Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Last Updated: November 19, 2019

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, Amneal Pharms Co, Lyne, Tolmar, Ivax Sub Teva Pharms, Watson Labs, Acp Nimble, Life Labs, Ani Pharms Inc, Dista, Naska, Parke Davis, Abraxis Pharm, Baxter Hlthcare, Teva Parenteral, Lederle, and Purepac Pharm, and is included in sixty-three NDAs. It is available from twenty-seven suppliers. Additional details are available on the ERYTHROMYCIN profile page.

The generic ingredient in ERYTHROMYCIN is erythromycin stearate. There are one hundred and three drug master file entries for this compound. Three 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
Formulation / Manufacturing:see details
Pharmacology for NDA: 061621
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 Arbor Pharmaceuticals, Inc. 24338-102 24338-102-03 30 TABLET, FILM COATED in 1 BOTTLE (24338-102-03)
ERYTHROMYCIN erythromycin TABLET;ORAL 061621 ANDA Arbor Pharmaceuticals, Inc. 24338-102 24338-102-13 100 TABLET, FILM COATED in 1 BOTTLE (24338-102-13)

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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