Details for New Drug Application (NDA): 214418
The generic ingredient in BECLOMETHASONE DIPROPIONATE is beclomethasone dipropionate. There is one drug master file entry for this compound. Four suppliers are listed for this compound. Additional details are available on the beclomethasone dipropionate profile page.
Summary for 214418
| Tradename: | BECLOMETHASONE DIPROPIONATE |
| Applicant: | Aurolife Pharma Llc |
| Ingredient: | beclomethasone dipropionate |
| Patents: | 0 |
Pharmacology for NDA: 214418
| Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
Suppliers and Packaging for NDA: 214418
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| BECLOMETHASONE DIPROPIONATE | beclomethasone dipropionate | AEROSOL, METERED;INHALATION | 214418 | ANDA | Aurolife Pharma LLC | 13107-230 | 13107-230-54 | 1 CANISTER in 1 CARTON (13107-230-54) / 120 AEROSOL, METERED in 1 CANISTER |
| BECLOMETHASONE DIPROPIONATE | beclomethasone dipropionate | AEROSOL, METERED;INHALATION | 214418 | ANDA | Aurolife Pharma LLC | 13107-231 | 13107-231-54 | 1 CANISTER in 1 CARTON (13107-231-54) / 120 AEROSOL, METERED in 1 CANISTER |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | AEROSOL, METERED;INHALATION | Strength | 0.04MG/INH | ||||
| Approval Date: | Sep 14, 2026 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | AEROSOL, METERED;INHALATION | Strength | 0.08MG/INH | ||||
| Approval Date: | Sep 14, 2026 | TE: | AB | RLD: | No | ||||
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