Approvals (Drugs@FDA)

ALBUTEROL SULFATE

ARMSTRONG PHARMS · ALBUTEROL SULFATE

ANDA212447Generic (ANDA)Prescription
Open FDA's page for this record
Application number
ANDA212447
Sponsor name
ARMSTRONG PHARMS
Submissions
  1. Submission type
    ORIG
    Submission number
    1
    Submission status
    AP
    Submission status date
    20240521
    Review priority
    STANDARD
    Submission class code
    UNKNOWN
Products
  1. Product number
    001
    Reference drug
    No
    Brand name
    ALBUTEROL SULFATE
    Reference standard
    No
    Dosage form
    AEROSOL, METERED
    Route
    INHALATION
    Marketing status
    Prescription
    Te code
    AB2
    Active ingredients
    1. Name
      ALBUTEROL SULFATE
      Strength
      EQ 0.09MG BASE/INH
Harmonized identifiers (openFDA)
Application number
ANDA212447
Brand name
ALBUTEROL SULFATE
Generic name
ALBUTEROL SULFATE
Manufacturer name
Armstrong Pharmaceuticals, Inc.
Product NDC
17270-0740
Product type
HUMAN PRESCRIPTION DRUG
Route
RESPIRATORY (INHALATION)
Substance name
ALBUTEROL SULFATE
RxCUI
2123072
SPL ID
aabe1b11-7f84-4db3-9d05-0c79a4a88ba2
SPL set ID
17858afa-dcdf-4612-b475-3b6baadfb639
Package NDC
17270-0740-0
UNII
021SEF3731
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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.