Details for New Drug Application (NDA): 019853
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NDA 019853 describes CUPRIMINE, which is a drug marketed by Valeant Pharms Intl and is included in one NDA. It is available from two suppliers. Additional details are available on the CUPRIMINE profile page.
The generic ingredient in CUPRIMINE is penicillamine. There are eighteen drug master file entries for this compound. Fourteen suppliers are listed for this compound. Additional details are available on the penicillamine profile page.
The generic ingredient in CUPRIMINE is penicillamine. There are eighteen drug master file entries for this compound. Fourteen suppliers are listed for this compound. Additional details are available on the penicillamine profile page.
Summary for 019853
| Tradename: | CUPRIMINE |
| Applicant: | Valeant Pharms Intl |
| Ingredient: | penicillamine |
| Patents: | 0 |
| Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 019853
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| CUPRIMINE | penicillamine | CAPSULE;ORAL | 019853 | NDA | Bausch Health US, LLC | 25010-705 | 25010-705-15 | 100 CAPSULE in 1 BOTTLE (25010-705-15) |
| CUPRIMINE | penicillamine | CAPSULE;ORAL | 019853 | NDA AUTHORIZED GENERIC | Oceanside Pharmaceuticals | 68682-020 | 68682-020-10 | 100 CAPSULE in 1 BOTTLE (68682-020-10) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 250MG | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | AB | RLD: | Yes | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | CAPSULE;ORAL | Strength | 125MG | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | RLD: | No | |||||
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