Details for New Drug Application (NDA): 211813
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The generic ingredient in LINEZOLID is linezolid. There are twenty-two drug master file entries for this compound. Twenty-five suppliers are listed for this compound. Additional details are available on the linezolid profile page.
Summary for 211813
Tradename: | LINEZOLID |
Applicant: | Hetero Labs |
Ingredient: | linezolid |
Patents: | 0 |
Suppliers and Packaging for NDA: 211813
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
LINEZOLID | linezolid | FOR SUSPENSION;ORAL | 211813 | ANDA | Camber Pharmaceuticals, Inc. | 31722-865 | 31722-865-25 | 1 BOTTLE, GLASS in 1 CARTON (31722-865-25) / 150 mL in 1 BOTTLE, GLASS |
LINEZOLID | linezolid | FOR SUSPENSION;ORAL | 211813 | ANDA | American Health Packaging | 60687-754 | 60687-754-05 | 1 BOTTLE, GLASS in 1 CARTON (60687-754-05) / 150 mL in 1 BOTTLE, GLASS |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | FOR SUSPENSION;ORAL | Strength | 100MG/5ML | ||||
Approval Date: | Oct 31, 2022 | TE: | AB | RLD: | No |
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