MG TABLET;ORAL Prescription No AB 201519 TORRENT PHARMS LTD

TABLET;ORAL; 5MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ABILIFY ARIPIPRAZOLE 5MG TABLET;ORAL Prescription Yes AB 021436 OTSUKA
ARIPIPRAZOLE ARIPIPRAZOLE 5MG TABLET;ORAL Prescription No AB 206251 ACCORD HLTHCARE
ARIPIPRAZOLE ARIPIPRAZOLE 5MG TABLET;ORAL Prescription No AB 206174 AJANTA PHARMA LTD
ARIPIPRAZOLE ARIPIPRAZOLE 5MG TABLET;ORAL Prescription No AB 202101 ALEMBIC PHARMS LTD
ARIPIPRAZOLE ARIPIPRAZOLE 5MG TABLET;ORAL Prescription No AB 204838 AMNEAL PHARMS
ARIPIPRAZOLE ARIPIPRAZOLE 5MG TABLET;ORAL Prescription No AB 078583 APOTEX INC
ARIPIPRAZOLE ARIPIPRAZOLE 5MG TABLET;ORAL Prescription No AB 203908 AUROBINDO PHARMA LTD
ARIPIPRAZOLE ARIPIPRAZOLE 5MG TABLET;ORAL Prescription No AB 205064 HETERO LABS LTD V
ARIPIPRAZOLE ARIPIPRAZOLE 5MG TABLET;ORAL Prescription No AB 204111 MACLEODS PHARMS LTD
ARIPIPRAZOLE ARIPIPRAZOLE 5MG TABLET;ORAL Prescription No AB 202683 ORCHID HLTHCARE
ARIPIPRAZOLE ARIPIPRAZOLE 5MG TABLET;ORAL Prescription No AB 091279 SANTOS BIOTECH
ARIPIPRAZOLE ARIPIPRAZOLE 5MG TABLET;ORAL Prescription No AB 206383 SCIEGEN PHARMS INC
ARIPIPRAZOLE ARIPIPRAZOLE 5MG TABLET;ORAL Prescription No AB 078607 TEVA PHARMS USA
ARIPIPRAZOLE ARIPIPRAZOLE 5MG TABLET;ORAL Prescription No AB 201519 TORRENT PHARMS LTD

TABLET;ORAL; 10MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ABILIFY ARIPIPRAZOLE 10MG TABLET;ORAL Prescription Yes AB 021436 OTSUKA
ARIPIPRAZOLE ARIPIPRAZOLE 10MG TABLET;ORAL Prescription No AB 206251 ACCORD HLTHCARE
ARIPIPRAZOLE ARIPIPRAZOLE 10MG TABLET;ORAL Prescription No AB 206174 AJANTA PHARMA LTD
ARIPIPRAZOLE ARIPIPRAZOLE 10MG TABLET;ORAL Prescription No AB 202101 ALEMBIC PHARMS LTD
ARIPIPRAZOLE ARIPIPRAZOLE 10MG TABLET;ORAL Prescription No AB 204838 AMNEAL PHARMS
ARIPIPRAZOLE ARIPIPRAZOLE 10MG TABLET;ORAL Prescription No AB 078583 APOTEX INC
ARIPIPRAZOLE ARIPIPRAZOLE 10MG TABLET;ORAL Prescription No AB 203908 AUROBINDO PHARMA LTD
ARIPIPRAZOLE ARIPIPRAZOLE 10MG TABLET;ORAL Prescription No AB 205064 HETERO LABS LTD V
ARIPIPRAZOLE ARIPIPRAZOLE 10MG TABLET;ORAL Prescription No AB 204111 MACLEODS PHARMS LTD
ARIPIPRAZOLE ARIPIPRAZOLE 10MG TABLET;ORAL Prescription No AB 202683 ORCHID HLTHCARE
ARIPIPRAZOLE ARIPIPRAZOLE 10MG TABLET;ORAL Prescription No AB 091279 SANTOS BIOTECH
ARIPIPRAZOLE ARIPIPRAZOLE 10MG TABLET;ORAL Prescription No AB 206383 SCIEGEN PHARMS INC
ARIPIPRAZOLE ARIPIPRAZOLE 10MG TABLET;ORAL Prescription No AB 078608 TEVA PHARMS USA
ARIPIPRAZOLE ARIPIPRAZOLE 10MG TABLET;ORAL Prescription No AB 201519 TORRENT PHARMS LTD

