Details for New Drug Application (NDA): 065042
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NDA 065042 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 065042
| Tradename: | BLEOMYCIN SULFATE |
| Applicant: | Hikma |
| Ingredient: | bleomycin sulfate |
| Patents: | 0 |
Suppliers and Packaging for NDA: 065042
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| BLEOMYCIN SULFATE | bleomycin sulfate | INJECTABLE;INJECTION | 065042 | ANDA | Hikma Pharmaceuticals USA Inc. | 0143-9240 | 0143-9240-01 | 1 VIAL in 1 BOX, UNIT-DOSE (0143-9240-01) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL |
| BLEOMYCIN SULFATE | bleomycin sulfate | INJECTABLE;INJECTION | 065042 | ANDA | Hikma Pharmaceuticals USA Inc. | 0143-9241 | 0143-9241-01 | 1 VIAL in 1 BOX, UNIT-DOSE (0143-9241-01) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | EQ 30 UNITS BASE/VIAL | ||||
| Approval Date: | Oct 17, 2001 | TE: | AP | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | EQ 15 UNITS BASE/VIAL | ||||
| Approval Date: | Oct 17, 2001 | TE: | AP | RLD: | No | ||||
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