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U.S. Department of Health and Human Services

Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Exclusivity Codes

This page defines the exclusivity codes.

Displaying records 201 to 400 of 1012 Download data Download data       Previous Page  |  Next Page
Exclusivity Code Definition
I - 53 TREATMENT OF PANIC DISORDER, WITH OR WITHOUT AGORAPHOBIA
I - 54 RENAL CONCENTRATION CAPACITY TEST
I - 55 HYPERTENSION
I - 56 EROSIVE GASTROESOPHAGEAL REFLUX DISEASE
I - 57 SHORT-TERM TREATMENT OF ACTIVE DUODENAL ULCER
I - 58 INITIAL TREATMENT OF ADVANCED OVARIAN CARCINOMA IN COMBINATION WITH OTHER APPROVED CHEMOTHERAPEUTIC AGENTS
I - 59 ENDOSCOPICALLY DIAGNOSED ESOPHAGITIS, INCLUDING EROSIVE AND ULCERATIVE ESOPHAGITIS, AND ASSOCIATED HEARTBURN DUE TO GASTROESOPHAGEAL REFLUX DISEASE
I - 60 SINGLE APPLICATION TREATMENT OF HEAD LICE IN CHILDREN TWO MONTHS TO TWO YEARS IN AGE
I - 61 FEMALE ANDROGENETIC ALOPECIA
I - 62 PREVENTION AND TREATMENT OF POSTMENOPAUSAL OSTEOPOROSIS
I - 63 ONCE DAILY TREATMENT AS INITIAL THERAPY IN THE TREATMENT OF HYPERTENSION
I - 64 PREVENTION OF SUPRAVENTRICULAR TACHYCARDIAS
I - 65 PREVENTION OF UPPER GASTROINTESTINAL BLEEDING IN CRITICALLY ILL PATIENTS
I - 66 UNCOMPLICATED GONORRHEA
I - 67 TREATMENT OF ACUTE ASTHMATIC ATTACKS IN CHILDREN SIX YEARS OF AGE AND OLDER
I - 68 CENTRAL PRECOCIOUS PUBERTY
I - 69 SHORT TERM TREATMENT OF PATIENTS WITH SYMPTOMS OF GASTROESOPHAGEAL REFLUX DISEASE (GERD), AND FOR THE SHORT TERM TREATMENT OF ESOPHAGITIS DUE TO GERD INCLUDING ULCERATIVE DISEASE DIAGNOSED BY ENDOSCOPY
I - 70 USE IN COMBINATION WITH 5-FLUOROURACIL TO PROLONG SURVIVAL IN THE PALLIATIVE TREATMENT OF PATIENTS WITH ADVANCED COLORECTAL CANCER
I - 71 VARICELLA INFECTIONS (CHICKENPOX)
I - 72 PREVENTION OF CMV DISEASE IN TRANSPLANT PATIENTS AT RISK FOR CMV DISEASE
I - 73 INITIATE AND MAINTAIN MONITORED ANESTHESIA CARE (MAC) SEDATION DURING DIAGNOSTIC PROCEDURES
I - 74 INTRAVENOUS DIGITAL SUBTRACTION ANGIOGRAPHY
I - 75 TREATMENT OF ENDOSCOPICALLY DIAGNOSED EROSIVE ESOPHAGITIS
I - 76 PREVENTION OF OSTEOPOROSIS
I - 77 DERMAL INFECTIONS-TINEA PEDIS, TINEA CORPORIS, TINEA CRURIS DUE TO EPIDERMOPHYTON FLOCCOSUM
