Details for New Drug Application (NDA): 206369
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The generic ingredient in STERILE WATER FOR INJECTION is sterile water for injection. There are one thousand and seventy-two drug master file entries for this compound. Twenty-one suppliers are listed for this compound. Additional details are available on the sterile water for injection profile page.
Summary for 206369
Tradename: | STERILE WATER FOR INJECTION |
Applicant: | Hikma |
Ingredient: | sterile water for injection |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 206369
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
STERILE WATER FOR INJECTION | sterile water for injection | LIQUID;N/A | 206369 | ANDA | Hikma Pharmaceuticals USA Inc. | 0641-6147 | 0641-6147-10 | 10 VIAL in 1 CARTON (0641-6147-10) / 10 mL in 1 VIAL (0641-6147-01) |
STERILE WATER FOR INJECTION | sterile water for injection | LIQUID;N/A | 206369 | ANDA | Hikma Pharmaceuticals USA Inc. | 0641-6147 | 0641-6147-25 | 25 VIAL in 1 CARTON (0641-6147-25) / 10 mL in 1 VIAL (0641-6147-01) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | LIQUID;N/A | Strength | 100% (10ML) | ||||
Approval Date: | Sep 2, 2015 | TE: | AP | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | DISCN | Dosage: | LIQUID;N/A | Strength | 100% (20ML) | ||||
Approval Date: | Sep 2, 2015 | TE: | RLD: | No |
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