Details for New Drug Application (NDA): 020452
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The generic ingredient in PARAPLATIN is carboplatin. There are eighteen drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the carboplatin profile page.
Summary for 020452
Tradename: | PARAPLATIN |
Applicant: | Cordenpharma |
Ingredient: | carboplatin |
Patents: | 0 |
Medical Subject Heading (MeSH) Categories for 020452
Profile for product number 001
Active Rx/OTC/Discontinued: | DISCN | Dosage: | INJECTABLE;INTRAVENOUS | Strength | 50MG/5ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
Approval Date: | Jul 14, 2003 | TE: | RLD: | Yes |
Profile for product number 002
Active Rx/OTC/Discontinued: | DISCN | Dosage: | INJECTABLE;INTRAVENOUS | Strength | 150MG/15ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
Approval Date: | Jul 14, 2003 | TE: | RLD: | Yes |
Profile for product number 003
Active Rx/OTC/Discontinued: | DISCN | Dosage: | INJECTABLE;INTRAVENOUS | Strength | 450MG/45ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
Approval Date: | Jul 14, 2003 | TE: | RLD: | Yes |
Expired US Patents for NDA 020452
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Cordenpharma | PARAPLATIN | carboplatin | INJECTABLE;INTRAVENOUS | 020452-004 | Jan 15, 2004 | ⤷ Sign Up | ⤷ Sign Up |
Cordenpharma | PARAPLATIN | carboplatin | INJECTABLE;INTRAVENOUS | 020452-001 | Jul 14, 2003 | ⤷ Sign Up | ⤷ Sign Up |
Cordenpharma | PARAPLATIN | carboplatin | INJECTABLE;INTRAVENOUS | 020452-003 | Jul 14, 2003 | ⤷ Sign Up | ⤷ Sign Up |
Cordenpharma | PARAPLATIN | carboplatin | INJECTABLE;INTRAVENOUS | 020452-002 | Jul 14, 2003 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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