Details for New Drug Application (NDA): 206006
NDA 206006 describes LANSOPRAZOLE, AMOXICILLIN AND CLARITHROMYCIN (COPACKAGED), which is a drug marketed by Ani Pharms, Rising, and Sandoz, and is included in three NDAs. It is available from one supplier. Additional details are available on the LANSOPRAZOLE, AMOXICILLIN AND CLARITHROMYCIN (COPACKAGED) profile page.
The generic ingredient in LANSOPRAZOLE, AMOXICILLIN AND CLARITHROMYCIN (COPACKAGED) is amoxicillin; clarithromycin; lansoprazole. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the amoxicillin; clarithromycin; lansoprazole profile page.
The generic ingredient in LANSOPRAZOLE, AMOXICILLIN AND CLARITHROMYCIN (COPACKAGED) is amoxicillin; clarithromycin; lansoprazole. There is one drug master file entry 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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