Details for New Drug Application (NDA): 216845
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NDA 216845 describes DICLOXACILLIN SODIUM, which is a drug marketed by Aurobindo Pharma, Sandoz, Teva, and Apothecon, and is included in four NDAs. It is available from seven suppliers. Additional details are available on the DICLOXACILLIN SODIUM profile page.
The generic ingredient in DICLOXACILLIN SODIUM is dicloxacillin sodium. There are nine drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the dicloxacillin sodium profile page.
The generic ingredient in DICLOXACILLIN SODIUM is dicloxacillin sodium. There are nine drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the dicloxacillin sodium profile page.
Summary for 216845
| Tradename: | DICLOXACILLIN SODIUM |
| Applicant: | Aurobindo Pharma |
| Ingredient: | dicloxacillin sodium |
| Patents: | 0 |
| Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 216845
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| DICLOXACILLIN SODIUM | dicloxacillin sodium | CAPSULE;ORAL | 216845 | ANDA | Aurobindo Pharma Limited | 59651-565 | 59651-565-01 | 100 CAPSULE in 1 BOTTLE (59651-565-01) |
| DICLOXACILLIN SODIUM | dicloxacillin sodium | CAPSULE;ORAL | 216845 | ANDA | Aurobindo Pharma Limited | 59651-566 | 59651-566-01 | 100 CAPSULE in 1 BOTTLE (59651-566-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | EQ 250MG BASE | ||||
| Approval Date: | Sep 23, 2022 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | EQ 500MG BASE | ||||
| Approval Date: | Sep 23, 2022 | TE: | AB | RLD: | No | ||||
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