Details for New Drug Application (NDA): 065185
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NDA 065185 describes BLEOMYCIN SULFATE, which is a drug marketed by Cipla, Fresenius Kabi Usa, Hikma, Hospira, Meitheal, Pharmachemie Bv, Teva Parenteral, and Teva Pharms Usa, and is included in eight NDAs. It is available from six suppliers. Additional details are available on the BLEOMYCIN SULFATE profile page.
The generic ingredient in BLEOMYCIN SULFATE is bleomycin sulfate. There are six drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the bleomycin sulfate profile page.
The generic ingredient in BLEOMYCIN SULFATE is bleomycin sulfate. There are six drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the bleomycin sulfate profile page.
Summary for 065185
| Tradename: | BLEOMYCIN SULFATE |
| Applicant: | Fresenius Kabi Usa |
| Ingredient: | bleomycin sulfate |
| Patents: | 0 |
Suppliers and Packaging for NDA: 065185
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| BLEOMYCIN SULFATE | bleomycin sulfate | INJECTABLE;INJECTION | 065185 | ANDA | Fresenius Kabi USA, LLC | 63323-136 | 63323-136-10 | 1 VIAL in 1 CARTON (63323-136-10) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL |
| BLEOMYCIN SULFATE | bleomycin sulfate | INJECTABLE;INJECTION | 065185 | ANDA | Fresenius Kabi USA, LLC | 63323-137 | 63323-137-20 | 1 VIAL in 1 CARTON (63323-137-20) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | EQ 15 UNITS BASE/VIAL | ||||
| Approval Date: | Jan 28, 2008 | TE: | AP | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | EQ 30 UNITS BASE/VIAL | ||||
| Approval Date: | Jan 28, 2008 | TE: | AP | RLD: | No | ||||
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