Details for New Drug Application (NDA): 211229
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The generic ingredient in CARMUSTINE 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 211229
Tradename: | CARMUSTINE |
Applicant: | Amneal |
Ingredient: | carmustine |
Patents: | 0 |
Medical Subject Heading (MeSH) Categories for 211229
Suppliers and Packaging for NDA: 211229
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
CARMUSTINE | carmustine | INJECTABLE;INJECTION | 211229 | ANDA | Amneal Pharmaceuticals LLC | 70121-1482 | 70121-1482-2 | 1 KIT in 1 CARTON (70121-1482-2) * 3 mL in 1 VIAL (70121-3639-1) * 30 mL in 1 VIAL, SINGLE-DOSE (70121-1668-1) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 100MG/VIAL | ||||
Approval Date: | Oct 16, 2018 | TE: | AP | RLD: | No |
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