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Mallinckrodt
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Generated: November 18, 2017

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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 Co, Akorn, Pharmafair, Fougera Pharms, Arbor Pharms Llc, Wockhardt, Alpharma Us Pharms, Renaissance Pharma, Mylan Pharms Inc, Lilly, Perrigo New York, Bausch And Lomb, Pharmaderm, Perrigo Co Tennessee, Teligent Pharma Inc, 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 sixty NDAs. It is available from thirty-five suppliers. Additional details are available on the ERYTHROMYCIN profile page.

The generic ingredient in ERYTHROMYCIN is erythromycin stearate. There are ninety-nine 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:
1
Applicant:
1
Ingredient:
1
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:No


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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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