TABLET;ORAL; 15MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ABILIFY ARIPIPRAZOLE 15MG TABLET;ORAL Prescription Yes AB 021436 OTSUKA
ARIPIPRAZOLE ARIPIPRAZOLE 15MG TABLET;ORAL Prescription No AB 206251 ACCORD HLTHCARE
ARIPIPRAZOLE ARIPIPRAZOLE 15MG TABLET;ORAL Prescription No AB 206174 AJANTA PHARMA LTD
ARIPIPRAZOLE ARIPIPRAZOLE 15MG TABLET;ORAL Prescription No AB 202101 ALEMBIC PHARMS LTD
ARIPIPRAZOLE ARIPIPRAZOLE 15MG TABLET;ORAL Prescription No AB 204838 AMNEAL PHARMS
ARIPIPRAZOLE ARIPIPRAZOLE 15MG TABLET;ORAL Prescription No AB 078583 APOTEX INC
ARIPIPRAZOLE ARIPIPRAZOLE 15MG TABLET;ORAL Prescription No AB 203908 AUROBINDO PHARMA LTD
ARIPIPRAZOLE ARIPIPRAZOLE 15MG TABLET;ORAL Prescription No AB 205064 HETERO LABS LTD V
ARIPIPRAZOLE ARIPIPRAZOLE 15MG TABLET;ORAL Prescription No AB 204111 MACLEODS PHARMS LTD
ARIPIPRAZOLE ARIPIPRAZOLE 15MG TABLET;ORAL Prescription No AB 202683 ORCHID HLTHCARE
ARIPIPRAZOLE ARIPIPRAZOLE 15MG TABLET;ORAL Prescription No AB 091279 SANTOS BIOTECH
ARIPIPRAZOLE ARIPIPRAZOLE 15MG TABLET;ORAL Prescription No AB 206383 SCIEGEN PHARMS INC
ARIPIPRAZOLE ARIPIPRAZOLE 15MG TABLET;ORAL Prescription No AB 078708 TEVA PHARMS USA
ARIPIPRAZOLE ARIPIPRAZOLE 15MG TABLET;ORAL Prescription No AB 201519 TORRENT PHARMS LTD

TABLET;ORAL; 20MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ABILIFY ARIPIPRAZOLE 20MG TABLET;ORAL Prescription Yes AB 021436 OTSUKA
ARIPIPRAZOLE ARIPIPRAZOLE 20MG TABLET;ORAL Prescription No AB 206251 ACCORD HLTHCARE
ARIPIPRAZOLE ARIPIPRAZOLE 20MG TABLET;ORAL Prescription No AB 206174 AJANTA PHARMA LTD
ARIPIPRAZOLE ARIPIPRAZOLE 20MG TABLET;ORAL Prescription No AB 202101 ALEMBIC PHARMS LTD
ARIPIPRAZOLE ARIPIPRAZOLE 20MG TABLET;ORAL Prescription No AB 204838 AMNEAL PHARMS
ARIPIPRAZOLE ARIPIPRAZOLE 20MG TABLET;ORAL Prescription No AB 078583 APOTEX INC
ARIPIPRAZOLE ARIPIPRAZOLE 20MG TABLET;ORAL Prescription No AB 203908 AUROBINDO PHARMA LTD
ARIPIPRAZOLE ARIPIPRAZOLE 20MG TABLET;ORAL Prescription No AB 205064 HETERO LABS LTD V
ARIPIPRAZOLE ARIPIPRAZOLE 20MG TABLET;ORAL Prescription No AB 204111 MACLEODS PHARMS LTD
ARIPIPRAZOLE ARIPIPRAZOLE 20MG TABLET;ORAL Prescription No AB 202683 ORCHID HLTHCARE
ARIPIPRAZOLE ARIPIPRAZOLE 20MG TABLET;ORAL Prescription No AB 091279 SANTOS BIOTECH
ARIPIPRAZOLE ARIPIPRAZOLE 20MG TABLET;ORAL Prescription No AB 206383 SCIEGEN PHARMS INC
ARIPIPRAZOLE ARIPIPRAZOLE 20MG TABLET;ORAL Prescription No AB 078708 TEVA PHARMS USA
ARIPIPRAZOLE ARIPIPRAZOLE 20MG TABLET;ORAL Prescription No AB 201519 TORRENT PHARMS LTD

TABLET;ORAL; 30MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ABILIFY ARIPIPRAZOLE 30MG TABLET;ORAL Prescription Yes AB 021436 OTSUKA
ARIPIPRAZOLE ARIPIPRAZOLE 30MG TABLET;ORAL Prescription No AB 206251 ACCORD HLTHCARE
ARIPIPRAZOLE ARIPIPRAZOLE 30MG TABLET;ORAL Prescription No AB 206174 AJANTA PHARMA LTD
ARIPIPRAZOLE ARIPIPRAZOLE 30MG TABLET;ORAL Prescription No AB 202101 ALEMBIC PHARMS LTD
ARIPIPRAZOLE ARIPIPRAZOLE 30MG TABLET;ORAL Prescription No AB 204838 AMNEAL PHARMS
ARIPIPRAZOLE ARIPIPRAZOLE 30MG TABLET;ORAL Prescription No AB 078583 APOTEX INC
ARIPIPRAZOLE ARIPIPRAZOLE 30MG TABLET;ORAL Prescription No AB 203908 AUROBINDO PHARMA LTD
ARIPIPRAZOLE ARIPIPRAZOLE 30MG TABLET;ORAL Prescription No AB 205064 HETERO LABS LTD V
ARIPIPRAZOLE ARIPIPRAZOLE 30MG TABLET;ORAL Prescription No AB 204111 MACLEODS PHARMS LTD
ARIPIPRAZOLE ARIPIPRAZOLE 30MG TABLET;ORAL Prescription No AB 202683 ORCHID HLTHCARE
ARIPIPRAZOLE ARIPIPRAZOLE 30MG TABLET;ORAL Prescription No AB 091279 SANTOS BIOTECH
ARIPIPRAZOLE ARIPIPRAZOLE 30MG TABLET;ORAL Prescription No AB 206383 SCIEGEN PHARMS INC
ARIPIPRAZOLE ARIPIPRAZOLE 30MG TABLET;ORAL Prescription No AB 078708 TEVA PHARMS USA
ARIPIPRAZOLE ARIPIPRAZOLE 30MG TABLET;ORAL Prescription No AB 201519 TORRENT PHARMS LTD

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