Details for New Drug Application (NDA): 207154
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The generic ingredient in ACZONE is dapsone. There are eight drug master file entries for this compound. Twenty-three suppliers are listed for this compound. Additional details are available on the dapsone profile page.
Summary for 207154
Tradename: | ACZONE |
Applicant: | Almirall |
Ingredient: | dapsone |
Patents: | 3 |
Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 207154
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
ACZONE | dapsone | GEL;TOPICAL | 207154 | NDA | Almirall, LLC | 16110-526 | 16110-526-30 | 1 BOTTLE, PUMP in 1 CARTON (16110-526-30) / 30 g in 1 BOTTLE, PUMP |
ACZONE | dapsone | GEL;TOPICAL | 207154 | NDA | Almirall, LLC | 16110-526 | 16110-526-60 | 1 BOTTLE, PUMP in 1 CARTON (16110-526-60) / 60 g in 1 BOTTLE, PUMP |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | GEL;TOPICAL | Strength | 7.5% | ||||
Approval Date: | Feb 24, 2016 | TE: | AB | RLD: | Yes | ||||
Patent: | ⤷ Try a Trial | Patent Expiration: | Nov 18, 2033 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Patent: | ⤷ Try a Trial | Patent Expiration: | Nov 18, 2033 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Patent: | ⤷ Try a Trial | Patent Expiration: | Nov 18, 2033 | Product Flag? | Substance Flag? | Delist Request? | |||
Patented Use: | TOPICAL TREATMENT OF ACNE VULGARIS |
Expired US Patents for NDA 207154
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Almirall | ACZONE | dapsone | GEL;TOPICAL | 207154-001 | Feb 24, 2016 | ⤷ Try a Trial | ⤷ Try a Trial |
Almirall | ACZONE | dapsone | GEL;TOPICAL | 207154-001 | Feb 24, 2016 | ⤷ Try a Trial | ⤷ Try a Trial |
Almirall | ACZONE | dapsone | GEL;TOPICAL | 207154-001 | Feb 24, 2016 | ⤷ Try a Trial | ⤷ Try a Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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