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Details for New Drug Application (NDA): 062447

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NDA 062447 describes ERYTHROMYCIN, which is a drug marketed by Paddock Llc, Perrigo, Versapharm, Pharmafair, Fougera Pharms, Arbor Pharms Llc, Wockhardt, Alpharma Us Pharms, Renaissance Pharma, Akorn, Lilly, Perrigo New York, Bausch And Lomb, Pharmaderm, Perrigo Co Tennessee, Elkins Sinn, Barr, Tolmar, Lyne, Ivax Sub Teva Pharms, Life Labs, G And W Labs Inc, Watson Labs, Parke Davis, Mylan, Ani Pharms Inc, Naska, Dista, Abraxis Pharm, Teva Parenteral, Baxter Hlthcare, Purepac Pharm, and Lederle, and is included in fifty-nine 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 ninety-seven drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the erythromycin stearate profile page.

Summary for NDA: 062447

Tradename:
ERYTHROMYCIN
Applicant:
Perrigo Co Tennessee
Ingredient:
erythromycin
Patents:0
Therapeutic Class:Antibacterials
Formulation / Manufacturing:see details

Pharmacology for NDA: 062447

Ingredient-typeMacrolides
Physiological EffectDecreased Sebaceous Gland Activity

Suppliers and Packaging for NDA: 062447

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ERYTHROMYCIN
erythromycin
OINTMENT;OPHTHALMIC 062447 ANDA Paddock Laboratories, LLC 0574-4023 0574-4023-11 1 TUBE in 1 CARTON (0574-4023-11) > 1 g in 1 TUBE
ERYTHROMYCIN
erythromycin
OINTMENT;OPHTHALMIC 062447 ANDA Paddock Laboratories, LLC 0574-4024 0574-4024-35 1 TUBE in 1 CARTON (0574-4024-35) > 3.5 g in 1 TUBE

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:OINTMENT;OPHTHALMICStrength0.5%
Approval Date:Sep 26, 1983TE:ATRLD:Yes


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