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Details for New Drug Application (NDA): 206006

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NDA 206006 describes LANSOPRAZOLE, AMOXICILLIN AND CLARITHROMYCIN, which is a drug marketed by Rising Pharms Inc, Teva Pharms Usa, and Sandoz Inc, and is included in three NDAs. It is available from two suppliers. Additional details are available on the LANSOPRAZOLE, AMOXICILLIN AND CLARITHROMYCIN profile page.

The generic ingredient in LANSOPRAZOLE, AMOXICILLIN AND CLARITHROMYCIN is amoxicillin; clarithromycin; lansoprazole. There are forty-three drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the amoxicillin; clarithromycin; lansoprazole profile page.

Summary for NDA: 206006

Formulation / Manufacturing:see details

Suppliers and Packaging for NDA: 206006

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
amoxicillin; clarithromycin; lansoprazole
CAPSULE, CAPSULE, DELAYED REL PELLETS, TABLET;ORAL 206006 ANDA Citron Pharma LLC 57237-001 57237-001-14 14 BLISTER PACK in 1 CARTON (57237-001-14) > 1 KIT in 1 BLISTER PACK (57237-001-01)

Summary for product number 001

Approval Date:Oct 7, 2016TE:ABRLD:No

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