Details for New Drug Application (NDA): 207232
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The generic ingredient in DACTINOMYCIN is dactinomycin. There are three drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the dactinomycin profile page.
Summary for 207232
Tradename: | DACTINOMYCIN |
Applicant: | Hisun Pharm Hangzhou |
Ingredient: | dactinomycin |
Patents: | 0 |
Pharmacology for NDA: 207232
Mechanism of Action | Nucleic Acid Synthesis Inhibitors Protein Synthesis Inhibitors |
Medical Subject Heading (MeSH) Categories for 207232
Suppliers and Packaging for NDA: 207232
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
DACTINOMYCIN | dactinomycin | INJECTABLE;INJECTION | 207232 | ANDA | Hisun Pharmaceuticals USA, Inc. | 42658-008 | 42658-008-01 | 1 VIAL in 1 CARTON (42658-008-01) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 0.5MG/VIAL | ||||
Approval Date: | Jul 16, 2019 | TE: | AP | RLD: | No |
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