Details for New Drug Application (NDA): 019854
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NDA 019854 describes DEPEN, which is a drug marketed by Mylan Speciality Lp and is included in one NDA. It is available from one supplier. Additional details are available on the DEPEN profile page.
The generic ingredient in DEPEN is penicillamine. There are eighteen drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the penicillamine profile page.
The generic ingredient in DEPEN is penicillamine. There are eighteen drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the penicillamine profile page.
Summary for 019854
| Tradename: | DEPEN |
| Applicant: | Mylan Speciality Lp |
| Ingredient: | penicillamine |
| Patents: | 0 |
Suppliers and Packaging for NDA: 019854
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| DEPEN | penicillamine | TABLET;ORAL | 019854 | NDA | Viatris Specialty LLC | 0037-4401 | 0037-4401-01 | 100 TABLET in 1 BOTTLE (0037-4401-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 250MG | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | AB | RLD: | Yes | ||||
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