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Details for New Drug Application (NDA): 061454

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NDA 061454 describes DICLOXACILLIN SODIUM, which is a drug marketed by Sandoz, Apothecon, and Teva, and is included in three NDAs. It is available from fifteen 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. Fifteen suppliers are listed for this compound. Additional details are available on the dicloxacillin sodium profile page.

Summary for NDA: 061454

Tradename:
DICLOXACILLIN SODIUM
Applicant:
Sandoz
Ingredient:
dicloxacillin sodium
Patents:0
Therapeutic Class:Antibacterials
Formulation / Manufacturing:see details

Pharmacology for NDA: 061454

Ingredient-typePenicillins

Suppliers and Packaging for NDA: 061454

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DICLOXACILLIN SODIUM
dicloxacillin sodium
CAPSULE;ORAL 061454 ANDA Liberty Pharmaceuticals, Inc. 0440-1380 0440-1380-40 40 CAPSULE in 1 BOTTLE, PLASTIC (0440-1380-40)
DICLOXACILLIN SODIUM
dicloxacillin sodium
CAPSULE;ORAL 061454 ANDA Sandoz Inc 0781-2248 0781-2248-01 100 CAPSULE in 1 BOTTLE (0781-2248-01)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 250MG BASE
Approval Date:Approved Prior to Jan 1, 1982TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 125MG BASE
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 500MG BASE
Approval Date:Approved Prior to Jan 1, 1982TE:ABRLD:Yes


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