Approvals (Drugs@FDA)

ISOPROTERENOL HYDROCHLORIDE

EUGIA PHARMA · ISOPROTERENOL HYDROCHLORIDE

ANDA211864Generic (ANDA)Discontinued
Open FDA's page for this record
Application number
ANDA211864
Sponsor name
EUGIA PHARMA
Submissions
  1. Submission type
    ORIG
    Submission number
    1
    Submission status
    AP
    Submission status date
    20210209
    Review priority
    STANDARD
    Submission class code
    UNKNOWN
  2. Submission type
    SUPPL
    Submission number
    2
    Submission status
    AP
    Submission status date
    20260825
    Review priority
    STANDARD
    Submission class code
    LABELING
    Submission class code description
    Labeling
Products
  1. Product number
    001
    Reference drug
    No
    Brand name
    ISOPROTERENOL HYDROCHLORIDE
    Reference standard
    No
    Dosage form
    INJECTABLE
    Route
    INJECTION
    Marketing status
    Discontinued
    Te code
    AP
    Active ingredients
    1. Name
      ISOPROTERENOL HYDROCHLORIDE
      Strength
      0.2MG/ML
Harmonized identifiers (openFDA)
Application number
ANDA211864
Brand name
ISOPROTERENOL HYDROCHLORIDE
Generic name
ISOPROTERENOL HYDROCHLORIDE
Manufacturer name
Eugia US LLC
Product NDC
55150-316, 55150-317
Product type
HUMAN PRESCRIPTION DRUG
Route
INTRACARDIAC, INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS
Substance name
ISOPROTERENOL HYDROCHLORIDE
RxCUI
1667909, 1667915
SPL ID
a2c8dee4-69b8-479b-a203-25fdd0c234f1
SPL set ID
3e4050e8-7d94-4ed7-951d-1ff818ddadf1
Package NDC
55150-316-01, 55150-316-25, 55150-317-01, 55150-317-10
UNII
DIA2A74855
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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.