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Generated: April 20, 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 Bio Ag, Mylan Pharms Inc, Amneal Pharms Co, 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-two NDAs. It is available from thirty-four suppliers. Additional details are available on the ERYTHROMYCIN profile page.

The generic ingredient in ERYTHROMYCIN is erythromycin stearate. There are one hundred and two 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 Rebel Distributors Corp 21695-387 E 21695-387-30
ERYTHROMYCIN erythromycin TABLET;ORAL 061621 ANDA Rebel Distributors Corp 21695-387 E 21695-387-28

Profile for product number 001

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

Profile for product number 002

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

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