Details for New Drug Application (NDA): 021794
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The generic ingredient in ACZONE is dapsone. There are eight drug master file entries for this compound. Twenty-seven suppliers are listed for this compound. Additional details are available on the dapsone profile page.
Suppliers and Packaging for NDA: 021794
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
ACZONE | dapsone | GEL;TOPICAL | 021794 | NDA | Allergan, Inc. | 0023-3670 | 0023-3670-03 | 15 TUBE in 1 CARTON (0023-3670-03) / 3 g in 1 TUBE |
ACZONE | dapsone | GEL;TOPICAL | 021794 | NDA | Allergan, Inc. | 0023-3670 | 0023-3670-30 | 1 TUBE in 1 CARTON (0023-3670-30) / 30 g in 1 TUBE |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | GEL;TOPICAL | Strength | 5% | ||||
Approval Date: | Jul 7, 2005 | TE: | AB | RLD: | Yes |
Expired US Patents for NDA 021794
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Abbvie | ACZONE | dapsone | GEL;TOPICAL | 021794-001 | Jul 7, 2005 | ⤷ Sign Up | ⤷ Sign Up |
Abbvie | ACZONE | dapsone | GEL;TOPICAL | 021794-001 | Jul 7, 2005 | ⤷ Sign Up | ⤷ Sign Up |
Abbvie | ACZONE | dapsone | GEL;TOPICAL | 021794-001 | Jul 7, 2005 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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