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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 213683
Company: ALEMBIC

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
BREXPIPRAZOLE BREXPIPRAZOLE 0.25MG TABLET;ORAL Prescription AB No No
BREXPIPRAZOLE BREXPIPRAZOLE 0.5MG TABLET;ORAL Prescription AB No No
BREXPIPRAZOLE BREXPIPRAZOLE 1MG TABLET;ORAL Prescription AB No No
BREXPIPRAZOLE BREXPIPRAZOLE 2MG TABLET;ORAL Prescription AB No No
BREXPIPRAZOLE BREXPIPRAZOLE 3MG TABLET;ORAL Prescription AB No No
BREXPIPRAZOLE BREXPIPRAZOLE 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
01/13/2025 ORIG-1 Approval STANDARD

Label is not available on this site.

BREXPIPRAZOLE

TABLET;ORAL; 0.25MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
BREXPIPRAZOLE BREXPIPRAZOLE 0.25MG TABLET;ORAL Prescription No AB 213683 ALEMBIC
REXULTI BREXPIPRAZOLE 0.25MG TABLET;ORAL Prescription Yes AB 205422 OTSUKA

TABLET;ORAL; 0.5MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
BREXPIPRAZOLE BREXPIPRAZOLE 0.5MG TABLET;ORAL Prescription No AB 213683 ALEMBIC
REXULTI BREXPIPRAZOLE 0.5MG TABLET;ORAL Prescription Yes AB 205422 OTSUKA

TABLET;ORAL; 1MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
BREXPIPRAZOLE BREXPIPRAZOLE 1MG TABLET;ORAL Prescription No AB 213683 ALEMBIC
REXULTI BREXPIPRAZOLE 1MG TABLET;ORAL Prescription Yes AB 205422 OTSUKA

TABLET;ORAL; 2MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
BREXPIPRAZOLE BREXPIPRAZOLE 2MG TABLET;ORAL Prescription No AB 213683 ALEMBIC
REXULTI BREXPIPRAZOLE 2MG TABLET;ORAL Prescription Yes AB 205422 OTSUKA

TABLET;ORAL; 3MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
BREXPIPRAZOLE BREXPIPRAZOLE 3MG TABLET;ORAL Prescription No AB 213683 ALEMBIC
REXULTI BREXPIPRAZOLE 3MG TABLET;ORAL Prescription Yes AB 205422 OTSUKA

TABLET;ORAL; 4MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
BREXPIPRAZOLE BREXPIPRAZOLE 4MG TABLET;ORAL Prescription No AB 213683 ALEMBIC
REXULTI BREXPIPRAZOLE 4MG TABLET;ORAL Prescription Yes AB 205422 OTSUKA
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