Albuterol Sulfate Inhalation Aerosol ANDA 219409 Approved for Cipla
Summary
The FDA granted approval for ANDA 219409 submitted by Cipla for Albuterol Sulfate (EQ 0.09mg base/inhalation) as a metered-dose inhalation aerosol. The application was approved on April 22, 2026 under ORIG-1 submission with STANDARD review classification. The approved product holds TE Code AB3, indicating therapeutic equivalence to the reference listed drug VENTOLIN HFA (GlaxoSmithKline, ANDA 020983), and has been assigned Prescription marketing status.
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GovPing monitors FDA Drugs@FDA - New Applications and Actions for new healthcare & life sciences regulatory changes. Every update since tracking began is archived, classified, and available as free RSS or email alerts — 14 changes logged to date.
What changed
The FDA has approved Abbreviated New Drug Application (ANDA) 219409 for Albuterol Sulfate metered-dose inhalation aerosol (EQ 0.09mg base/inhalation) submitted by Cipla. This original approval action was taken on April 22, 2026 under standard review classification. The approved generic drug holds therapeutic equivalence code AB3, signifying it is therapeutically equivalent to the reference listed drug VENTOLIN HFA marketed by GlaxoSmithKline.
Pharmaceutical companies and healthcare providers should note that Cipla is now authorized to market this generic albuterol inhaler in the United States as a prescription-only product. The therapeutic equivalence designation means the generic is expected to perform the same as the reference product. This approval affects the competitive landscape for short-acting beta-agonist inhalers used in respiratory therapy.
Archived snapshot
Apr 27, 2026GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.
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Abbreviated New Drug Application (ANDA): 219409
Company: CIPLA
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| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ALBUTEROL SULFATE | ALBUTEROL SULFATE | EQ 0.09MG BASE/INH | AEROSOL, METERED;INHALATION | Prescription | AB3 | No | No |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 04/22/2026 | ORIG-1 | Approval | STANDARD | Label is not available on this site. |
ALBUTEROL SULFATE
AEROSOL, METERED;INHALATION; EQ 0.09MG BASE/INH
TE Code = AB3
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| ALBUTEROL SULFATE | ALBUTEROL SULFATE | EQ 0.09MG BASE/INH | AEROSOL, METERED;INHALATION | Prescription | No | AB3 | 219409 | CIPLA |
| VENTOLIN HFA | ALBUTEROL SULFATE | EQ 0.09MG BASE/INH | AEROSOL, METERED;INHALATION | Prescription | Yes | AB3 | 020983 | GLAXOSMITHKLINE |
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