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LEVALBUTEROL HYDROCHLORIDE

ANDA

LEVALBUTEROL HYDROCHLORIDE | A215217 | NEPHRON PHARMACEUTICALS CORPORATION

2 strengths0 unique patents0 unique exclusivities

API Supply Chain5 active DMFs1 inactive

5 active API suppliers hold Drug Master Files for this ingredient.

FINE CHEMICALS CORP PTY LTDLEVALBUTEROL HYDROCHLORIDE

DMF 182362005

TAPI NL BVLEVALBUTEROL HYDROCHLORIDE

DMF 184332005

CIPLA LTDLEVALBUTEROL HYDROCHLORIDE USP

DMF 191312006

SUN PHARMACEUTICAL INDUSTRIES LTDLEVALBUTEROL HYDROCHLORIDE USP

DMF 276632014

OLON SPALEVALBUTEROL HYDROCHLORIDE

DMF 280342014

FDC LTDInactiveLEVALBUTEROL HYDROCHLORIDE

DMF 213942008

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Products (2)

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#001 — EQ 0.021% BASE

0 patents0 exclusivities▴

SOLUTION;INHALATION | Approved: May 26, 2026

No patent or exclusivity listings for this strength.

#002 — EQ 0.042% BASE

0 patents0 exclusivities▾

SOLUTION;INHALATION | Approved: May 26, 2026

Change History (2)

Recent changes detected for this application.

ADDED7/1/2026

Nephron received FDA approval for levalbuterol hydrochloride under application 215217, supplement 002.

New: New record

ADDED7/1/2026

Nephron's levalbuterol hydrochloride inhalation solution (NDA 215217) received FDA approval as a new product.

New: New record