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Serving leading biopharmaceutical companies globally:

Chinese Patent Office
Express Scripts
Novartis
Baxter
Harvard Business School
Moodys
Colorcon
Dow
Deloitte
Argus Health

Generated: January 22, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 061621

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NDA 061621 describes ERYTHROMYCIN, which is a drug marketed by Arbor Pharms Llc, Barr, Fougera Pharms, Perrigo Co, Teligent Pharma Inc, Elkins Sinn, Akorn, Bausch And Lomb, Perrigo Co Tennessee, Pharmaderm, Pharmafair, Paddock Llc, Alpharma Us Pharms, Lilly, Perrigo New York, Renaissance Pharma, Wockhardt, Mylan Pharms Inc, Lyne, Tolmar, Ivax Sub Teva Pharms, Watson Labs, G And W Labs Inc, Life Labs, Ani Pharms Inc, Dista, Naska, Parke Davis, Mylan, Abraxis Pharm, Baxter Hlthcare, Teva Parenteral, Lederle, and Purepac Pharm, and is included in sixty NDAs. It is available from thirty-five suppliers. Additional details are available on the ERYTHROMYCIN profile page.

The generic ingredient in ERYTHROMYCIN is erythromycin stearate. There are one hundred and one drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the erythromycin stearate profile page.
Summary for 061621
Tradename:ERYTHROMYCIN
Applicant:Arbor Pharms Llc
Ingredient:erythromycin
Patents:0
Therapeutic Class:Antibacterials
Formulation / Manufacturing:see details
Pharmacology for NDA: 061621
Ingredient-typeMacrolides
Physiological EffectDecreased Sebaceous Gland Activity
Medical Subject Heading (MeSH) Categories for 061621
Suppliers and Packaging for NDA: 061621
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ERYTHROMYCIN erythromycin TABLET;ORAL 061621 ANDA STAT RX USA LLC 16590-091 16590-091-30 30 TABLET, FILM COATED in 1 BOTTLE (16590-091-30)
ERYTHROMYCIN erythromycin TABLET;ORAL 061621 ANDA STAT RX USA LLC 16590-091 16590-091-90 90 TABLET, FILM COATED in 1 BOTTLE (16590-091-90)

Profile for product number 001

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

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength500MG
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:No

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Serving leading biopharmaceutical companies globally:

Teva
Fuji
Julphar
Mallinckrodt
Fish and Richardson
Dow
Chubb
Chinese Patent Office
Queensland Health

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