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Generated: December 15, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 076852

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NDA 076852 describes DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE, which is a drug marketed by Actavis Elizabeth, Impax Labs, Teva, Alvogen Malta, Aurolife Pharma Llc, Barr, Epic Pharma Llc, Mallinckrodt Inc, Mylan Pharms Inc, Nesher Pharms, Sandoz, Sun Pharm Industries, and Teva Pharms, and is included in fifteen NDAs. It is available from seventeen suppliers. Additional details are available on the DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE profile page.

The generic ingredient in DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE is amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate. There are fifty-three drug master file entries for this compound. Twenty-two suppliers are listed for this compound. Additional details are available on the amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate profile page.

Summary for 076852

Tradename:1
Applicant:1
Ingredient:1
Patents:0
Formulation / Manufacturing:see details

Pharmacology for NDA: 076852

Suppliers and Packaging for NDA: 076852

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate CAPSULE, EXTENDED RELEASE;ORAL 076852 ANDA Impax Generics 0115-1486 0115-1486-01 100 CAPSULE in 1 BOTTLE (0115-1486-01)
DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate CAPSULE, EXTENDED RELEASE;ORAL 076852 ANDA Impax Generics 0115-1487 0115-1487-01 100 CAPSULE in 1 BOTTLE (0115-1487-01)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, EXTENDED RELEASE;ORALStrength1.25MG;1.25MG;1.25MG;1.25MG
Approval Date:Feb 16, 2016TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, EXTENDED RELEASE;ORALStrength2.5MG;2.5MG;2.5MG;2.5MG
Approval Date:Feb 16, 2016TE:ABRLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, EXTENDED RELEASE;ORALStrength3.75MG;3.75MG;3.75MG;3.75MG
Approval Date:Feb 16, 2016TE:ABRLD:No


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