Details for New Drug Application (NDA): 204902
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NDA 204902 describes DAPIPRAZOLE HYDROCHLORIDE, which is a drug marketed by Baradaina Llc and Fera Pharms and is included in two NDAs. It is available from one supplier. Additional details are available on the DAPIPRAZOLE HYDROCHLORIDE profile page.
The generic ingredient in DAPIPRAZOLE HYDROCHLORIDE is dapiprazole hydrochloride. There are two drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the dapiprazole hydrochloride profile page.
The generic ingredient in DAPIPRAZOLE HYDROCHLORIDE is dapiprazole hydrochloride. There are two drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the dapiprazole hydrochloride profile page.
Summary for 204902
| Tradename: | DAPIPRAZOLE HYDROCHLORIDE |
| Applicant: | Baradaina Llc |
| Ingredient: | dapiprazole hydrochloride |
| Patents: | 0 |
Suppliers and Packaging for NDA: 204902
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| DAPIPRAZOLE HYDROCHLORIDE | dapiprazole hydrochloride | SOLUTION/DROPS;OPHTHALMIC | 204902 | ANDA | Baradaina, LLC | 53020-265 | 53020-265-01 | 1 KIT in 1 CARTON (53020-265-01) * 5 mL in 1 VIAL (53020-255-01) * 5 mL in 1 VIAL (53020-245-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | SOLUTION/DROPS;OPHTHALMIC | Strength | 0.5% | ||||
| Approval Date: | May 30, 2019 | TE: | RLD: | No | |||||
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