I - 78 CONTRAST ENHANCED COMPUTED TOMOGRAPHIC IMAGING OF THE HEAD AND BODY AND INTRAVENOUS EXCRETORY UROGRAPHY
I - 79 MANAGEMENT OF CHRONIC STABLE ANGINA AND ANGINA DUE TO CORONARY ARTERY SPASM
I - 80 DIAGNOSIS AND LOCALIZATION OF ISCHEMIA AND CORONARY HEART DISEASE
I - 81 PROPHYLAXIS IN DESIGNATED IMMUNOCOMPROMISED CONDITIONS TO REDUCE THE INCIDENCE OF OROPHARYNGEAL CANDIDIASIS
I - 82 TREATMENT OF TRAVELERS' DIARRHEA
I - 83 ANGIOCARDIOGRAPHY, CONTRAST ENHANCED COMPUTED TOMOGRAPHIC IMAGING OF THE HEAD AND BODY, AND INTRAVENOUS EXCRETORY UROGRAPHY IN CHILDREN
I - 84 INTRAOPERATIVE AND POSTOPERATIVE TACHYCARDIA AND/OR HYPERTENSION
I - 85 TREATMENT OF ANOREXIA ASSOCIATED WITH WEIGHT LOSS IN PATIENTS WITH AIDS
I - 86 TREATMENT OF SECONDARY CARNITINE DEFICIENCY
I - 87 RENAL IMAGING AGENT FOR USE IN CHILDREN
I - 88 MANAGEMENT OF ENDOMETRIOSIS
I - 89 EPIDURAL USE IN LABOR AND DELIVERY AS AN ANALGESIC ADJUNCT TO BUPIVACAINE
I - 90 INTENSIVE CARE UNIT SEDATION
I - 91 MONOTHERAPY USE FOR HYPERTENSION
I - 92 ADJUNCTIVE THERAPY IN THE MANAGEMENT OF HEART FAILURE
I - 93 PREVENTION OF EXERCISE-INDUCED BRONCHOSPASM IN CHILDREN AGES 4-11 YEARS
I - 94 USE WITH MRI IN ADULTS TO PROVIDE CONTRAST ENHANCEMENT AND FACILITATE VISUALIZATION OF LESIONS IN THE BODY [EXCLUDING THE HEART]
I - 95 TREATMENT OF LEFT VENTRICULAR DYSFUNCTION FOLLOWING MYOCARDIAL INFARCTION
I - 96 TREATMENT OF SYMPTOMATIC BENIGN PROSTATIC HYPERPLASIA
I - 97 ORAL OR RECTAL USE IN CHILDREN FOR THE EXAMINATION OF THE GASTROINTESTINAL TRACT
I - 98 TREATMENT OF CHILDREN WHO HAVE GROWTH FAILURE ASSOCIATED WITH CHRONIC RENAL INSUFFICIENCY
I - 99 PEDIATRIC ANESTHESIA IN CHILDREN 3 YEARS AND OLDER
I - 100 TO DECREASE THE INCIDENCE OF CANDIDIASIS IN PATIENTS UNDERGOING BONE MARROW TRANSPLANTATION WHO RECEIVE CYTOTOXIC CHEMOTHERAPY AND/OR RADIATION THERAPY
I - 101 TREATMENT OF DIABETIC NEPHROPATHY IN PATIENTS WITH TYPE I INSULIN-DEPENDENT DIABETES MELLITUS AND RETINOPATHY
I - 102 TREATMENT OF OBSESSIVE-COMPULSIVE DISORDER
I - 103 PROPHYLAXIS AGAINST PNEUMOCYSTIS CARINII PNEUMONIA IN INDIVIDUALS WHO ARE IMMUNOCOMPROMISED AND CONSIDERED TO BE AT RISK OF DEVELOPING PNEUMOCYSTIS CARINII PNEUMONIA
