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Details for New Drug Application (NDA): 202865

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NDA 202865 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, Eurohlth Intl Sarl, 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: 202865

Hospira Inc
ampicillin sodium
Therapeutic Class:Antibacterials

Pharmacology for NDA: 202865


Suppliers and Packaging for NDA: 202865

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ampicillin sodium
INJECTABLE;INJECTION 202865 ANDA Hospira, Inc. 0409-2686 0409-2686-01 10 BOTTLE in 1 CARTON (0409-2686-01) > 1 INJECTION, POWDER, FOR SOLUTION in 1 BOTTLE (0409-2686-11)

Summary for product number 001

Approval Date:Sep 4, 2015TE:APRLD:No

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