Patients
December 2008 FDA New Drug Approval Report
Drug Name and FDA Appl. # |
Suppl. # |
Active Ingredients |
Company |
Approval Type |
Approval Date |
|---|---|---|---|---|---|
|
PRILOSEC (NDA # 019810) |
087 | OMEPRAZOLE | ASTRAZENECA | Labeling Revision | 12/01/2008 |
|
ACULAR LS (NDA # 021528) |
005 | KETOROLAC TROMETHAMINE | ALLERGAN | Labeling Revision | 12/01/2008 |
|
PRILOSEC (NDA # 022056) |
001 | OMEPRAZOLE MAGNESIUM | ASTRAZENECA | Labeling Revision | 12/01/2008 |
|
BUTALBITAL ACETAMINOPHEN AND CAFFEINE (ANDA # 040864) |
000 | ACETAMINOPHEN; BUTALBITAL; CAFFEINE | CONCORD LABS NJ | Approval | 12/01/2008 |
|
DEMECLOCYCLINE HYDROCHLORIDE (ANDA # 065389) |
000 | DEMECLOCYCLINE HYDROCHLORIDE | COVENANT PHARMA INC | Approval | 12/01/2008 |
|
PERINDOPRIL ERBUMINE (ANDA # 078138) |
000 | PERINDOPRIL ERBUMINE | IVAX PHARMS INC | Tentative Approval | 12/01/2008 |
|
TIGAN (NDA # 017531) |
013 | TRIMETHOBENZAMIDE HYDROCHLORIDE | KING PHARMS | Labeling Revision | 12/02/2008 |
|
FLOMAX (NDA # 020579) |
024 | TAMSULOSIN HYDROCHLORIDE | BOEHRINGER INGELHEIM | Labeling Revision | 12/02/2008 |
|
AVANDAMET (NDA # 021410) |
025 | METFORMIN HYDROCHLORIDE; ROSIGLITAZONE MALEATE | SB PHARMCO | Labeling Revision | 12/02/2008 |
|
AVANDARYL (NDA # 021700) |
008 | GLIMEPIRIDE; ROSIGLITAZONE MALEATE | SB PHARMCO | Labeling Revision | 12/02/2008 |
|
MIRALAX (NDA # 022015) |
003 | POLYETHYLENE GLYCOL 3350 | SCHERING PLOUGH | Package Change | 12/02/2008 |
|
CARBOPLATIN (ANDA # 078631) |
000 | CARBOPLATIN | PLIVA LACHEMA | Approval | 12/02/2008 |
|
ROSIGLITAZONE MALEATE (ANDA # 078825) |
000 | ROSIGLITAZONE MALEATE | MYLAN PHARMA | Tentative Approval | 12/02/2008 |
|
CHILDREN'S ADVIL COLD (NDA # 021373) |
008 | IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE | WYETH CONS | Labeling Revision | 12/03/2008 |
|
SODIUM POLYSTYRENE SULFONATE (ANDA # 040909) |
000 | SODIUM POLYSTYRENE SULFONATE | NOVEL LABS INC | Approval | 12/03/2008 |
|
ESCITALOPRAM OXALATE (ANDA # 079062) |
000 | ESCITALOPRAM OXALATE | AUROBINDO PHARMA | Tentative Approval | 12/03/2008 |
|
PERINDOPRIL ERBUMINE (ANDA # 079070) |
000 | PERINDOPRIL ERBUMINE | AUROBINDO PHARMA | Tentative Approval | 12/03/2008 |
|
AUGMENTIN '250' (NDA # 050564) |
050 | AMOXICILLIN; CLAVULANATE POTASSIUM | GLAXOSMITHKLINE | Labeling Revision | 12/04/2008 |
|
AUGMENTIN '500' (NDA # 050564) |
050 | AMOXICILLIN; CLAVULANATE POTASSIUM | GLAXOSMITHKLINE | Labeling Revision | 12/04/2008 |
|
AUGMENTIN '125' (NDA # 050575) |
037 | AMOXICILLIN; CLAVULANATE POTASSIUM | GLAXOSMITHKLINE | Labeling Revision | 12/04/2008 |
|
AUGMENTIN '250' (NDA # 050575) |
037 | AMOXICILLIN; CLAVULANATE POTASSIUM | GLAXOSMITHKLINE | Labeling Revision | 12/04/2008 |
|
AUGMENTIN '125' (NDA # 050597) |
044 | AMOXICILLIN; CLAVULANATE POTASSIUM | GLAXOSMITHKLINE | Labeling Revision | 12/04/2008 |
|
AUGMENTIN '250' (NDA # 050597) |
044 | AMOXICILLIN; CLAVULANATE POTASSIUM | GLAXOSMITHKLINE | Labeling Revision | 12/04/2008 |
|
AUGMENTIN '875' (NDA # 050720) |
023 | AMOXICILLIN; CLAVULANATE POTASSIUM | GLAXOSMITHKLINE | Labeling Revision | 12/04/2008 |
|
AUGMENTIN '200' (NDA # 050725) |
025 | AMOXICILLIN; CLAVULANATE POTASSIUM | GLAXOSMITHKLINE | Labeling Revision | 12/04/2008 |
|
AUGMENTIN '400' (NDA # 050725) |
025 | AMOXICILLIN; CLAVULANATE POTASSIUM | GLAXOSMITHKLINE | Labeling Revision | 12/04/2008 |
|
AUGMENTIN '200' (NDA # 050726) |
