Details for New Drug Application (NDA): 215000
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The generic ingredient in CARMUSTINE is carmustine. There are eleven drug master file entries for this compound. Fourteen suppliers are listed for this compound. Additional details are available on the carmustine profile page.
Summary for 215000
Tradename: | CARMUSTINE |
Applicant: | Accord Hlthcare |
Ingredient: | carmustine |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Medical Subject Heading (MeSH) Categories for 215000
Suppliers and Packaging for NDA: 215000
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
CARMUSTINE | carmustine | POWDER;INTRAVENOUS | 215000 | NDA | Accord Healthcare Inc. | 16729-545 | 16729-545-63 | 1 KIT in 1 CARTON (16729-545-63) * 3 mL in 1 VIAL (16729-544-85) * 20 mL in 1 VIAL, SINGLE-DOSE (16729-543-05) |
CARMUSTINE | carmustine | POWDER;INTRAVENOUS | 215000 | NDA | Accord Healthcare Inc. | 16729-548 | 16729-548-63 | 1 KIT in 1 CARTON (16729-548-63) * 9 mL in 1 VIAL (16729-547-19) * 100 mL in 1 VIAL, SINGLE-DOSE (16729-546-01) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | POWDER;INTRAVENOUS | Strength | 50MG/VIAL | ||||
Approval Date: | May 16, 2022 | TE: | RLD: | Yes |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | POWDER;INTRAVENOUS | Strength | 300MG/VIAL | ||||
Approval Date: | May 16, 2022 | TE: | RLD: | Yes |
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