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Serving leading biopharmaceutical companies globally:

Merck
Novartis
Fuji
Dow
Baxter
Julphar
Healthtrust
Moodys
McKinsey
Medtronic

Generated: January 21, 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. Sixteen 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 49884-732-10 1000 TABLET, FILM COATED in 1 BOTTLE (49884-732-10)
SUMYCIN tetracycline hydrochloride TABLET;ORAL 061147 ANDA Par Pharmaceutical, Inc. 49884-732 49884-732-01 100 TABLET, FILM COATED in 1 BOTTLE (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 leading biopharmaceutical companies globally:

Moodys
Queensland Health
Federal Trade Commission
Citi
Farmers Insurance
US Department of Justice
Baxter
McKinsey
Daiichi Sankyo

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