Teva Budesonide Formoterol ANDA 212212 Approved 23rd Apr
Summary
FDA approved Abbreviated New Drug Application (ANDA) 212212 submitted by Teva Pharms USA Inc for Budesonide and Formoterol Fumarate Dihydrate, a metered-dose inhalation aerosol. The approval covers two strength combinations: 0.08 mg/inhalation and 0.16 mg/inhalation, each with Formoterol Fumarate Dihydrate at 0.0045 mg/inhalation. Both formulations received a TE Code of AB, designating them as therapeutic equivalents to AstraZeneca's reference listed drug Symbicort (ANDA 021929).
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What changed
FDA approved ANDA 212212 for Budesonide and Formoterol Fumarate Dihydrate inhalation aerosol, granting Teva Pharms USA Inc market authorization for two dosage strengths as prescription products with TE Code AB. The products are designated therapeutic equivalents to AstraZeneca's brand-name drug Symbicort (ANDA 021929), enabling substitutability at the pharmacy level under applicable state drug substitution laws. Mylan Pharms Inc holds a third ANDA (211699, product BREYNA) in this market segment.
Pharmaceutical manufacturers and pharmacy benefit managers should monitor the entry of this Teva generic into the budesonide/formoterol inhaler market. As a therapeutic equivalent with AB-rated status, this approval increases competitive pressure on AstraZeneca's Symbicort franchise and may affect pricing and market share dynamics for existing generic and brand competitors in the respiratory combination inhaler category.
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): 212212
Company: TEVA PHARMS USA INC
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| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE | BUDESONIDE; FORMOTEROL FUMARATE DIHYDRATE | 0.08MG/INH;0.0045MG/INH | AEROSOL, METERED;INHALATION | Prescription | AB | No | No |
| BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE | BUDESONIDE; FORMOTEROL FUMARATE DIHYDRATE | 0.16MG/INH;0.0045MG/INH | AEROSOL, METERED;INHALATION | Prescription | AB | 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 |
|---|---|---|---|---|---|---|---|
| 04/23/2026 | ORIG-1 | Approval | STANDARD | Label is not available on this site. |
BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE
AEROSOL, METERED;INHALATION; 0.08MG/INH;0.0045MG/INH
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| BREYNA | BUDESONIDE; FORMOTEROL FUMARATE DIHYDRATE | 0.08MG/INH;0.0045MG/INH | AEROSOL, METERED;INHALATION | Prescription | No | AB | 211699 | MYLAN |
| BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE | BUDESONIDE; FORMOTEROL FUMARATE DIHYDRATE | 0.08MG/INH;0.0045MG/INH | AEROSOL, METERED;INHALATION | Prescription | No | AB | 212212 | TEVA PHARMS USA INC |
| SYMBICORT | BUDESONIDE; FORMOTEROL FUMARATE DIHYDRATE | 0.08MG/INH;0.0045MG/INH | AEROSOL, METERED;INHALATION | Prescription | Yes | AB | 021929 | ASTRAZENECA |
AEROSOL, METERED;INHALATION; 0.16MG/INH;0.0045MG/INH
TE Code = AB
| BREYNA | BUDESONIDE; FORMOTEROL FUMARATE DIHYDRATE | 0.16MG/INH;0.0045MG/INH | AEROSOL, METERED;INHALATION | Prescription | No | AB | 211699 | MYLAN |
| BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE | BUDESONIDE; FORMOTEROL FUMARATE DIHYDRATE | 0.16MG/INH;0.0045MG/INH | AEROSOL, METERED;INHALATION | Prescription | No | AB | 212212 | TEVA PHARMS USA INC |
| SYMBICORT | BUDESONIDE; FORMOTEROL FUMARATE DIHYDRATE | 0.16MG/INH;0.0045MG/INH | AEROSOL, METERED;INHALATION | Prescription | Yes | AB | 021929 | ASTRAZENECA |
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