I - 104 TREATMENT OF PULMONARY AND EXTRAPULMONARY ASPERGILLOSIS IN PATENTS WHO ARE INTOLERANT OF OR WHO ARE REFRACTORY TO AMPHOTERICIN B THERAPY
I - 105 TREATMENT OF METASTATIC CARCINOMA OF THE BREAST AFTER FAILURE OF FIRST-LINE OR SUBSEQUENT CHEMOTHERAPY
I - 106 TREATMENT OF ACROMEGALY
I - 107 VAGINAL CANDIDIASIS
I - 108 EXPANDED USE-FOR ICU PATIENTS UNDERGOING LONG-TERM INFUSION DURING MECHANICAL VENTILATION
I - 109 TYPHOID FEVER
I - 110 PREVENTION OF NAUSEA AND VOMITING ASSOCIATED WITH RADIOTHERAPY
I - 111 TREATMENT OF PAGET'S DISEASE OF BONE
I - 112 MANAGEMENT OF MODERATE TO SEVERE PAIN
I - 113 TREATMENT OF PROSTATITIS
I - 114 USE IN CHILDREN TO VISUALIZE LESIONS WITH ABNORMAL VASCULARITY IN THE BRAIN (INTRACRANIAL LESIONS), SPINE, AND ASSOCIATED TISSUE
I - 115 USE IN MRI IN ADULTS TO VISUALIZE LESIONS IN THE HEAD AND NECK
I - 116 MAINTENANCE OF HEALING OF EROSIVE ESOPHAGITIS
I - 117 TO SLOW THE PROGRESSION FO CORONANY ATHEROSCLEROSIS IN PATIENTS WITH CORONARY HEART DISEASE
I - 118 PREVENTION OF DEEP VEIN THROMBOSIS, WHICH MAY LEAD TO PULMONARY EMBOLISM FOLLOWING KNEE REPLACEMENT SURGERY
I - 119 TREATMENT OF ANEMIA CAUSED BY UTERINE LEIOMYOMATA IN WOMEN WHO FAIL IRON THERAPY
I - 120 MAINTENANCE THERAPY FOR GASTRIC ULCER PATIENTS AT REDUCED DOSAGE AFTER HEALING ACUTE ULCERS
I - 121 EXPANDED PATIENT POPULATION -- USE IN ICU PATIENTS
I - 122 PSORIASIS OF THE SCALP
I - 123 RELIEF OF MILD TO MODERATE PAIN IN PATIENTS AGED 6 MONTHS AND OLDER
I - 124 LEUCOCYTE LABELED SCINTIGRAPHY AS AN ADJUNCT IN THE LOCALIZATION OF INTRA-ABDOMINAL INFECTION AND INFLAMMATORY BOWEL DISEASE
I - 125 EXPANSION OF CONSCIOUS SEDATION INDICATION TO INCLUDE SHORT THERAPEUTIC PROCEDURES
I - 126 ADJUNCT TO THALLIUM- 201 MYOCARDIAL PERFUSION IN PATIENTS UNABLE TO EXERCISE ADEQUATELY
I - 127 TREATMENT OF ACYCLOVIR-RESISTANT HERPES IN IMMUNOCOMPROMISED PATIENTS
I - 128 IN PT W/ CH DISEASE AND HYPERCHOLESTEROLEMIA: REDUCE RISK TOTAL MORTALITY BY REDUCING CORONARY DEATH; REDUCE RISK NON-FATAL MI; REDUCE RISK UNDERGOING MYOCARDIAL REVASCULARIZATION PROCEDURES; REDUCTION ELEVATED TOTAL AND LDL CHOL LEVELS...
