Approvals (Drugs@FDA)

LORAZEPAM

LEADING · LORAZEPAM

ANDA078203Generic (ANDA)Prescription
Open FDA's page for this record
Application number
ANDA078203
Sponsor name
LEADING
Submissions
  1. Submission type
    ORIG
    Submission number
    1
    Submission status
    AP
    Submission status date
    20070730
Products
  1. Product number
    003
    Reference drug
    No
    Brand name
    LORAZEPAM
    Reference standard
    No
    Dosage form
    TABLET
    Route
    ORAL
    Marketing status
    Prescription
    Te code
    AB
    Active ingredients
    1. Name
      LORAZEPAM
      Strength
      2MG
  2. Product number
    001
    Reference drug
    No
    Brand name
    LORAZEPAM
    Reference standard
    No
    Dosage form
    TABLET
    Route
    ORAL
    Marketing status
    Prescription
    Te code
    AB
    Active ingredients
    1. Name
      LORAZEPAM
      Strength
      0.5MG
  3. Product number
    002
    Reference drug
    No
    Brand name
    LORAZEPAM
    Reference standard
    No
    Dosage form
    TABLET
    Route
    ORAL
    Marketing status
    Prescription
    Te code
    AB
    Active ingredients
    1. Name
      LORAZEPAM
      Strength
      1MG
Harmonized identifiers (openFDA)
Application number
ANDA078203
Brand name
LORAZEPAM
Generic name
LORAZEPAM
Manufacturer name
Leading Pharma, LLC
Product NDC
69315-904, 69315-905, 69315-906
Product type
HUMAN PRESCRIPTION DRUG
Route
ORAL
Substance name
LORAZEPAM
RxCUI
197900, 197901, 197902
SPL ID
40249bb6-0d25-4b2f-aa4b-85c15af6bf8b
SPL set ID
5ca13415-4b77-4131-a9d2-6db26bc49167
Package NDC
69315-904-01, 69315-904-05, 69315-904-10, 69315-905-01, 69315-905-05, 69315-905-10, 69315-906-01, 69315-906-05, 69315-906-10
Nui
N0000175694, M0002356
Pharm class epc
Benzodiazepine [EPC]
Pharm class cs
Benzodiazepines [CS]
UNII
O26FZP769L
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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.