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Generated: April 22, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 062882

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NDA 062882 describes AMPICILLIN TRIHYDRATE, which is a drug marketed by Am Antibiotics, Dava Pharms Inc, Ivax Sub Teva Pharms, Lederle, Mylan, Purepac Pharm, Sandoz, Teva, and Vitarine, and is included in fifteen NDAs. It is available from eight suppliers. Additional details are available on the AMPICILLIN TRIHYDRATE profile page.

The generic ingredient in AMPICILLIN TRIHYDRATE is ampicillin/ampicillin trihydrate. Eight suppliers are listed for this compound. Additional details are available on the ampicillin/ampicillin trihydrate profile page.
Summary for 062882
Applicant:Dava Pharms Inc
Ingredient:ampicillin/ampicillin trihydrate
Formulation / Manufacturing:see details
Pharmacology for NDA: 062882
Suppliers and Packaging for NDA: 062882
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
AMPICILLIN TRIHYDRATE ampicillin/ampicillin trihydrate CAPSULE;ORAL 062882 ANDA Blenheim Pharmacal, Inc. 10544-122 10544-122-28 28 CAPSULE in 1 BOTTLE (10544-122-28)
AMPICILLIN TRIHYDRATE ampicillin/ampicillin trihydrate CAPSULE;ORAL 062882 ANDA H.J. Harkins Company, Inc. 52959-389 52959-389-20 20 CAPSULE in 1 BOTTLE, PLASTIC (52959-389-20)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 500MG BASE
Approval Date:Feb 25, 1988TE:ABRLD:No

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