I - 129 TREATMENT OF ALCOHOL DEPENDENCE
I - 130 MAINTENANCE OF HEALING OF EROSIVE ESOPHAGITIS
I - 131 PERIPHERAL ARTERIOGRAPHY
I - 132 TREATMENT OF MANIC PHASE OF BIPOLAR DISORDER
I - 133 MANAGEMENT OF CHRONIC STABLE ANGINA
I - 134 HEART FAILURE POST MYOCARDIAL INFARCTION
I - 135 BONE METASTASES ASSOCIATED WITH MULTIPLE MYELOMA
I - 136 IDIOPATHIC CHRONIC URTICARIA
I - 137 PREVENTION OF METAL-INDUCED HEART BURN, ACID INDIGESTION, AND SOUR STOMACH WHEN TAKEN 30 MINUTES PRIOR TO CONSUMING FOOD OR BEVERAGES
I - 138 TREATMENT OF ACUTE RECURRENT GENITAL HERPES
I - 139 PALLIATIVE TREATMENT OF ADVANCED BREAST CANCER IN PRE- AND PERIMENOPAUSAL WOMEN
I - 140 PREVENTION OF CYTOMEGALOVIRUS (CMV) DISEASE IN INDIVIDUALS WITH HIV INFECTION AT RISK FOR DEVELOPING CMV DISEASE
I - 141 TREATMENT OF HEMODYNAMICALLY STABLE PATIENTS WITHIN 24 HOURS OF ACUTE MYOCARDIAL INFARCTION TO IMPROVE SURVIVAL
I - 142 LOCALIZE MYOCARDIAL ISCHEMIA(REVERSIBLE DEFECT) AND INFARCTION (NON-REVERSIBLE DEFECTS) IN EVALUATING MYOCARDIAL FUNCTION
I - 143 EPISODIC TREATMENT OF RECURRENT GENITAL HERPES IN IMMUNOCOMPETENT ADULTS
I - 144 ENHANCEMENT OF MRI OF THE ADULT BODY INTERNAL ORGANS
I - 145 0.1MMOL/KG AS A SINGLE INTRAVEOUS BOLUS FOR MRI OF THE CNS IN CHILDREN
I - 146 CONTRAST ENHANCEMENT AND FACILITATION OF VISUALIZATION OF EXTRACRANIAL HEAD AND NECK LESIONS
I - 147 PREVENTION OF GALLSTONE FORMATION IN OBESE PATIENTS EXPERIENCING RAPID WEIGHT LOSS
I - 148 TREATMENT OF ACUTE PNEUMOCYSTIC CARINI PNEUMONIA (PCP) IN HIV-INFECTED PATIENTS WHOSE ALVEOLAR-ARTERIAL OXYGEN DIFFERENCE (AaDO2) IS LESS THAN OR EQUAL TO 55 TORR
I - 149 TREATMENT OF PATIENTS WITH NON-SMALL CELL LUNG CANCER
I - 150 TREATMENT OF OBSESSIVE COMPULSIVE DISORDER AND PANIC DISORDER
I - 151 PREVENTION OF AND PREVENTION OF FURTHER POSTOPERATIVE NAUSEA AND VOMITING IN PEDIATRIC PATIENTS RECEIVING GENERAL ANESTHESIA
I - 152 SLOWING THE PROGRESSION OF CORONARY ATHEROSCLEROSIS AND REDUCING THE RISK OF ACUTE CORONARY EVENTS
I - 153 MANAGEMENT OF SEVERE SPASTICITY [ENCOMPASES SPINAL AND CEREBRAL ORIGIN]
I - 154 PATIENT POPULATION ALTERED TO INCLUDE PEDIATRIC USE
I - 155 TREATMENT OF ONCHOMYCOSIS DUE TO DERMATOPHYTES (TINEA UNGUIUM) OF THE TOENAIL WITH OR WITHOUT FINGERNAIL INVOLVEMENT
I - 156 ADDITIONAL DATA REGARDING THE SAFE USE OF NORVASC IN PATIENTS WITH HEART FAILURE
I - 157 TREATMENT OF ACUTE UNCOMPLICATED CYSTITIS IN FEMALES
I - 158 TREATMENT OF OSTEOLYTIC BONE METASTASES OF BREAST CANCER
