Details for New Drug Application (NDA): 212025
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NDA 212025 describes APOMORPHINE HYDROCHLORIDE, which is a drug marketed by Trupharma and is included in one NDA. It is available from one supplier. Additional details are available on the APOMORPHINE HYDROCHLORIDE profile page.
The generic ingredient in APOMORPHINE HYDROCHLORIDE 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 APOMORPHINE HYDROCHLORIDE 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 212025
| Tradename: | APOMORPHINE HYDROCHLORIDE |
| Applicant: | Trupharma |
| Ingredient: | apomorphine hydrochloride |
| Patents: | 0 |
Pharmacology for NDA: 212025
| Mechanism of Action | Dopamine Agonists |
Medical Subject Heading (MeSH) Categories for 212025
Suppliers and Packaging for NDA: 212025
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| APOMORPHINE HYDROCHLORIDE | apomorphine hydrochloride | INJECTABLE;SUBCUTANEOUS | 212025 | ANDA | TruPharma, LLC | 52817-720 | 52817-720-05 | 5 CARTRIDGE in 1 CARTON (52817-720-05) / 3 mL in 1 CARTRIDGE (52817-720-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;SUBCUTANEOUS | Strength | 30MG/3ML (10MG/ML) | ||||
| Approval Date: | Feb 23, 2022 | TE: | AP | RLD: | No | ||||
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