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Details for New Drug Application (NDA): 064082

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NDA 064082 describes AMPICILLIN TRIHYDRATE, which is a drug marketed by Am Antibiotics, Teva, Lederle, Mylan, Purepac Pharm, Ivax Sub Teva Pharms, Dava Pharms Inc, Sandoz, and Vitarine, and is included in fifteen NDAs. It is available from nine suppliers. Additional details are available on the AMPICILLIN TRIHYDRATE profile page.

The generic ingredient in AMPICILLIN TRIHYDRATE is ampicillin/ampicillin trihydrate. Nine suppliers are listed for this compound. Additional details are available on the ampicillin/ampicillin trihydrate profile page.

Summary for NDA: 064082

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/ampicillin trihydrate
CAPSULE;ORAL 064082 ANDA Sandoz Inc 0781-2144 0781-2144-01 100 CAPSULE in 1 BOTTLE (0781-2144-01)
ampicillin/ampicillin trihydrate
CAPSULE;ORAL 064082 ANDA Sandoz Inc 0781-2144 0781-2144-05 500 CAPSULE in 1 BOTTLE (0781-2144-05)

Summary for product number 001

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

Summary for product number 002

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

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.