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Details for New Drug Application (NDA): 061621

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NDA 061621 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: 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

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 16590-091-60 60 TABLET, FILM COATED in 1 BOTTLE (16590-091-60)

Summary for product number 001

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

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength500MG
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:Yes


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