Details for New Drug Application (NDA): 062286
NDA 062286 describes DICLOXACILLIN SODIUM, which is a drug marketed by Aurobindo Pharma, Chartwell Rx, and Apothecon, and is included in four NDAs. It is available from six suppliers. Additional details are available on the DICLOXACILLIN SODIUM profile page.
The generic ingredient in DICLOXACILLIN SODIUM is dicloxacillin sodium. There is one drug master file entry for this compound. Six 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 is one drug master file entry for this compound. Six suppliers are listed for this compound. Additional details are available on the dicloxacillin sodium profile page.
Summary for 062286
| Tradename: | DICLOXACILLIN SODIUM |
| Applicant: | Chartwell Rx |
| Ingredient: | dicloxacillin sodium |
| Patents: | 0 |
Suppliers and Packaging for NDA: 062286
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| DICLOXACILLIN SODIUM | dicloxacillin sodium | CAPSULE;ORAL | 062286 | ANDA | Teva Pharmaceuticals USA, Inc. | 0093-3123 | 0093-3123-01 | 100 CAPSULE in 1 BOTTLE (0093-3123-01) |
| DICLOXACILLIN SODIUM | dicloxacillin sodium | CAPSULE;ORAL | 062286 | ANDA | Teva Pharmaceuticals USA, Inc. | 0093-3125 | 0093-3125-01 | 100 CAPSULE in 1 BOTTLE (0093-3125-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | EQ 250MG BASE | ||||
| Approval Date: | Jun 3, 1982 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | EQ 500MG BASE | ||||
| Approval Date: | Jun 3, 1982 | TE: | AB | RLD: | No | ||||
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