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Generated: January 18, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 064082

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NDA 064082 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 064082
Tradename:AMPICILLIN TRIHYDRATE
Applicant:Sandoz
Ingredient:ampicillin/ampicillin trihydrate
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 064082
Suppliers and Packaging for NDA: 064082
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
AMPICILLIN TRIHYDRATE ampicillin/ampicillin trihydrate CAPSULE;ORAL 064082 ANDA Sandoz Inc 0781-2144 0781-2144-01 100 CAPSULE in 1 BOTTLE (0781-2144-01)
AMPICILLIN TRIHYDRATE ampicillin/ampicillin trihydrate CAPSULE;ORAL 064082 ANDA Sandoz Inc 0781-2144 0781-2144-05 500 CAPSULE in 1 BOTTLE (0781-2144-05)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 250MG BASE
Approval Date:Aug 29, 1995TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 500MG BASE
Approval Date:Aug 29, 1995TE:ABRLD:No

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