Details for New Drug Application (NDA): 020637
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The generic ingredient in GLIADEL is carmustine. There are eleven drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the carmustine profile page.
Summary for 020637
Tradename: | GLIADEL |
Applicant: | Azurity |
Ingredient: | carmustine |
Patents: | 0 |
Pharmacology for NDA: 020637
Mechanism of Action | Alkylating Activity |
Medical Subject Heading (MeSH) Categories for 020637
Suppliers and Packaging for NDA: 020637
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
GLIADEL | carmustine | IMPLANT;INTRACRANIAL | 020637 | NDA | Azurity Pharmaceuticals, Inc. | 24338-050 | 24338-050-08 | 8 POUCH in 1 BOX (24338-050-08) / 1 WAFER in 1 POUCH |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | IMPLANT;INTRACRANIAL | Strength | 7.7MG | ||||
Approval Date: | Sep 23, 1996 | TE: | RLD: | Yes |
Expired US Patents for NDA 020637
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Azurity | GLIADEL | carmustine | IMPLANT;INTRACRANIAL | 020637-001 | Sep 23, 1996 | 4,757,128 | ⤷ Subscribe |
Azurity | GLIADEL | carmustine | IMPLANT;INTRACRANIAL | 020637-001 | Sep 23, 1996 | 5,179,189 | ⤷ Subscribe |
Azurity | GLIADEL | carmustine | IMPLANT;INTRACRANIAL | 020637-001 | Sep 23, 1996 | 4,789,724 | ⤷ Subscribe |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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