Details for New Drug Application (NDA): 214056
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NDA 214056 describes ONAPGO, which is a drug marketed by Mdd Us and is included in one NDA. It is available from one supplier. Additional details are available on the ONAPGO profile page.
The generic ingredient in ONAPGO is apomorphine hydrochloride. There are six drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the apomorphine hydrochloride profile page.
The generic ingredient in ONAPGO is apomorphine hydrochloride. There are six drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the apomorphine hydrochloride profile page.
Summary for 214056
| Tradename: | ONAPGO |
| Applicant: | Mdd Us |
| Ingredient: | apomorphine hydrochloride |
| Patents: | 0 |
Pharmacology for NDA: 214056
| Mechanism of Action | Dopamine Agonists |
Medical Subject Heading (MeSH) Categories for 214056
Suppliers and Packaging for NDA: 214056
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ONAPGO | apomorphine hydrochloride | SOLUTION;SUBCUTANEOUS | 214056 | NDA | MDD US Operations, LLC, a subsidiary of Supernus Pharmaceuticals, Inc | 27505-006 | 27505-006-05 | 5 CARTRIDGE in 1 CARTON (27505-006-05) / 20 mL in 1 CARTRIDGE (27505-006-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;SUBCUTANEOUS | Strength | 98MG/20ML (4.9MG/ML) | ||||
| Approval Date: | Feb 3, 2025 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Feb 3, 2028 | ||||||||
| Regulatory Exclusivity Use: | NEW PRODUCT | ||||||||
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