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Generated: July 24, 2017

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Details for New Drug Application (NDA): 062797

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NDA 062797 describes AMPICILLIN SODIUM, which is a drug marketed by Istituto Bio Ita Spa, Watson Labs Inc, Mylan Labs Ltd, Intl Medication, Consolidated Pharm, Sandoz, Hanford Gc, Antibiotice, Apothecon, Hospira Inc, Lilly, Sagent Pharms, Acs Dobfar Spa, West-ward Pharms Int, and Aurobindo Pharma, and is included in thirty-two NDAs. It is available from sixteen suppliers. Additional details are available on the AMPICILLIN SODIUM profile page.

The generic ingredient in AMPICILLIN SODIUM is ampicillin sodium. There are sixty-nine drug master file entries for this compound. Sixteen suppliers are listed for this compound. Additional details are available on the ampicillin sodium profile page.

Summary for NDA: 062797

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:1
Therapeutic Class:Antibacterials
Formulation / Manufacturing:see details

Pharmacology for NDA: 062797

Ingredient-typePenicillins

Suppliers and Packaging for NDA: 062797

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
AMPICILLIN SODIUM
ampicillin sodium
INJECTABLE;INJECTION 062797 ANDA Cardinal Health 55154-9384 55154-9384-5 5 VIAL in 1 BAG (55154-9384-5) > 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL
AMPICILLIN SODIUM
ampicillin sodium
INJECTABLE;INJECTION 062797 ANDA APP Pharmaceuticals, Inc. 63323-399 63323-399-23 10 VIAL in 1 CARTON (63323-399-23) > 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 125MG BASE/VIAL
Approval Date:Jul 12, 1993TE:APRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 2GM BASE/VIAL
Approval Date:Jul 12, 1993TE:APRLD:No


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Serving 500+ biopharmaceutical companies globally:

Teva
Baxter
UBS
Moodys
Merck
Colorcon
Deloitte
US Army
Mallinckrodt
McKesson

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.

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