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Generated: December 16, 2018

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Details for New Drug Application (NDA): 064184

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NDA 064184 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-two 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. Five suppliers are listed for this compound. Additional details are available on the erythromycin stearate profile page.
Summary for 064184
Tradename:ERYTHROMYCIN
Applicant:Fougera Pharms
Ingredient:erythromycin
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 064184
Medical Subject Heading (MeSH) Categories for 064184
Suppliers and Packaging for NDA: 064184
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ERYTHROMYCIN erythromycin GEL;TOPICAL 064184 ANDA E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. 0168-0216 0168-0216-30 30 g in 1 TUBE (0168-0216-30)
ERYTHROMYCIN erythromycin GEL;TOPICAL 064184 ANDA E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. 0168-0216 0168-0216-60 60 g in 1 TUBE (0168-0216-60)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:GEL;TOPICALStrength2%
Approval Date:Sep 30, 1997TE:ATRLD:No

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