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Serving 500+ biopharmaceutical companies globally:

Baxter
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Generated: June 25, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 077025

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NDA 077025 describes NITROFURANTOIN, which is a drug marketed by Elkins Sinn, Sun Pharm Inds, Mylan, Watson Labs, Sandoz, Impax Labs Inc, Nostrum Labs Inc, Ivax Sub Teva Pharms, Amneal Pharms, Actavis Mid Atlantic, Whiteworth Town Plsn, Novel Labs Inc, Actavis Labs Fl Inc, Watson Labs Inc, and Ranbaxy Labs Ltd, and is included in twenty-seven NDAs. It is available from twenty-three suppliers. Additional details are available on the NITROFURANTOIN profile page.

The generic ingredient in NITROFURANTOIN is nitrofurantoin; nitrofurantoin, macrocrystalline. There are nineteen drug master file entries for this compound. Twenty-eight suppliers are listed for this compound. Additional details are available on the nitrofurantoin; nitrofurantoin, macrocrystalline profile page.

Summary for NDA: 077025

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:1
Formulation / Manufacturing:see details

Pharmacology for NDA: 077025

Ingredient-typeNitrofurans

Suppliers and Packaging for NDA: 077025

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
NITROFURANTOIN
nitrofurantoin, macrocrystalline
CAPSULE;ORAL 077025 ANDA Mylan Pharmaceuticals Inc. 0378-1700 0378-1700-01 100 CAPSULE in 1 BOTTLE, PLASTIC (0378-1700-01)
NITROFURANTOIN
nitrofurantoin, macrocrystalline
CAPSULE;ORAL 077025 ANDA Mylan Pharmaceuticals Inc. 0378-1700 0378-1700-05 500 CAPSULE in 1 BOTTLE, PLASTIC (0378-1700-05)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength100MG
Approval Date:Aug 18, 2004TE:ABRLD:No


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Serving 500+ biopharmaceutical companies globally:

Daiichi Sankyo
Express Scripts
Johnson and Johnson
Cerilliant
Cipla
UBS
Fish and Richardson
Teva
Farmers Insurance
Moodys

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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