I - 159 FOR HYPERCHOLESTEROLEMIC PATIENTS WITHOUT CLINICALLY EVIDENT HEART DISEASE REDUCE THE RISK OF MYOCARDIAL INFARCTION, REVASCULARIZATION, AND DEATH DUE TO CARDIOVASCULAR CAUSES WITH NO INCREASE IN DEATH FROM NON-CARDIOVASCULAR CAUSES
I - 160 TREATMENT OF BACTERIAL CORNEAL ULCERS
I - 161 TREATMENT OF ADULT-ONSET OR CHILDHOOD-ONSET ADULT GROWTH HORMONE DEFICIENCY
I - 162 FOR USE IN PATIENTS 6-11 YEARS OF AGE
I - 163 TREATMENT OF PHOTOPHOBIA
I - 164 CHRONIC BACTERIAL PROSTATITIS
I - 165 MANAGEMENT OF ADULTS WITH ACTIVE, CLASSIC AND DEFINITIVE RHEUMATOID ARTHRITIS WHO HAVE HAD INSUFFICIENT THERAPEUTIC RESPONSE TO OR ARE INTOLERANT OF AN ADEQUATE TRIAL OF FULL DOSES OF ONE OR MORE NON-STEROIDAL ANTI-INFLAMMATORY DRUGS
I - 166 TREATMENT OF BULIMIA
I - 167 COMPLICATED INTRA-ABDOMINAL INFECTIONS (USED IN COMBINATION WITH METRONIDAZOLE) CAUSED BY MIXED AEROBIC/ANAEROBIC PATHOGENS
I - 168 MANAGEMENT OF LOCALLY CONFINED STAGE B2-C METASTATIC CARCINOMA OF THE PROSTATE (IN COMBINATION WITH LHRH AGONISTS)
I - 169 USE IN COMBINATION WITH CORTICOSTEROIDS AS INITIAL CHEMOTHERAPY FOR THE TREATMENT OF PATIENTS WITH PAIN RELATED TO ADVANCED HORMONE-REFRACTORY PROSTATE CANCER
I - 170 PROPHYLACTIC USE DURING HEAD LICE EPIDEMICS
I - 171 RELIEF OF SYMPTOMS OF THE COMMON COLD
I - 172 TREATMENT OF INITIAL EPISODE OF GENITAL HERPES
I - 173 PREOPERATIVELY FOR THE PREVENTION OF INFECTION IN TRANSRECTAL PROSTATE BIOPSY
I - 174 PELVIC INFLAMMATORY DISEASE
I - 175 TREATMENT OF TINEA CORPORIS AND TINEA CRURIS
I - 176 TREATMENT OF POSTOPERATIVE INFLAMMATION IN PATIENTS WHO HAVE UNDERGONE CATARACT EXTRACTION
I - 177 TX OF MODERATE ACNE VULGARIS IN FEMALES,GREATER OR EQUAL TO 15YRS OF AGE,WHO HAVE NO KNOWN CONTRAINDICATIONS TO ORAL CONTRACEPTIVE THERAPY,DESIRE CONTRACEPTION,HAVE ACHIEVED MENARCHE AND ARE UNRESPONSIVE TO TOPICAL ANTI-ACNE MEDICATIONS
I - 178 TREATMENT OF ONCHOMYCOSIS OF THE FINGERNAIL WITHOUT CONCOMITANT ONCHOMYCOSIS OF THE TOENAIL WITH A PULSE DOSING REGIMEN
I - 179 NOSOCOMIAL PNEUMONIA-MILD TO MODERATE AND SEVERE CAUSED BY HAEMOPHILUS INFLUENZAE OR KLEBSIELLA PNEUMONIAE
I - 180 TREATMENT OF PLANTAR TINEA PEDIS (MOCCASIN TYPE)
I - 181 TREATMENT OF PATIENTS WITH COMPLEX PARTIAL SEIZURES WITH AND WITHOUT SECONDARY GENERALIZATION
I - 182 TREATMENT OF GROWTH FAILURE ASSOCIATED WITH TURNER SYNDROME
I - 183 MAINTENANCE THERAPY IN THE MANAGEMENT OF MILD TO MODERATE ASTHMA IN PEDIATRIC PATIENTS AGES 6-11
I - 184 TREATMENT OF PANIC DISORDER AT A RECOMMENDED DOSE RANGE OF 1 TO 2MG/DAY (MAXIMUM OF 4MG)
