Cumberland Pharmaceuticals Inc. (CPIX)
FDA Applications
Note: This list only includes applications that have been responded to by the FDA.
| Application | Product Name | Active Ingredient | Form | Strength | Status | ||
|---|---|---|---|---|---|---|---|
| ANDA074712 - CUMBERLAND PHARMS | |||||||
| LACTULOSE | LACTULOSE | FOR SOLUTION;ORAL | 10GM/PACKET | Prescription | |||
| LACTULOSE | LACTULOSE | FOR SOLUTION;ORAL | 20GM/PACKET | Prescription | |||
| NDA050824 - CUMBERLAND | |||||||
| OMECLAMOX-PAK | AMOXICILLIN; CLARITHROMYCIN; OMEPRAZOLE | CAPSULE, TABLET, CAPSULE, DELAYED RELEASE;ORAL | 500MG,N/A,N/A;N/A,500MG,N/A;N/A,N/A,20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| NDA022348 - CUMBERLAND PHARMS | |||||||
| CALDOLOR | IBUPROFEN | SOLUTION;INTRAVENOUS | 400MG/4ML (100MG/ML) | Discontinued | |||
| CALDOLOR | IBUPROFEN | SOLUTION;INTRAVENOUS | 800MG/8ML (100MG/ML) | Prescription | |||
| CALDOLOR | IBUPROFEN | SOLUTION;INTRAVENOUS | 800MG/200ML (4MG/ML) | Prescription | |||
| NDA022198 - CUMBERLAND | |||||||
| SANCUSO | GRANISETRON | FILM, EXTENDED RELEASE;TRANSDERMAL | 3.1MG/24HR | Prescription | |||
| NDA022110 - CUMBERLAND | |||||||
| VIBATIV | TELAVANCIN HYDROCHLORIDE | POWDER;INTRAVENOUS | EQ 250MG BASE/VIAL | Discontinued | |||
| VIBATIV | TELAVANCIN HYDROCHLORIDE | POWDER;INTRAVENOUS | EQ 750MG BASE/VIAL | Prescription | |||
| NDA022016 - CUMBERLAND PHARMS | |||||||
| VAPRISOL | CONIVAPTAN HYDROCHLORIDE | INJECTABLE; INJECTION | 20MG | Prescription | |||
| NDA021697 - CUMBERLAND | |||||||
| VAPRISOL | CONIVAPTAN HYDROCHLORIDE | INJECTABLE;INTRAVENOUS | 20MG/4ML (5MG/ML) | Discontinued | |||
| VAPRISOL IN 5% DEXTROSE IN PLASTIC CONTAINER | CONIVAPTAN HYDROCHLORIDE | INJECTABLE;INTRAVENOUS | 20MG/100ML (0.2MG/ML) | Prescription | |||
| NDA021539 - CUMBERLAND PHARMS | |||||||
| ACETADOTE | ACETYLCYSTEINE | INJECTABLE;INTRAVENOUS | 6GM/30ML (200MG/ML) | Prescription | |||