Details for New Drug Application (NDA): 203661
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The generic ingredient in CEFAZOLIN SODIUM is cefazolin sodium. There are twenty-seven drug master file entries for this compound. Twenty-one suppliers are listed for this compound. Additional details are available on the cefazolin sodium profile page.
Summary for 203661
Tradename: | CEFAZOLIN SODIUM |
Applicant: | Qilu |
Ingredient: | cefazolin sodium |
Patents: | 0 |
Suppliers and Packaging for NDA: 203661
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
CEFAZOLIN SODIUM | cefazolin sodium | INJECTABLE;INJECTION | 203661 | ANDA | Henry Schein, Inc. | 0404-9833 | 0404-9833-99 | 1 VIAL, SINGLE-DOSE in 1 BAG (0404-9833-99) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-DOSE |
CEFAZOLIN SODIUM | cefazolin sodium | INJECTABLE;INJECTION | 203661 | ANDA | Apotex Corp. | 60505-6142 | 60505-6142-5 | 25 VIAL, SINGLE-DOSE in 1 CARTON (60505-6142-5) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (60505-6142-0) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | EQ 1GM BASE/VIAL | ||||
Approval Date: | Dec 28, 2015 | TE: | AP | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | EQ 2GM BASE/VIAL | ||||
Approval Date: | Mar 11, 2022 | TE: | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | EQ 3GM BASE/VIAL | ||||
Approval Date: | Jan 24, 2024 | TE: | RLD: | No |
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