Details for New Drug Application (NDA): 019297
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NDA 019297 describes NOVANTRONE, which is a drug marketed by Emd Serono and is included in one NDA. Additional details are available on the NOVANTRONE profile page.
The generic ingredient in NOVANTRONE is mitoxantrone hydrochloride. There are seven drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the mitoxantrone hydrochloride profile page.
The generic ingredient in NOVANTRONE is mitoxantrone hydrochloride. There are seven drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the mitoxantrone hydrochloride profile page.
Summary for 019297
| Tradename: | NOVANTRONE |
| Applicant: | Emd Serono |
| Ingredient: | mitoxantrone hydrochloride |
| Patents: | 0 |
Medical Subject Heading (MeSH) Categories for 019297
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | INJECTABLE;INJECTION | Strength | EQ 20MG BASE/10ML (EQ 2MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
| Approval Date: | Dec 23, 1987 | TE: | RLD: | Yes | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | INJECTABLE;INJECTION | Strength | EQ 25MG BASE/12.5ML (EQ 2MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
| Approval Date: | Dec 23, 1987 | TE: | RLD: | Yes | |||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | INJECTABLE;INJECTION | Strength | EQ 30MG BASE/15ML (EQ 2MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
| Approval Date: | Dec 23, 1987 | TE: | RLD: | Yes | |||||
Expired US Patents for NDA 019297
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Emd Serono | NOVANTRONE | mitoxantrone hydrochloride | INJECTABLE;INJECTION | 019297-001 | Dec 23, 1987 | ⤷ Subscribe | ⤷ Subscribe |
| Emd Serono | NOVANTRONE | mitoxantrone hydrochloride | INJECTABLE;INJECTION | 019297-001 | Dec 23, 1987 | ⤷ Subscribe | ⤷ Subscribe |
| Emd Serono | NOVANTRONE | mitoxantrone hydrochloride | INJECTABLE;INJECTION | 019297-003 | Dec 23, 1987 | ⤷ Subscribe | ⤷ Subscribe |
| Emd Serono | NOVANTRONE | mitoxantrone hydrochloride | INJECTABLE;INJECTION | 019297-002 | Dec 23, 1987 | ⤷ Subscribe | ⤷ Subscribe |
| Emd Serono | NOVANTRONE | mitoxantrone hydrochloride | INJECTABLE;INJECTION | 019297-001 | Dec 23, 1987 | ⤷ Subscribe | ⤷ Subscribe |
| Emd Serono | NOVANTRONE | mitoxantrone hydrochloride | INJECTABLE;INJECTION | 019297-001 | Dec 23, 1987 | ⤷ Subscribe | ⤷ Subscribe |
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