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Details for New Drug Application (NDA): 077982

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NDA 077982 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, Sandoz, 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: 077982

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

Pharmacology for NDA: 077982


Suppliers and Packaging for NDA: 077982

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
alendronate sodium
TABLET;ORAL 077982 ANDA Apotex Corp. 60505-2592 60505-2592-0 10 BLISTER PACK in 1 CARTON (60505-2592-0) > 10 TABLET in 1 BLISTER PACK
alendronate sodium
TABLET;ORAL 077982 ANDA Apotex Corp. 60505-2592 60505-2592-1 100 TABLET in 1 BOTTLE (60505-2592-1)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 5MG BASE
Approval Date:Aug 4, 2008TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 10MG BASE
Approval Date:Aug 4, 2008TE:ABRLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 35MG BASE
Approval Date:Aug 4, 2008TE:ABRLD:No

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