Details for New Drug Application (NDA): 021197
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NDA 021197 describes CETROTIDE, which is a drug marketed by Emd Serono Inc and is included in one NDA. It is available from one supplier. Additional details are available on the CETROTIDE profile page.
The generic ingredient in CETROTIDE 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.
The generic ingredient in CETROTIDE 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 021197
| Tradename: | CETROTIDE |
| Applicant: | Emd Serono Inc |
| Ingredient: | cetrorelix acetate |
| Patents: | 0 |
Suppliers and Packaging for NDA: 021197
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| CETROTIDE | cetrorelix acetate | POWDER;SUBCUTANEOUS | 021197 | NDA | EMD Serono, Inc. | 44087-1225 | 44087-1225-1 | 1 KIT in 1 CARTON (44087-1225-1) * 1 mL in 1 VIAL, GLASS * 1 mL in 1 SYRINGE, GLASS |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | POWDER;SUBCUTANEOUS | Strength | EQ 0.25MG BASE/VIAL | ||||
| Approval Date: | Aug 11, 2000 | TE: | AP | RLD: | Yes | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | POWDER;SUBCUTANEOUS | Strength | EQ 3MG BASE/VIAL | ||||
| Approval Date: | Aug 11, 2000 | TE: | RLD: | Yes | |||||
Expired US Patents for NDA 021197
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