Details for New Drug Application (NDA): 215737
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The generic ingredient in CETRORELIX ACETATE is cetrorelix acetate. There is one drug master file entry for this compound. Seven suppliers are listed for this compound. Additional details are available on the cetrorelix acetate profile page.
Summary for 215737
Tradename: | CETRORELIX ACETATE |
Applicant: | Teva Pharms Inc |
Ingredient: | cetrorelix acetate |
Patents: | 0 |
Suppliers and Packaging for NDA: 215737
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
CETRORELIX ACETATE | cetrorelix acetate | POWDER;SUBCUTANEOUS | 215737 | ANDA | Teva Pharmaceuticals, Inc. | 0480-5795 | 0480-5795-08 | 1 TRAY in 1 CARTON (0480-5795-08) / 1 KIT in 1 TRAY * 1 mL in 1 VIAL, SINGLE-DOSE (0480-3583-01) * 1 mL in 1 SYRINGE (0480-3584-21) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | POWDER;SUBCUTANEOUS | Strength | EQ 0.25MG BASE/VIAL | ||||
Approval Date: | Aug 12, 2022 | TE: | AP | RLD: | No |
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