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Details for New Drug Application (NDA): 211553
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The generic ingredient in CALCIUM CHLORIDE 10% is calcium chloride. There are two hundred and eighty-two drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the calcium chloride profile page.
Summary for 211553
Tradename: | CALCIUM CHLORIDE 10% |
Applicant: | Medefil Inc |
Ingredient: | calcium chloride |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 211553
Physiological Effect | Increased Coagulation Factor Activity |
Suppliers and Packaging for NDA: 211553
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
CALCIUM CHLORIDE 10% | calcium chloride | INJECTABLE;INJECTION | 211553 | ANDA | Medefil, Inc. | 64253-900 | 64253-900-36 | 60 SYRINGE, PLASTIC in 1 BOX (64253-900-36) > 10 mL in 1 SYRINGE, PLASTIC (64253-900-30) |
CALCIUM CHLORIDE 10% | calcium chloride | INJECTABLE;INJECTION | 211553 | ANDA | Medefil, Inc. | 64253-900 | 64253-900-91 | 10 SYRINGE, PLASTIC in 1 BOX (64253-900-91) > 10 mL in 1 SYRINGE, PLASTIC |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 100MG/ML | ||||
Approval Date: | May 1, 2019 | TE: | AP | RLD: | No |
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