Details for New Drug Application (NDA): 021264
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NDA 021264 describes APOKYN, 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 APOKYN profile page.
The generic ingredient in APOKYN is apomorphine hydrochloride. There are six drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the apomorphine hydrochloride profile page.
The generic ingredient in APOKYN is apomorphine hydrochloride. There are six drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the apomorphine hydrochloride profile page.
Summary for 021264
| Tradename: | APOKYN |
| Applicant: | Mdd Us |
| Ingredient: | apomorphine hydrochloride |
| Patents: | 0 |
Pharmacology for NDA: 021264
| Mechanism of Action | Dopamine Agonists |
Medical Subject Heading (MeSH) Categories for 021264
Suppliers and Packaging for NDA: 021264
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| APOKYN | apomorphine hydrochloride | INJECTABLE;SUBCUTANEOUS | 021264 | NDA | MDD US Operations, LLC | 27505-004 | 27505-004-05 | 5 CARTRIDGE in 1 CARTON (27505-004-05) / 3 mL in 1 CARTRIDGE (27505-004-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | INJECTABLE;SUBCUTANEOUS | Strength | 20MG/2ML (10MG/ML) | ||||
| Approval Date: | Apr 20, 2004 | TE: | RLD: | No | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;SUBCUTANEOUS | Strength | 30MG/3ML (10MG/ML) | ||||
| Approval Date: | Apr 20, 2004 | TE: | AP | RLD: | Yes | ||||
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