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Details for New Drug Application (NDA): 019545

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NDA 019545 describes DIDRONEL, which is a drug marketed by Apil and Mgi Pharma Inc and is included in two NDAs. Additional details are available on the DIDRONEL profile page.

The generic ingredient in DIDRONEL is etidronate disodium. There are four drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the etidronate disodium profile page.

Summary for NDA: 019545

Mgi Pharma Inc
etidronate disodium
Therapeutic Class:Metabolic Bone Disease Agents

Summary for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrength50MG/ML
Approval Date:Apr 20, 1987TE:RLD:No

Expired Orange Book Patents for NDA: 019545

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Mgi Pharma Inc
etidronate disodium
INJECTABLE;INJECTION019545-001Apr 20, 19873,683,080<disabled>
Mgi Pharma Inc
etidronate disodium
INJECTABLE;INJECTION019545-001Apr 20, 19874,216,211<disabled>
Mgi Pharma Inc
etidronate disodium
INJECTABLE;INJECTION019545-001Apr 20, 19874,254,114<disabled>
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