Approvals (Drugs@FDA)

BUMETANIDE

ASPIRO · BUMETANIDE

ANDA218746Generic (ANDA)Prescription
Open FDA's page for this record
Application number
ANDA218746
Sponsor name
ASPIRO
Submissions
  1. Submission type
    ORIG
    Submission number
    1
    Submission status
    AP
    Submission status date
    20250227
    Review priority
    STANDARD
    Submission class code
    UNKNOWN
Products
  1. Product number
    001
    Reference drug
    No
    Brand name
    BUMETANIDE
    Reference standard
    No
    Dosage form
    INJECTABLE
    Route
    INJECTION
    Marketing status
    Prescription
    Te code
    AP
    Active ingredients
    1. Name
      BUMETANIDE
      Strength
      0.25MG/ML
Harmonized identifiers (openFDA)
Application number
ANDA218746
Brand name
BUMETANIDE
Generic name
BUMETANIDE
Manufacturer name
Camber Pharmaceuticals, Inc.
Product NDC
31722-368, 31722-369
Product type
HUMAN PRESCRIPTION DRUG
Route
INTRAMUSCULAR, INTRAVENOUS
Substance name
BUMETANIDE
RxCUI
282486, 1727569
SPL ID
32ba5fc2-0f9e-ee77-e063-6294a90af010
SPL set ID
084b34ad-36ba-43bd-a43a-1f4b4da26d8f
Package NDC
31722-368-31, 31722-368-32, 31722-369-10, 31722-369-32
Nui
N0000175366, N0000175590
Pharm class pe
Increased Diuresis at Loop of Henle [PE]
Pharm class epc
Loop Diuretic [EPC]
UNII
0Y2S3XUQ5H
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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.