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Details for New Drug Application (NDA): 062882

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NDA 062882 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 ten suppliers. Additional details are available on the AMPICILLIN TRIHYDRATE profile page.

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

Summary for NDA: 062882

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/ampicillin trihydrate
CAPSULE;ORAL 062882 ANDA Blenheim Pharmacal, Inc. 10544-122 10544-122-28 28 CAPSULE in 1 BOTTLE (10544-122-28)
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)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 500MG BASE
Approval Date:Feb 25, 1988TE:ABRLD:Yes

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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.