I - 185 PREVENTION OF OSTEOPOROSIS IN POSTMENOPAUSAL WOMEN
I - 186 TREATMENT OF TINEA (PITYRIASIS) VERSICOLOR CAUSED BY OR PRESUMED TO BE CAUSED BY PITYROSPORUM ORBICULARE (ALSO KNOWN AS MALASSEZIA FURFUR OR M. ORBICULARE)
I - 187 PREVENTION OF FRACTURES IN THE TREATMENT OF POSTMENOPAUSAL OSTEOPOROSIS
I - 188 TREATMENT OF ACUTE SINUSITIS AND ACUTE EXACERBATION OF CHRONIC SINUSITIS
I - 189 TREATMENT OF ACUTE OTITIS MEDIA IN PEDIATRIC PATIENTS
I - 190 PLANAR IMAGING AS A SECOND LINE DIAGNOSTIC DRUG AFTER MAMMOGRAPHY TO ASSIST IN THE EVALUATION OF BREAST LESIONS IN PATIENTS WITH AN ABNORMAL MAMMOGRAM OR A PALPABLE BREAST MASS
I - 191 ENDOMETRIAL THINNING AGENT PRIOR TO ENDOMETRIAL ABLATION FOR DYSFUNCTIONAL UTERINE BLEEDING
I - 192 THE PREVENTION OF DEEP VEIN THROMBOSIS, WHICH MAY LEAD TO PULMONARY EMBOLISM, IN PATIENTS UNDERGOING ABDOMINAL SURGERY WHO ARE AT RISK FOR THROMBOEMBOLIC COMPLICATIONS AND A NEW DOSAGE REGIMEN, 40MG ONCE DAILY, FOR THIS INDICATION
I - 193 TREATMENT OF PANIC DISORDER IN A RECOMMENDED DOSE RANGE OF 50 TO 200MG/DAY
I - 194 CONGESTIVE HEART FAILURE
I - 195 FOR USE OF LANSOPRAZOLE IN COMBINATION WITH CLARITHROMYCIN AND AMOXICILLIN FOR THE ERADICATION OF HELICOBACTER PYLORI IN PATIENTS WITH ACTIVE DUODENAL ULCER DISEASE OR A ONE-YEAR HISTORY OF DUODENAL ULCER
I - 196 ACUTE TREATMENT OF ACTIVE BENIGN GASTRIC ULCER
I - 197 MAINTENANCE OF HEALING OF DUODENAL ULCER
I - 198 FOR THE USE OF LANSOPRAZOLE IN COMBINATION WITH AMOXICILLIN FOR THE ERADICATION OF HELICOBACTER PYLORI IN PATIENTS WITH ACTIVE DUODENAL ULCER DISEASE OR A ONE-YEAR HISTORY OF A DUODENAL ULCER
I - 199 MONOTHERAPY AND COMBINATION THERAPY WITH SULFONYL UREAS IN THE TREATMENT OF TYPE II DIABETES
I - 200 TREATMENT OF TINEA (PITYRIASIS) VERSICOLOR
I - 201 EMPIRICAL THERAPY FOR FEBRILE NEUTROPENIC PATIENTS
I - 202 SECOND-LINE TREAMENT OF AIDS-RELATED KAPOSI'S SARCOMA
I - 203 MAINTENANCE OF REMISSION OF ULCERATIVE COLITIS
I - 204 USE IN PEDIATRIC PATIENTS BETWEEN THE AGES OF 6 AND 11 FOR THE TREATMENT OF THE NASAL SYMPTOMS OF SEASONAL AND PERENNIAL ALLERGIC RHINITIS
I - 205 INITIAL ANTICONVULSANT TREATMENT OF STATUS EPILEPTICUS
I - 206 TREATMENT OF EDEMA ASSOCIATED WITH CHRONIC RENAL FAILURE
I - 207 FOR THE SUPPRESSION OF RECURRENT EPISODES OF GENITAL HERPES IN IMMUNOCOMPETENT ADULTS
I - 208 TREATMENT OF OBSESSIVE COMPULSIVE DISORDER IN THE PEDIATRIC POPULATION
I - 209 PAROXYSMAL SUPRAVENTRICULAR TACHYCARDIA (PSVT)
