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Deloitte
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Generated: October 23, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 203458

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NDA 203458 describes METRONIDAZOLE, which is a drug marketed by Tolmar, Intl Medication, Able, West-ward Pharms Int, Fougera Pharms, Superpharm, Flamingo Pharms, Ivax Sub Teva Pharms, Mutual Pharm, Taro, Sandoz, Halsey, Par Pharm, Alembic Pharms Ltd, Teva Pharms Usa, LNK, Chartwell Molecules, Pliva, Watson Labs, Vivimed Global, Watson Labs Inc, Appco Pharma Llc, G And W Labs, Taro Pharm, Unichem Labs Ltd, Zydus Pharms Usa Inc, Strides Pharma, Abraxis Pharm, Innogenix, Aurobindo Pharma Ltd, G And W Labs Inc, Orit Labs Llc, Abbott, Lupin Ltd, Mylan Labs Ltd, Baxter Hlthcare Corp, and Hospira, and is included in fifty-six NDAs. It is available from sixty-nine suppliers. Additional details are available on the METRONIDAZOLE profile page.

The generic ingredient in METRONIDAZOLE is metronidazole hydrochloride. There are eighteen drug master file entries for this compound. Additional details are available on the metronidazole hydrochloride profile page.

Summary for NDA: 203458

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:0
Therapeutic Class:Antibacterials
Formulation / Manufacturing:see details

Pharmacology for NDA: 203458

Ingredient-typeNitroimidazoles

Suppliers and Packaging for NDA: 203458

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
METRONIDAZOLE
metronidazole
TABLET;ORAL 203458 ANDA Apotheca Inc. 12634-172 12634-172-00 10 TABLET, FILM COATED in 1 BOTTLE (12634-172-00)
METRONIDAZOLE
metronidazole
TABLET;ORAL 203458 ANDA Apotheca Inc. 12634-172 12634-172-01 100 TABLET, FILM COATED in 1 BOTTLE (12634-172-01)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength250MG
Approval Date:Jan 22, 2014TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength500MG
Approval Date:Jan 22, 2014TE:ABRLD:No


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