Approvals (Drugs@FDA)

CLOBAZAM

HETERO LABS LTD III · CLOBAZAM

ANDA209796Generic (ANDA)Prescription
Open FDA's page for this record
Application number
ANDA209796
Sponsor name
HETERO LABS LTD III
Submissions
  1. Submission type
    ORIG
    Submission number
    1
    Submission status
    AP
    Submission status date
    20200224
    Review priority
    STANDARD
    Submission class code
    UNKNOWN
  2. Submission type
    SUPPL
    Submission number
    2
    Submission status
    AP
    Submission status date
    20230512
    Review priority
    STANDARD
    Submission class code
    LABELING
    Submission class code description
    Labeling
  3. Submission type
    SUPPL
    Submission number
    3
    Submission status
    AP
    Submission status date
    20240531
    Review priority
    STANDARD
    Submission class code
    LABELING
    Submission class code description
    Labeling
  4. Submission type
    SUPPL
    Submission number
    1
    Submission status
    AP
    Submission status date
    20211020
    Review priority
    STANDARD
    Submission class code
    LABELING
    Submission class code description
    Labeling
Products
  1. Product number
    001
    Reference drug
    No
    Brand name
    CLOBAZAM
    Reference standard
    No
    Dosage form
    SUSPENSION
    Route
    ORAL
    Marketing status
    Prescription
    Te code
    AB
    Active ingredients
    1. Name
      CLOBAZAM
      Strength
      2.5MG/ML
Harmonized identifiers (openFDA)
Application number
ANDA209796
Brand name
CLOBAZAM
Generic name
CLOBAZAM
Manufacturer name
NorthStar RxLLC, Camber Pharmaceuticals, Inc.
Product NDC
16714-087, 31722-641
Product type
HUMAN PRESCRIPTION DRUG
Route
ORAL
Substance name
CLOBAZAM
RxCUI
1366192
SPL ID
f649cb16-8cb4-5292-e053-2995a90a04fc, 556132d3-7f61-e679-e063-6394a90a4528
SPL set ID
574a3f91-d73e-46bc-b4a1-2388439521fb, c9b51794-3cfa-4a34-b5bb-d523b5798c17
Package NDC
16714-087-01, 31722-641-12
Nui
N0000175694, M0002356, N0000182137, N0000185506
Pharm class epc
Benzodiazepine [EPC]
Pharm class cs
Benzodiazepines [CS]
Pharm class moa
Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A4 Inducers [MoA]
UNII
2MRO291B4U
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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.