Details for New Drug Application (NDA): 065385
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NDA 065385 describes ERYTHROMYCIN AND BENZOYL PEROXIDE, which is a drug marketed by Encube and Rising and is included in two NDAs. It is available from one supplier. Additional details are available on the ERYTHROMYCIN AND BENZOYL PEROXIDE profile page.
The generic ingredient in ERYTHROMYCIN AND BENZOYL PEROXIDE 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 ERYTHROMYCIN AND BENZOYL PEROXIDE 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 065385
| Tradename: | ERYTHROMYCIN AND BENZOYL PEROXIDE |
| Applicant: | Rising |
| Ingredient: | benzoyl peroxide; erythromycin |
| Patents: | 0 |
Pharmacology for NDA: 065385
| Physiological Effect | Decreased Sebaceous Gland Activity |
Suppliers and Packaging for NDA: 065385
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ERYTHROMYCIN AND BENZOYL PEROXIDE | benzoyl peroxide; erythromycin | GEL;TOPICAL | 065385 | ANDA | Rising Pharma Holdings, Inc. | 64980-328 | 64980-328-01 | 23.3 g in 1 JAR (64980-328-01) |
| ERYTHROMYCIN AND BENZOYL PEROXIDE | benzoyl peroxide; erythromycin | GEL;TOPICAL | 065385 | ANDA | Rising Pharma Holdings, Inc. | 64980-328 | 64980-328-02 | 46.6 g in 1 JAR (64980-328-02) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | GEL;TOPICAL | Strength | 5%;3% | ||||
| Approval Date: | Sep 18, 2015 | TE: | AB | RLD: | No | ||||
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