Details for New Drug Application (NDA): 200480
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NDA 200480 describes DYCLOPRO, which is a drug marketed by Septodont and is included in one NDA. It is available from one supplier. Additional details are available on the DYCLOPRO profile page.
The generic ingredient in DYCLOPRO is dyclonine hydrochloride. There are four drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the dyclonine hydrochloride profile page.
The generic ingredient in DYCLOPRO is dyclonine hydrochloride. There are four drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the dyclonine hydrochloride profile page.
Summary for 200480
| Tradename: | DYCLOPRO |
| Applicant: | Septodont |
| Ingredient: | dyclonine hydrochloride |
| Patents: | 0 |
| Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 200480
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| DYCLOPRO | dyclonine hydrochloride | SOLUTION;TOPICAL | 200480 | ANDA | Septodont Inc | 0362-3971 | 0362-3971-05 | 1 BOTTLE in 1 BOTTLE (0362-3971-05) / 30 mL in 1 BOTTLE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;TOPICAL | Strength | 0.5% | ||||
| Approval Date: | Nov 20, 2018 | TE: | RLD: | No | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;TOPICAL | Strength | 1% | ||||
| Approval Date: | Nov 20, 2018 | TE: | RLD: | No | |||||
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