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Generated: September 25, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 077547

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NDA 077547 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, Allied Pharma Inc, Aurobindo Pharma Ltd, G And W Labs Inc, Orit Labs Llc, Abbott, Mylan Labs Ltd, Baxter Hlthcare Corp, and Hospira, and is included in fifty-five 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: 077547

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

Pharmacology for NDA: 077547

Ingredient-typeNitroimidazoles

Suppliers and Packaging for NDA: 077547

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
METRONIDAZOLE
metronidazole
GEL;TOPICAL 077547 ANDA Impax Generics 0115-1474 0115-1474-46 1 TUBE in 1 CARTON (0115-1474-46) > 45 g in 1 TUBE
METRONIDAZOLE
metronidazole
GEL;TOPICAL 077547 ANDA Rebel Distributors Corp 42254-069 42254-069-45 1 TUBE in 1 CARTON (42254-069-45) > 45 g in 1 TUBE

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:GEL;TOPICALStrength0.75%
Approval Date:Jul 13, 2006TE:ABRLD:No


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Serving 500+ biopharmaceutical companies globally:

Cerilliant
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Express Scripts
Julphar
Fuji
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Dow

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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