Details for New Drug Application (NDA): 050557
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NDA 050557 describes BENZAMYCIN, which is a drug marketed by Valeant Intl and is included in one NDA. It is available from two suppliers. Additional details are available on the BENZAMYCIN profile page.
The generic ingredient in BENZAMYCIN is benzoyl peroxide; erythromycin. There are seventeen drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the benzoyl peroxide; erythromycin profile page.
The generic ingredient in BENZAMYCIN is benzoyl peroxide; erythromycin. There are seventeen drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the benzoyl peroxide; erythromycin profile page.
Summary for 050557
| Tradename: | BENZAMYCIN |
| Applicant: | Valeant Intl |
| Ingredient: | benzoyl peroxide; erythromycin |
| Patents: | 0 |
Suppliers and Packaging for NDA: 050557
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| BENZAMYCIN | benzoyl peroxide; erythromycin | GEL;TOPICAL | 050557 | NDA | Bausch Health US, LLC | 0187-5205 | 0187-5205-46 | 1 KIT in 1 BOX (0187-5205-46) * 1.6 g in 1 VIAL, PLASTIC * 40 g in 1 JAR |
| BENZAMYCIN | benzoyl peroxide; erythromycin | GEL;TOPICAL | 050557 | NDA AUTHORIZED GENERIC | Oceanside Pharmaceuticals | 68682-900 | 68682-900-23 | 1 KIT in 1 CARTON (68682-900-23) * .8 g in 1 VIAL, PLASTIC (68682-924-08) * 20 g in 1 JAR (68682-923-23) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | GEL;TOPICAL | Strength | 5%;3% | ||||
| Approval Date: | Oct 26, 1984 | TE: | AB | RLD: | Yes | ||||
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