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Details for New Drug Application (NDA): 075710

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NDA 075710 describes ALENDRONATE SODIUM, which is a drug marketed by Dr Reddys Labs Ltd, Impax Labs Inc, Roxane, Sun Pharma Global, Aurobindo Pharma, Mylan, Jubilant Cadista, Austarpharma Llc, Cipla Ltd, Upsher-smith Labs, Apotex, Teva Pharms, and Watson Labs, and is included in fifteen NDAs. It is available from twenty-nine suppliers. Additional details are available on the ALENDRONATE SODIUM profile page.

The generic ingredient in ALENDRONATE SODIUM is alendronate sodium. There are twenty-five drug master file entries for this compound. Thirty-one suppliers are listed for this compound. Additional details are available on the alendronate sodium profile page.

Summary for NDA: 075710

Tradename:
ALENDRONATE SODIUM
Applicant:
Impax Labs Inc
Ingredient:
alendronate sodium
Patents:0
Therapeutic Class:Metabolic Bone Disease Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 075710

Ingredient-typeDiphosphonates

Suppliers and Packaging for NDA: 075710

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ALENDRONATE SODIUM
alendronate sodium
TABLET;ORAL 075710 ANDA Teva Pharmaceuticals USA Inc 0093-5140 0093-5140-01 100 TABLET in 1 BOTTLE (0093-5140-01)
ALENDRONATE SODIUM
alendronate sodium
TABLET;ORAL 075710 ANDA Teva Pharmaceuticals USA Inc 0093-5140 0093-5140-56 30 TABLET in 1 BOTTLE (0093-5140-56)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 5MG BASE
Approval Date:Feb 6, 2008TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 10MG BASE
Approval Date:Feb 6, 2008TE:ABRLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 35MG BASE
Approval Date:Feb 6, 2008TE:ABRLD:No


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