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Citi
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Teva
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US Department of Justice
Daiichi Sankyo
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Generated: April 23, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 061147

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NDA 061147 describes SUMYCIN, which is a drug marketed by Apothecon and Par Pharm and is included in three NDAs. It is available from one supplier. Additional details are available on the SUMYCIN profile page.

The generic ingredient in SUMYCIN is tetracycline hydrochloride. There are ninety-nine drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the tetracycline hydrochloride profile page.
Summary for 061147
Tradename:SUMYCIN
Applicant:Par Pharm
Ingredient:tetracycline hydrochloride
Patents:0
Therapeutic Class:Antibacterials
Formulation / Manufacturing:see details
Pharmacology for NDA: 061147
Ingredient-typeTetracyclines
Suppliers and Packaging for NDA: 061147
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
SUMYCIN tetracycline hydrochloride TABLET;ORAL 061147 ANDA Par Pharmaceutical, Inc. 49884-732 N 49884-732-10
SUMYCIN tetracycline hydrochloride TABLET;ORAL 061147 ANDA Par Pharmaceutical, Inc. 49884-732 N 49884-732-01

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength250MG
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength100MG
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength50MG
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Harvard Business School
Daiichi Sankyo
Julphar
Cipla
Fish and Richardson
Covington
Fuji
Queensland Health
AstraZeneca

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