Details for New Drug Application (NDA): 050824
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NDA 050824 describes OMECLAMOX-PAK, which is a drug marketed by Cumberland and is included in one NDA. It is available from one supplier. Additional details are available on the OMECLAMOX-PAK profile page.
The generic ingredient in OMECLAMOX-PAK is amoxicillin; clarithromycin; omeprazole. 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; omeprazole profile page.
The generic ingredient in OMECLAMOX-PAK is amoxicillin; clarithromycin; omeprazole. 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; omeprazole profile page.
Summary for 050824
| Tradename: | OMECLAMOX-PAK |
| Applicant: | Cumberland |
| Ingredient: | amoxicillin; clarithromycin; omeprazole |
| Patents: | 0 |
Suppliers and Packaging for NDA: 050824
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| OMECLAMOX-PAK | amoxicillin; clarithromycin; omeprazole | CAPSULE, TABLET, CAPSULE, DELAYED RELEASE;ORAL | 050824 | NDA | Cumberland Pharmaceuticals Inc. | 66220-422 | 66220-422-01 | 1 KIT in 1 BLISTER PACK (66220-422-01) |
| OMECLAMOX-PAK | amoxicillin; clarithromycin; omeprazole | CAPSULE, TABLET, CAPSULE, DELAYED RELEASE;ORAL | 050824 | NDA | Cumberland Pharmaceuticals Inc. | 66220-422 | 66220-422-02 | 10 BLISTER PACK in 1 CARTON (66220-422-02) / 1 KIT in 1 BLISTER PACK |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | CAPSULE, TABLET, CAPSULE, DELAYED RELEASE;ORAL | Strength | 500MG,N/A,N/A;N/A,500MG,N/A;N/A,N/A,20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
| Approval Date: | Feb 8, 2011 | TE: | RLD: | Yes | |||||
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