Details for New Drug Application (NDA): 090453
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NDA 090453 describes MOLINDONE HYDROCHLORIDE, which is a drug marketed by Epic Pharma Llc and is included in one NDA. It is available from one supplier. Additional details are available on the MOLINDONE HYDROCHLORIDE profile page.
The generic ingredient in MOLINDONE HYDROCHLORIDE is molindone hydrochloride. There are four drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the molindone hydrochloride profile page.
The generic ingredient in MOLINDONE HYDROCHLORIDE is molindone hydrochloride. There are four drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the molindone hydrochloride profile page.
Summary for 090453
| Tradename: | MOLINDONE HYDROCHLORIDE |
| Applicant: | Epic Pharma Llc |
| Ingredient: | molindone hydrochloride |
| Patents: | 0 |
| Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 090453
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| MOLINDONE HYDROCHLORIDE | molindone hydrochloride | TABLET;ORAL | 090453 | ANDA | EPIC PHARMA, LLC | 42806-336 | 42806-336-01 | 100 TABLET in 1 BOTTLE (42806-336-01) |
| MOLINDONE HYDROCHLORIDE | molindone hydrochloride | TABLET;ORAL | 090453 | ANDA | EPIC PHARMA, LLC | 42806-337 | 42806-337-01 | 100 TABLET in 1 BOTTLE (42806-337-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 5MG | ||||
| Approval Date: | Mar 20, 2015 | TE: | RLD: | No | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 10MG | ||||
| Approval Date: | Mar 20, 2015 | TE: | RLD: | No | |||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 25MG | ||||
| Approval Date: | Mar 20, 2015 | TE: | RLD: | No | |||||
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