Approvals (Drugs@FDA)

SPIRONOLACTONE

HETERO LABS LTD III · SPIRONOLACTONE

ANDA218085Generic (ANDA)Prescription
Open FDA's page for this record
Application number
ANDA218085
Sponsor name
HETERO LABS LTD III
Submissions
  1. Submission type
    ORIG
    Submission number
    1
    Submission status
    AP
    Submission status date
    20250221
    Review priority
    STANDARD
    Submission class code
    UNKNOWN
Products
  1. Product number
    001
    Reference drug
    No
    Brand name
    SPIRONOLACTONE
    Reference standard
    No
    Dosage form
    SUSPENSION
    Route
    ORAL
    Marketing status
    Prescription
    Te code
    AB
    Active ingredients
    1. Name
      SPIRONOLACTONE
      Strength
      25MG/5ML
Harmonized identifiers (openFDA)
Application number
ANDA218085
Brand name
SPIRONOLACTONE
Generic name
SPIRONOLACTONE
Manufacturer name
Camber Pharmaceuticals, Inc.
Product NDC
31722-691
Product type
HUMAN PRESCRIPTION DRUG
Route
ORAL
Substance name
SPIRONOLACTONE
RxCUI
104232
SPL ID
3241a29b-82b9-fd3a-e063-6294a90aa46c
SPL set ID
4ac2926a-949a-4383-b0b0-92c0822dfcda
Package NDC
31722-691-11, 31722-691-47
Nui
N0000175557, N0000011310
Pharm class epc
Aldosterone Antagonist [EPC]
Pharm class moa
Aldosterone Antagonists [MoA]
UNII
27O7W4T232
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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.