Details for New Drug Application (NDA): 207354
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The generic ingredient in LINEZOLID is linezolid. There are twenty-two drug master file entries for this compound. Twenty-four suppliers are listed for this compound. Additional details are available on the linezolid profile page.
Summary for 207354
Tradename: | LINEZOLID |
Applicant: | Nang Kuang Pharm Co |
Ingredient: | linezolid |
Patents: | 0 |
Suppliers and Packaging for NDA: 207354
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
LINEZOLID | linezolid | SOLUTION;INTRAVENOUS | 207354 | ANDA | Sun Pharmaceutical Industries, Inc. | 57664-682 | 57664-682-30 | 100 mL in 1 BAG (57664-682-30) |
LINEZOLID | linezolid | SOLUTION;INTRAVENOUS | 207354 | ANDA | Sun Pharmaceutical Industries, Inc. | 57664-683 | 57664-683-57 | 10 BAG in 1 BOX (57664-683-57) / 300 mL in 1 BAG (57664-683-31) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INTRAVENOUS | Strength | 200MG/100ML (2MG/ML) | ||||
Approval Date: | Dec 20, 2016 | TE: | AP | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INTRAVENOUS | Strength | 600MG/300ML (2MG/ML) | ||||
Approval Date: | Dec 20, 2016 | TE: | AP | RLD: | No |
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