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Details for New Drug Application (NDA): 075800

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NDA 075800 describes ETIDRONATE DISODIUM, which is a drug marketed by Mylan and is included in one NDA. It is available from two suppliers. Additional details are available on the ETIDRONATE DISODIUM profile page.

The generic ingredient in ETIDRONATE DISODIUM 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: 075800

Therapeutic Class:Metabolic Bone Disease Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 075800


Suppliers and Packaging for NDA: 075800

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
etidronate disodium
TABLET;ORAL 075800 ANDA Mylan Pharmaceuticals Inc. 0378-3286 0378-3286-91 60 TABLET in 1 BOTTLE, PLASTIC (0378-3286-91)
etidronate disodium
TABLET;ORAL 075800 ANDA Mylan Pharmaceuticals Inc. 0378-3288 0378-3288-91 60 TABLET in 1 BOTTLE, PLASTIC (0378-3288-91)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength200MG
Approval Date:Jan 24, 2003TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength400MG
Approval Date:Jan 24, 2003TE:ABRLD:No

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.