Details for New Drug Application (NDA): 019931
✉ Email this page to a colleague
NDA 019931 describes KLARON, which is a drug marketed by Bausch and is included in one NDA. It is available from two suppliers. Additional details are available on the KLARON profile page.
The generic ingredient in KLARON is sulfacetamide sodium. There are three drug master file entries for this compound. Thirteen suppliers are listed for this compound. Additional details are available on the sulfacetamide sodium profile page.
The generic ingredient in KLARON is sulfacetamide sodium. There are three drug master file entries for this compound. Thirteen suppliers are listed for this compound. Additional details are available on the sulfacetamide sodium profile page.
Summary for 019931
| Tradename: | KLARON |
| Applicant: | Bausch |
| Ingredient: | sulfacetamide sodium |
| Patents: | 0 |
Suppliers and Packaging for NDA: 019931
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| KLARON | sulfacetamide sodium | LOTION;TOPICAL | 019931 | NDA | Bausch Health US, LLC | 0187-5198 | 0187-5198-04 | 1 BOTTLE, PLASTIC in 1 CARTON (0187-5198-04) / 118 mL in 1 BOTTLE, PLASTIC |
| KLARON | sulfacetamide sodium | LOTION;TOPICAL | 019931 | NDA AUTHORIZED GENERIC | Oceanside Pharmaceuticals | 68682-010 | 68682-010-04 | 1 BOTTLE, PLASTIC in 1 CARTON (68682-010-04) / 118 mL in 1 BOTTLE, PLASTIC |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | LOTION;TOPICAL | Strength | 10% | ||||
| Approval Date: | Dec 23, 1996 | TE: | AB | RLD: | Yes | ||||
Complete Access Available with Subscription
