Approvals (Drugs@FDA)

OXAZEPAM

LEADING · OXAZEPAM

ANDA218261Generic (ANDA)Prescription
Open FDA's page for this record
Application number
ANDA218261
Sponsor name
LEADING
Submissions
  1. Submission type
    ORIG
    Submission number
    1
    Submission status
    AP
    Submission status date
    20250303
    Review priority
    STANDARD
    Submission class code
    UNKNOWN
Products
  1. Product number
    002
    Reference drug
    No
    Brand name
    OXAZEPAM
    Reference standard
    No
    Dosage form
    CAPSULE
    Route
    ORAL
    Marketing status
    Prescription
    Te code
    AB
    Active ingredients
    1. Name
      OXAZEPAM
      Strength
      15MG
  2. Product number
    003
    Reference drug
    No
    Brand name
    OXAZEPAM
    Reference standard
    No
    Dosage form
    CAPSULE
    Route
    ORAL
    Marketing status
    Prescription
    Te code
    AB
    Active ingredients
    1. Name
      OXAZEPAM
      Strength
      30MG
  3. Product number
    001
    Reference drug
    No
    Brand name
    OXAZEPAM
    Reference standard
    No
    Dosage form
    CAPSULE
    Route
    ORAL
    Marketing status
    Prescription
    Te code
    AB
    Active ingredients
    1. Name
      OXAZEPAM
      Strength
      10MG
Harmonized identifiers (openFDA)
Application number
ANDA218261
Brand name
OXAZEPAM
Generic name
OXAZEPAM
Manufacturer name
Leading Pharma, LLC
Product NDC
69315-911, 69315-912, 69315-913
Product type
HUMAN PRESCRIPTION DRUG
Route
ORAL
Substance name
OXAZEPAM
RxCUI
198057, 198059, 312134
SPL ID
708e4237-a898-4d23-90b1-253c18301884
SPL set ID
67f821fa-5663-4d69-82c9-5ee13a09f324
Package NDC
69315-911-01, 69315-912-01, 69315-913-01
Nui
N0000175694, M0002356
Pharm class epc
Benzodiazepine [EPC]
Pharm class cs
Benzodiazepines [CS]
UNII
6GOW6DWN2A
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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.