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Generated: November 20, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 061147

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NDA 061147 describes SUMYCIN, which is a drug marketed by Par Pharm and Apothecon 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:
1
Applicant:
1
Ingredient:
1
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 49884-732-01 100 TABLET, FILM COATED in 1 BOTTLE (49884-732-01)
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)

Summary for product number 001

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

Summary for product number 002

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

Summary 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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