Details for New Drug Application (NDA): 209921
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NDA 209921 describes LUXZYLA, which is a drug marketed by Ani Pharms and is included in one NDA. It is available from one supplier. Additional details are available on the LUXZYLA profile page.
The generic ingredient in LUXZYLA 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 LUXZYLA 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 209921
| Tradename: | LUXZYLA |
| Applicant: | Ani Pharms |
| Ingredient: | penicillamine |
| Patents: | 0 |
Suppliers and Packaging for NDA: 209921
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| LUXZYLA | penicillamine | CAPSULE;ORAL | 209921 | ANDA | ANI Pharmaceuticals, Inc. | 62559-970 | 62559-970-01 | 100 CAPSULE in 1 BOTTLE (62559-970-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | CAPSULE;ORAL | Strength | 250MG | ||||
| Approval Date: | May 7, 2019 | TE: | RLD: | No | |||||
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