New Formulations
|
Established Name |
Proprietary Name |
Applicant |
Approval |
|
Trazodone Hydrochloride |
OLEPTRO |
Labopharm |
|
|
Aztreonam for inhalation solution |
CAYSTON |
Gilead |
|
|
Docetaxel for Injection |
DOCEFREZ |
Sun Pharma Global |
|
|
Indomethacin for Injection |
Not available |
APP Pharmaceuticals |
|
|
Doxepin hydrochloride tablets |
Silenor |
Somaxon Pharmaceuticals |
|
|
Miconazole buccal tablets |
ORAVIG |
BioAlliance Pharma |
|
|
Tramadol hydrochloride extended-release capsules |
Not available |
Cipher Pharmaceuticals |
|
|
Cefepime for Injection, USP and Dextrose Injection, USP in the Duplex® container |
Not available |
B. Braun Medical, |
|
|
Ondansetron oral soluble film |
ZUPLENZ |
Par Pharmaceutical |
|
|
Clindamycin phosphate and tretinoin Gel |
Veltin |
Stiefel |
|
|
Calcipotriene Foam |
Soriluxâ„¢ |
Stiefel |
|
|
Acetaminophen Injection |
Ofirmev |
Cadence Pharmaceuticals |
|
|
Baclofen Injection |
Gablofen |
CNS Therapeutics |
|
|
Testosterone topical solution |
Axironâ„¢ |
Axrux Pharma |
|
|
|
|
|
|
New Molecular Entity
|
Established Name |
Proprietary Name |
Applicant |
Approval |
|
|
|
|
|
|
|
|
|
|
New Combinations
|
Established Name |
Proprietary Name |
Applicant |
Approval |
|
Articaine hydrochloride 4% and epinephrine |
Not available |
Pierrel S.p.A. |
|
|
Ibuprofen /10 mg phenylephrine HCl tablets. |
Advil® Congestion Relief |
Wyeth Consumer Healthcare |
|
|
Dutasteride /tamsulosin hydrochloride |
Jalynâ„¢ |
GlaxoSmithKline |
|
|
Aliskiren/amlodipine |
Tekamlo |
Novartis |
|
|
Drospirenone/ethinyl estradiol/levomefolate calcium and levomefolate calcium tablets |
Beyaz |
Bayer HealthCare |
|
|
Dextromethorphan hydrobromide and quinidine sulfate |
Nuedexta |
Avanir Pharmaceuticals |
|
|
Drospirenone/ethinyl estradiol/levomefolate calcium tablets and levomefolate calcium tablets |
Safyral |
Bayer Healthcare |
Drugs Already Marketed, but Without an Approved NDA
|
Established Name |
Proprietary Name |
Applicant |
Approval |
|
Pancrelipase Delayed-Release Capsules |
Pancreaze |
Ortho-McNeil-Janssen Pharmaceuticals |
|
|
|
|
|
|