Approvals (Drugs@FDA)

BRIVARACETAM

AUROBINDO PHARMA · BRIVARACETAM

ANDA220288Generic (ANDA)Prescription
Open FDA's page for this record
Application number
ANDA220288
Sponsor name
AUROBINDO PHARMA
Submissions
  1. Submission type
    ORIG
    Submission number
    1
    Submission status
    AP
    Submission status date
    20260810
    Review priority
    STANDARD
    Submission class code
    UNKNOWN
Products
  1. Product number
    001
    Reference drug
    No
    Brand name
    BRIVARACETAM
    Reference standard
    No
    Dosage form
    SOLUTION
    Route
    ORAL
    Marketing status
    Prescription
    Te code
    AA
    Active ingredients
    1. Name
      BRIVARACETAM
      Strength
      10MG/ML
Harmonized identifiers (openFDA)
Application number
ANDA220288
Brand name
BRIVARACETAM
Generic name
BRIVARACETAM
Manufacturer name
Aurobindo Pharma Limited
Product NDC
59651-995
Product type
HUMAN PRESCRIPTION DRUG
Route
ORAL
Substance name
BRIVARACETAM
RxCUI
1739785
SPL ID
bd0525ad-75ee-4870-8e88-db05b3aae880
SPL set ID
57cfb2c3-395d-0892-e063-6294a90a1064
Package NDC
59651-995-03
Nui
N0000192345
Pharm class moa
Epoxide Hydrolase Inhibitors [MoA]
UNII
U863JGG2IA
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Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.