I - 210 TO SLOW THE PROGRESSION OF CORONARY ATHEROSCLEROSIS IN PATIENTS WITH CORONARY HEART DISEASE AS PART OF A TREATMENT STRATEGY TO LOWER TOTAL AND LDL CHOLESTEROL TO TARGET LEVELS
I - 211 FOR USE IN PEDIATRIC POPULATION
I - 212 TREATMENT OF SYMPTOMS OF DRY MOUTH IN PATIENTS WITH SJOGREN'S SYNDROME
I - 213 TEMPORARY RELIEF OF PAIN AND PHOTOPHOBIA IN PATIENTS UNDERGOING CORNEAL REFRACTIVE SURGERY
I - 214 TREATMENT OF OSTEOPOROSIS
I - 215 PRE-PROCEDURAL APPLICATION TO ADULT MALE GENITAL SKIN PRIOR TO SITE-SPECIFIC SUBCUTANEOUS INFILTRATION WITH LIDOCAINE FOR THE REMOVAL OF GENITAL WARTS
I - 216 FOR THE LONG-TERM TWICE-DAILY (MORNING AND EVENING) ADMINISTRATION IN THE MAINTENANCE TREATMENT OF BRONCHOSPASM ASSOCIATED WITH COPD, INCLUDING CHRONIC BRONCHITIS AND EMPHYSEMA
I - 217 PREVENTION (DURING AND FOLLOWING HOSPITALIZATION) OF DEEP VEIN THROMBOSIS, WHICH MAY LEAD TO PULMONARY EMBOLISM, IN PATIENTS UNDERGOING HIP REPLACEMENT SURGERY
I - 218 USE OF LIPITOR AS AN ADJUNCTIVE THERAPY TO DIET FOR THE TREATMENT OF PATIENTS WITH ELEVATED SERUM TRIGLYCERIDE LEVELS (FREDERICKSON TYPE IV)
I - 219 USE OF LIPITOR BY PATIENTS WITH PRIMARY DYSBETALIPOPROTEINEMIA (FREDERICKSON TYPE III) WHO DO NOT RESPOND ADEQUATELY TO DIET
I - 220 TREATMENT OF EPISODIC- HEARTBURN, ACID INDIGESTION AND SOUR STOMACH
I - 221 TREATMENT OF BENIGN PROSTATIC HYPERPLASIA (BPH) IN MEN WITH AN ENLARGED PROSTATE TO IMPROVE SYMPTOMS, REDUCE THE RISK OF ACUTE URINARY RETENTION AND REDUCE THE RISK OF THE NEED OF SURGERY
I - 222 PREVENTION OF ISCHEMIC COMPLICATIONS OF UNSTABLE ANGINA AND NON-Q-WAVE MYOCARDIAL INFARCTION, WHEN CONCURRENTLY ADMINISTERED WITH ASPIRIN
I - 223 USE IN THE SYMPTOMATIC RELIEF OF RHINORRHEA ASSOCIATED WITH ALLERGIC AND NONALLERGIC-PERENNIAL RHINITIS IN CHILDREN AGE 6-11 YEARS
I - 224 FOR THE USE IN PEDIATRIC PATIENTS 4 TO 11 YEARS OF AGE FOR THE MANAGEMENT OF THE NASAL SYMPTOMS OF SEASONAL AND PERENNIAL ALLERGIC RHINITIS
I - 225 USE IN PATIENTS WITH PREVIOUS MI AND NORMAL CHOLESTEROL LEVELS, TO REDUCE RISK OF RECURRENT MI, MYOCARDIAL REVASCULARIZATION, AND CEREBROVASCULAR DISEASE EVENTS
I - 226 FIRST-LINE THERAPY FOR THE TREATMENT OF ADVANCED CARCINOMA OF THE OVARY IN COMBINATION WITH CISPLATIN
I - 227 SHORT-TERM TREATMENT OF SYMPTOMATIC GASTROESPHAGEAL REFLUX DISEASE (GERD)
I - 228 PREVENTION OF MEAL INDUCED HEARTBURN AT A DOSE OF 75MG TAKEN 30-60MIN PRIOR TO A MEAL
I - 229 PRILOSEC (OMEPRAZOLE), AMOXICILLIN, AND CLARITHROMYCIN FOR THE ERADICATION OF H. PYLORI IN PATIENTS WITH DUODENAL ULCER DISEASE
