| Application # | Type | Sponsor | Notes | Product # | Drug Name | Form | Strength | Active Ingredient | Approval Date | Marketing Status | Reference Standard |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 050824 | NDA | CUMBERLAND | 001 | OMECLAMOX-PAK | 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| 500MG,N/A,N/A;N/A,500MG,N/A;N/A,N/A,20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | AMOXICILLIN; CLARITHROMYCIN; OMEPRAZOLE | 2011-02-08 | Discontinued | No | |
| 022110 | NDA | CUMBERLAND | 001 | VIBATIV | POWDER;INTRAVENOUS | EQ 250MG BASE/VIAL | TELAVANCIN HYDROCHLORIDE | 2009-09-11 | Discontinued | No | |
| 002 | VIBATIV | POWDER;INTRAVENOUS | EQ 750MG BASE/VIAL | TELAVANCIN HYDROCHLORIDE | 2009-09-11 | Prescription | Yes | ||||
| 022348 | NDA | CUMBERLAND PHARMS | 001 | CALDOLOR | SOLUTION;INTRAVENOUS | 400MG/4ML (100MG/ML) | IBUPROFEN | 2009-06-11 | Discontinued | No | |
| 002 | CALDOLOR | SOLUTION;INTRAVENOUS | 800MG/8ML (100MG/ML) | IBUPROFEN | 2009-06-11 | Prescription | Yes | ||||
| 003 | CALDOLOR | SOLUTION;INTRAVENOUS | 800MG/200ML (4MG/ML) | IBUPROFEN | 2009-06-11 | Prescription | Yes | ||||
| 022198 | NDA | CUMBERLAND | 001 | SANCUSO | FILM, EXTENDED RELEASE;TRANSDERMAL | 3.1MG/24HR | GRANISETRON | 2008-09-12 | Prescription | Yes | |
| 022016 | NDA | CUMBERLAND PHARMS | 001 | VAPRISOL | INJECTABLE; INJECTION | 20MG | CONIVAPTAN HYDROCHLORIDE | 2007-02-28 | Prescription | No | |
| 021697 | NDA | CUMBERLAND | 001 | VAPRISOL | INJECTABLE;INTRAVENOUS | 20MG/4ML (5MG/ML) | CONIVAPTAN HYDROCHLORIDE | 2005-12-29 | Discontinued | No | |
| 002 | VAPRISOL IN 5% DEXTROSE IN PLASTIC CONTAINER | INJECTABLE;INTRAVENOUS | 20MG/100ML (0.2MG/ML) | CONIVAPTAN HYDROCHLORIDE | 2005-12-29 | Prescription | Yes | ||||
| 021539 | NDA | CUMBERLAND PHARMS | 001 | ACETADOTE | INJECTABLE;INTRAVENOUS | 6GM/30ML (200MG/ML) | ACETYLCYSTEINE | 2004-01-23 | Prescription | Yes | |
| 074712 | ANDA | CUMBERLAND PHARMS | 001 | LACTULOSE | FOR SOLUTION;ORAL | 10GM/PACKET | LACTULOSE | 1997-12-10 | Prescription | Yes | |
| 002 | LACTULOSE | FOR SOLUTION;ORAL | 20GM/PACKET | LACTULOSE | 1997-12-10 | Prescription | Yes |