Details for New Drug Application (NDA): 206006
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The generic ingredient in LANSOPRAZOLE, AMOXICILLIN AND CLARITHROMYCIN (COPACKAGED) is amoxicillin; clarithromycin; lansoprazole. There are forty-six drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the amoxicillin; clarithromycin; lansoprazole profile page.
Summary for 206006
Tradename: | LANSOPRAZOLE, AMOXICILLIN AND CLARITHROMYCIN (COPACKAGED) |
Applicant: | Rising |
Ingredient: | amoxicillin; clarithromycin; lansoprazole |
Patents: | 0 |
Suppliers and Packaging for NDA: 206006
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
LANSOPRAZOLE, AMOXICILLIN AND CLARITHROMYCIN (COPACKAGED) | amoxicillin; clarithromycin; lansoprazole | CAPSULE, TABLET, CAPSULE, DELAYED REL PELLETS;ORAL | 206006 | ANDA | Rising Pharma Holdings, Inc. | 57237-001 | 57237-001-14 | 14 BLISTER PACK in 1 CARTON (57237-001-14) / 1 KIT in 1 BLISTER PACK (57237-001-01) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE, TABLET, CAPSULE, DELAYED REL PELLETS;ORAL | Strength | 500MG;500MG;30MG | ||||
Approval Date: | Oct 7, 2016 | TE: | AB | RLD: | No |
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