Details for New Drug Application (NDA): 203999
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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 203999
Tradename: | DACTINOMYCIN |
Applicant: | Xgen Pharms |
Ingredient: | dactinomycin |
Patents: | 0 |
Pharmacology for NDA: 203999
Mechanism of Action | Nucleic Acid Synthesis Inhibitors Protein Synthesis Inhibitors |
Medical Subject Heading (MeSH) Categories for 203999
Suppliers and Packaging for NDA: 203999
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
DACTINOMYCIN | dactinomycin | INJECTABLE;INJECTION | 203999 | ANDA | XGen Pharmaceuticals DJB, Inc. | 39822-2100 | 39822-2100-2 | 1 VIAL, SINGLE-DOSE in 1 CARTON (39822-2100-2) / 1 mL in 1 VIAL, SINGLE-DOSE (39822-2100-1) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 0.5MG/VIAL | ||||
Approval Date: | May 20, 2019 | TE: | AP | RLD: | No |
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