Details for New Drug Application (NDA): 087204
✉ Email this page to a colleague
NDA 087204 describes CROTAN, which is a drug marketed by Legacy Pharma and is included in one NDA. It is available from two suppliers. Additional details are available on the CROTAN profile page.
The generic ingredient in CROTAN is crotamiton. There are six drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the crotamiton profile page.
The generic ingredient in CROTAN is crotamiton. There are six drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the crotamiton profile page.
Summary for 087204
| Tradename: | CROTAN |
| Applicant: | Legacy Pharma |
| Ingredient: | crotamiton |
| Patents: | 0 |
Suppliers and Packaging for NDA: 087204
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| CROTAN | crotamiton | LOTION;TOPICAL | 087204 | ANDA | Marnel Pharmaceuticals, Inc. | 0682-0051 | 0682-0051-10 | 237 g in 1 BOTTLE, PLASTIC (0682-0051-10) |
| CROTAN | crotamiton | LOTION;TOPICAL | 087204 | ANDA | Marnel Pharmaceuticals, Inc. | 0682-0051 | 0682-0051-20 | 60 g in 1 BOTTLE, PLASTIC (0682-0051-20) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | LOTION;TOPICAL | Strength | 10% | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | AT | RLD: | No | ||||
Complete Access Available with Subscription
