|
Product |
Therapeutic category |
US-DMF |
CEP |
E-DMF |
|
Filed |
Approved |
Ready |
Filed |
|
Meropenem(Sterile Bulk) |
Anti-infective |
P |
|
P |
P |
|
Meropenem and Sodium carbonate (Sterile Bulk) |
Anti-infective |
P |
|
P |
P |
|
Imipenem(Sterile) |
Anti-infective |
P |
|
P |
P |
|
Cilastatin sodium
(sterile Bulk) |
Anti-infective |
P |
|
P |
P |
|
Imipenem and Cilastatin sodium for Injection (Sterile Bulk) |
Anti-infective |
P |
|
P |
P |
|
Alendronate sodium |
Bone resorption Inhibitor |
P |
P |
P |
|
|
Alfuzosin Hydrochloride |
Benign Prostate Hyperplasia |
P |
P |
|
P |
|
Amisulpiride |
Anti-Psychotic |
|
|
P |
|
|
Amlodipine Besylate |
Anti- Hypertensive |
P |
P |
|
P |
|
Amoxicillin Sodium Sterile |
Beta-Lactam antibiotic |
|
|
|
P |
|
Amoxicillin Trihydrate |
Anti-Infective |
P |
P |
|
P |
|
Ampicillin + Sulbactam |
Beta-Lactam antibiotic |
P |
|
P |
|
|
Ampicillin Sodium Sterile |
Anti-Infective |
P |
P |
|
P |
|
Ampicillin Trihydrate |
Anti-Infective |
P |
P |
P |
|
|
Ampicillin Trihydrate Sterile (VMF) |
Anti-Infective |
P |
|
P |
|
|
Aripiprazole |
Anti- Psychotic |
|
|
Q3-2010 |
|
|
Atazanavir |
HIV Infections |
|
|
Q4-2010 |
|
|
Atomoxetine Hydrochloride |
Anti- depressant |
P |
|
P |
|
|
Atorvastatin |
Lipid lowering agent |
|
|
Q3-2010 |
|
|
Balsalazide |
Anti Ulcerative |
|
|
Q2-2010 |
|
|
Benazepril Hydrochloride |
Anti- Hypertensive |
P |
P |
P |
|
|
Betahistine |
Histamine agonist |
|
|
Q4-2010 |
|
|
Bisoprolol Fumarate |
Beta Blocker-Anti Hypertensive |
P |
P |
P |
|
|
Bupropion Hydrochloride |
Anti- depressant |
P |
|
P |
|
|
Candesartan Cilexetil |
Anti- Hypertensive |
|
|
Q3-2010 |
|
|
Carvedilol Hcl |
Beta Blocker- Antihypertensive |
P |
P |
|
P |
|
Cefazolin sodium sterile |
Cephalosporin antibiotic |
P |
P |
|
P |
|
Cefdinir |
Cephalosporin antibiotic |
P |
|
P |
|
|
Cefepime for Inj |
Cephalosporin antibiotic |
P |
P |
|
P |
|
Cefixime Trihydrate |
Anti-Infective |
|
P |
|
P |
|
Cefotaxime Sodium Sterile |
Cephalosporin antibiotic |
P |
P |
|
P |
|
Cefoxitin Sodium Sterile |
Cephalosporin antibiotic |
P |
|
|
P |
|
Cefpodoxime Proxetil |
Cephalosporin antibiotic |
P |
|
|
P |
|
Cefprozil |
Cephalosporin antibiotic |
P |
|
|
P |
|
Ceftazidime Pentahydrate Sterile |
Cephalosporin antibiotic |
P |
P |
|
P |
|
Ceftiofur Hydrochloride |
Anti-bacterial (Veterinary) |
P |
|
|
P |
|
Ceftiofur Sodium Sterile (VMF) |
Anti-bacterial (Veterinary) |
P |
|
|
P |
|
Ceftriaxone Sodium Sterile |
Cephalosporin antibiotic |
P |
P |
P |
|
|
Cefuroxime Axetil |
Cephalosporin antibiotic |
P |
P |
|
P |
|
Cefuroxime Sodium Sterile |
Cephalosporin antibiotic |
P |
|
|
P |
|
Celecoxib |
Pain Management |
|
|
Q4-2010 |
|
|
Cephapirin Benzathine (VMF) |
Anti-Infective (Veterinary) |
P |
|
|
|
|
Citalopram Hbr |
Anti- depressant |
P |
|
|
P |
|
Clindamycin Hcl |
Amino gycoside antibiotic |
|
|
Q4-2010 |
|
|
Clindamycin Palmitate Hcl |
Amino gycoside antibiotic |
P |
|
P |
|
|
Clopidogrel Bisulfate |
Anti Thrombotic |
P |
|
|
P |
|
Cloxacillin Sodium |
Beta-Lactam antibiotic |
|
P |
P |
|
|
Darifenacin Hydrobromide |
Urinary Incontinence |
|
|
Q4-2010 |
|
|
Dicloxacillin Sodium |
Beta-Lactam antibiotic |
P |
|
|
P |
|
Domperidone Maleate |
Anti- Emetic |
|
P |
|
P |
|
Donepezil |
Alzheimer's Disease |
P |
|
|
P |
|
Doxazosin Mesylate |
BPH treatment |
P |
P |
P |
|
|
Duloxetine |
Anti-depressant |
P |
|
P |
|
|
Entacapone |
Parkinson's disease |
|
|
Q4-2010 |
|
|
Escitalopram oxalate |
Anti-depressant |
P |
|
|
P |
|
Esomeprazole Magnesium |
Anti- Ulcerant |
|
|
Q3-2010 |
|
|
Famciclovir |
Dermatological Infections |
P |
|
P |
|
|
Felodipine |
Anti- Hypertensive |
P |
P |
P |
|
|
Finasteride |
BPH treatment |
P |
P |
|
|
|
Florfenicol (VMF) |
Anti-bacterial (Veterinary) |
P |
|
|
P |
|
Flucloxacillin Sodium |
Beta Lactam antibiotic |
|
P |
P |
|
|
Flucloxacillin Sodium Sterile |
Beta Lactam antibiotic |
|
P |
P |
|
|
Fluconazole |
Gynecology |
P |
P |
|
P |
|
Fluvastatin Sodium |
Lipid lowering agent |
P |
P |
P |
|
|
Fosinopril Sodium |
Anti- Hypertensive |
P |
|
|
P |
|
Galantamine |
Alzheimer's Disease |
P |
|
P |
|
|
Ibandronate |
Bone resorption Inhibitor |
P |
|
P |
|
|
Irbesartan |
Anti- Hypertensive |
P |
|
|
P |
|
Lamivudine |
HIV Infections |
P |
|
Q2-2010 |
|
|
Lamotrigine |
Anti epileptic |
P |
P |
|
P |
|
Levetiracetam |
Anti epileptic |
P |
|
P |
|
|
Levofloxacin |
Quinolone antibiotic |
P |
|
P |
|
|