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USFDA APPLICATION NUMBER - 20571 / DOSAGE - INJECTABLE;INJECTION - 100MG/5ML (20MG/ML)
| Active Ingredient/Active Moiety | ||
| Ingredient Name | Basis of Strength | Strength |
|---|---|---|
| IRINOTECAN HYDROCHLORIDE(UNII: 042LAQ1IIS) (IRINOTECAN - UNII:7673326042) | IRINOTECAN HYDROCHLORIDE | 20mg in 1 |
Inactive Ingredients
| Ingredient Name | Actavis Pharma, Inc. | Armas Pharmaceuticals Inc. | Fresenius Kabi USA, LLC | Heritage Pharmaceuticals Inc. | Pharmacia and Upjohn Company LLC | Sagent Pharmaceuticals | Sandoz Inc | Sun Pharma Global FZE | Teva Parenteral Medicines, Inc. | Areva Pharmaceuticals,Inc. | Cipla Limited | NorthStar RxLLC | BluePoint Laboratories |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| HYDROCHLORIC ACID(QTT17582CB) | |||||||||||||
| LACTIC ACID(33X04XA5AT) | |||||||||||||
| LACTIC ACID, UNSPECIFIED FORM(33X04XA5AT) | |||||||||||||
| sodium hydroxide(55X04QC32I) | |||||||||||||
| SORBITOL(506T60A25R) | |||||||||||||
| WATER(059QF0KO0R) |
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