loader
Please Wait
Applying Filters...

Setid F7deaf21 A14a 4f9d A576 Ece333219482 Applno 18276 Form Tablet Oral Dosage 2mg - Drug Product Composition: Alprazolamum [INN-Latin]

Menu
Xls

USFDA APPLICATION NUMBER - 18276 / DOSAGE - TABLET;ORAL - 2MG

Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ALPRAZOLAM(UNII: YU55MQ3IZY)
(ALPRAZOLAM - UNII:YU55MQ3IZY)
ALPRAZOLAM2mg

Inactive Ingredients

Ingredient Name
ANI Pharmaceuticals, Inc.
PD-Rx Pharmaceuticals, Inc.
A-S Medication Solutions
A-S Medication Solutions LLC
Actavis Pharma, Inc.
American Health Packaging
Aphena Pharma Solutions - Tennessee, LLC
Apotex Corp.
Bionpharma Inc.
Bryant Ranch Prepack
Cardinal Health
Golden State Medical Supply Inc
KAISER FOUNDATION HOSPITALS
Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC
Lake Erie Medical DBA Quality Care Products LLC
McKesson Contract Packaging
Medsource Pharmaceuticals
NCS HealthCare of KY, Inc dba Vangard Labs
NCS HealthCare of KY, LLC dba Vangard Labs
NuCare Pharmaceuticals, Inc.
NuCare Pharmaceuticals,Inc.
Par Pharmaceutical
PD-Rx Pharmaceuticals, Inc.
Qualitest Pharmaceuticals
RedPharm Drug, Inc.
REMEDYREPACK INC.
Sun Pharma Global FZE
Boca Pharmacal, LLC
DirectRX
Mylan Institutional Inc.
Mylan Pharmaceuticals Inc.
Proficient Rx LP
Preferred Pharmaceuticals Inc.
Preferred Pharmaceuticals, Inc.
Unit Dose Services
Aurobindo Pharma Limited
Major Pharmaceuticals
Quality Care Products, LLC
Rising Pharmaceuticals, Inc.
RPK Pharmaceuticals, Inc.
Sandoz Inc
Uni
Risi
Rising Pharmaceutical
ANHYDROUS LACTOSE(3SY5LH9PMK)                                           
CELLULOSE, MICROCRYSTALLINE(OP1R32D61U)                 
COLLOIDAL SILICON DIOXIDE(ETJ7Z6XBU4)                                         
CORN(0N8672707O)                                         
CROSCARMELLOSE SODIUM(M28OL1HH48)                                   
CROSPOVIDONE (15 MPA.S AT 5%)(68401960MK)                                         
CROSPOVIDONE(2S7830E561)                                     
CROSPOVIDONE(68401960MK)                                          
CROSPOVIDONE, UNSPECIFIED(2S7830E561)                                         
D&C YELLOW NO. 10 ALUMINUM LAKE(CQ3XH3DET6)                                           
D&C YELLOW NO. 10(35SW5USQ3G)                              
DIETHYLHEXYL SODIUM SULFOSUCCINATE(F05Q2T2JA0)                                           
DOCUSATE SODIUM(F05Q2T2JA0)        
FD&C BLUE NO. 1(H3R47K3TBD)                                        
FD&C BLUE NO. 2 ALUMINUM LAKE(4AQJ3LG584)                                           
FD&C BLUE NO. 2(L06K8R7DQK)              
FD&C YELLOW NO. 6 ALUMINUM LAKE(GYP6Z2JR6Q)                                           
FD&C YELLOW NO. 6(H77VEI93A8)                
HYDROXYPROPYL CELLULOSE (1600000 WAMW)(RFW2ET671P)                                           
HYPROMELLOSE 2910 (3 MPA.S)(0VUT3PMY82)                                         
LACTOSE MONOHYDRATE(EWQ57Q8I5X)        
LACTOSE(J2B2A4N98G)                                        
LACTOSE, UNSPECIFIED FORM(J2B2A4N98G)                                
MAGNESIUM STEARATE(70097M6I30)       
MANNITOL(3OWL53L36A)                                           
MICROCRYSTALLINE CELLULOSE 101(7T9FYH5QMK)                                           
MICROCRYSTALLINE CELLULOSE(OP1R32D61U)                         
POVIDONE K30(U725QWY32X)                                 
POWDERED CELLULOSE(SMD1X3XO9M)                                        
SILICON DIOXIDE(ETJ7Z6XBU4)        
SODIUM BENZOATE(OJ245FE5EU)        
SODIUM LAURYL SULFATE(368GB5141J)                                  
SODIUM STARCH GLYCOLATE TYPE A CORN(AG9B65PV6B)                                           
SODIUM STARCH GLYCOLATE TYPE A POTATO(5856J3G2A2)                                     
STARCH, CORN(O8232NY3SJ)           
ZEA MAYS (CORN) STARCH(O8232NY3SJ)