Details for New Drug Application (NDA): 087204
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NDA 087204 describes CROTAN, which is a drug marketed by Legacy Pharma and is included in one NDA. It is available from one supplier. 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. One supplier is 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. One supplier is 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 |
| Formulation / Manufacturing: | see details |
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 | ||||
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