019 | AMOXICILLIN; CLAVULANATE POTASSIUM | GLAXOSMITHKLINE | Labeling Revision | 12/04/2008 |
|
AUGMENTIN '400' (NDA # 050726) |
019 | AMOXICILLIN; CLAVULANATE POTASSIUM | GLAXOSMITHKLINE | Labeling Revision | 12/04/2008 |
|
BIAXIN XL (NDA # 050775) |
037 | CLARITHROMYCIN | ABBOTT | Labeling Revision | 12/04/2008 |
|
CLOBETASOL PROPIONATE (ANDA # 078223) |
000 | CLOBETASOL PROPIONATE | ACTAVIS MID ATLANTIC | Approval | 12/04/2008 |
|
DORZOLAMIDE HYDROCHLORIDE (ANDA # 078756) |
000 | DORZOLAMIDE HYDROCHLORIDE | TEVA PHARMS | Approval | 12/04/2008 |
|
DELSYM (NDA # 018658) |
023 | DEXTROMETHORPHAN POLISTIREX | ADAMS RESP THERAP | Labeling Revision | 12/05/2008 |
|
CESAMET (NDA # 018677) |
013 | NABILONE | VALEANT | Formulation Revision | 12/05/2008 |
|
HECTOROL (NDA # 021027) |
015 | DOXERCALCIFEROL | GENZYME | Formulation Revision | 12/05/2008 |
|
INFUVITE ADULT (NDA # 021163) |
016 | ALPHA-TOCOPHEROL ACETATE; ASCORBIC ACID; BIOTIN; CHOLECALCIFEROL; CYANOCOBALAMIN; DEXPANTHENOL; FOLIC ACID; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN PHOSPHATE SODIUM; THIAMINE HYDROCHLORIDE; VITAMIN A PALMITATE; VITAMIN K | SANDOZ | Control Supplement | 12/05/2008 |
|
ARIMIDEX (NDA # 022214) |
000 | ANASTROZOLE | ASTRAZENECA | Approval | 12/05/2008 |
|
RISPERIDONE (ANDA # 077860) |
000 | RISPERIDONE | COBALT LABS INC | Approval | 12/05/2008 |
|
ARIMIDEX (NDA # 020541) |
020 | ANASTROZOLE | ASTRAZENECA | Labeling Revision | 12/10/2008 |
|
ARIMIDEX (NDA # 020541) |
021 | ANASTROZOLE | ASTRAZENECA | Labeling Revision | 12/10/2008 |
|
ARIMIDEX (NDA # 020541) |
023 | ANASTROZOLE | ASTRAZENECA | Labeling Revision | 12/10/2008 |
|
CRIXIVAN (NDA # 020685) |
068 | INDINAVIR SULFATE | MERCK | Labeling Revision | 12/10/2008 |
|
OSMOPREP (NDA # 021892) |
002 | SODIUM PHOSPHATE, DIBASIC, ANHYDROUS; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE | SALIX PHARMS | Labeling Revision | 12/10/2008 |
|
ACETAZOLAMIDE SODIUM (ANDA # 040784) |
000 | ACETAZOLAMIDE SODIUM | X GEN PHARMS | Approval | 12/10/2008 |
|
ACETAZOLAMIDE (ANDA # 040904) |
000 | ACETAZOLAMIDE | ZYDUS PHARMS USA INC | Approval | 12/10/2008 |
|
E.E.S. (NDA # 050207) |
068 | ERYTHROMYCIN ETHYLSUCCINATE | ABBOTT | Labeling Revision | 12/10/2008 |
|
ERYPED (NDA # 050207) |
068 | ERYTHROMYCIN ETHYLSUCCINATE | ABBOTT | Labeling Revision | 12/10/2008 |
|
E.E.S. (NDA # 050297) |
030 | ERYTHROMYCIN ETHYLSUCCINATE | ABBOTT | Labeling Revision | 12/10/2008 |
|
ERYPED (NDA # 050297) |
030 | ERYTHROMYCIN ETHYLSUCCINATE | ABBOTT | Labeling Revision | 12/10/2008 |
|
PCE (NDA # 050611) |
032 | ERYTHROMYCIN | ABBOTT | Labeling Revision | 12/10/2008 |
|
AUGMENTIN XR (NDA # 050785) |
007 | AMOXICILLIN; CLAVULANATE POTASSIUM | GLAXOSMITHKLINE | Labeling Revision | 12/10/2008 |
|
ZERIT (NDA # 020412) |
032 | STAVUDINE | BRISTOL MYERS SQUIBB | Labeling Revision | 12/11/2008 |
|
ZERIT (NDA # 020413) |
023 | STAVUDINE | BRISTOL MYERS SQUIBB | Labeling Revision | 12/11/2008 |
|
ACTOS (NDA # 021073) |
034 | PIOGLITAZONE HYDROCHLORIDE | TAKEDA PHARMS NA | Labeling Revision | 12/11/2008 |
|
EPIDUO (NDA # 022320) |
000 | ADAPALENE; BENZOYL PEROXIDE | GALDERMA LABS LP | Approval | 12/11/2008 |
|
CIPROFLOXACIN HYDROCHLORIDE (ANDA # 076555) |
000 | CIPROFLOXACIN HYDROCHLORIDE | AKORN INC | Approval | 12/11/2008 |
|
CALCITONIN SALMON (ANDA # 076979) |
000 | CALCITONIN SALMON | NASTECH PHARMA | Tentative Approval | 12/11/2008 |