I - 230 IN COMBINATION WITH CIS-PLATIN, FOR THE FIRST LINE TREATMENT OF NON-SMALL CELL LUNG CANCER IN PATIENTS WHO ARE NOT CANDIDATES FOR POTENTIALLY CURATIVE SURGERY AND/OR RADIATION
I - 231 TREATMENT OF PATIENTS WITH LOCALLY ADVANCED OR METASTATIC BREAST CANCER AFTER FAILURE OF PRIOR CHEMOTHERAPY
I - 232 TREATMENT OF RECURRENT MUCOCUTANEOUS HERPES SIMPLEX INFECTIONS IN HIV-AFFECTED PATIENTS AT A DOSE OF 500MG TWICE DAILY
I - 233 PROPHYLACTIC USE TO REDUCE PERIOPERATIVE BLOOD LOSS AND THE NEED FOR BLOOD TRANSUFSION IN PATIENTS UNDERGOING CARDIOPULMONARY BYPASS IN THE COURSE OF CORONARY ARTERY BYPASS GRAFT SURGERY
I - 234 FOR USE IN COMBINATION WITH CISPLATIN FOR THE FIRST-LINE TREATMENT OF PATIENTS WITH INOPERABLE LOCALLY ADVANCED (STAGE IIIA OR IIIB) OR METASTATIC (STAGE IV) NON-SMALL CELL LUNG CANCER
I - 235 PREVENTION OF EXERCISE-INDUCED BRONCHOSPASM IN PATIENTS 12 YEARS OF AGE AND OLDER
I - 236 PREVENTION OF EXERCISE-INDUCED BRONCHOSPASM IN PATIENTS 4 YEARS OF AGE AND OLDER
I - 237 MAINTENANCE TREATMENT OF ASTHMA AND PREVENTION OF BRONCHOSPASM IN PATIENTS 4 YEARS OF AGE AND OLDER
I - 238 ADJUNCTIVE TREATMENT OF LENNOX-GASTAUT SYNDROME IN PEDIATRIC AND ADULT PATIENTS
I - 239 TREATMENT OF PATIENTS WITH HOMOZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA
I - 240 MANAGEMENT OF SECONDARY HYPERPARATHYROIDISM AND RESULTANT METABOLIC BONE DISEASE IN PATIENTS WITH MODERATE TO SEVERE CHRONIC RENAL FAILURE (CCR 15 TO 55ML/MIN) NOT YET ON DIALYSIS
I - 241 USE IN PHOTODYNAMIC THERAPY (PDT) FOR REDUCTION OF OBSTRUCTION AND PALLIATION OF SYMPTOMS IN PATIENTS WITH COMPLETELY OR PARTIALLY OBSTRUCTING ENDOBRONCHIAL NONSMALL CELL LUNG CANCER
I - 242 TREATMENT OF MODERATE TO SEVERE VASOMOTOR SYMPTOMS ASSOCIATED WITH THE MENOPAUSE AND IN THE TREATMENT OF VULVAR AND VAGINAL ATROPHY IN WOMEN WITH AN INTACT UTERUS
I - 243 USE IN THE SYMPTOMATIC RELIEF OF RHINORRHEA ASSOCIATED WITH THE COMMON COLD IN CHILDREN AGE 5 TO 11 YEARS
I - 244 REDUCE THE INCIDENCE OF BREAST CANCER IN WOMEN AT HIGH RISK FOR BREAST CANCER
I - 245 TREATMENT OF ACUTE SINUSITIS
I - 246 TREATMENT OF UNCOMPLICATED URINARY TRACT INFECTIONS
I - 247 USE IN CONVERSION TO MONOTHERAPY IN ADULTS WITH PARTIAL SEIZURES WHO ARE RECEIVING TREATMENT WITH A SINGLE ENZYME-INDUCING ANTIEPILEPTIC DRUG
I - 248 INPATIENT TREATMENT OF ACUTE DEEP VEIN THROMBOSIS WITH/WITHOUT PULMONARY EMBOLISM WHEN ADMIN WITH WARFARIN SODIM AND OUTPATIENT TREATMENT OF ACUTE DEEP VEIN THROMBOSIS WITHOUT PULMONARY EMBOLISM WHEN ADMIN WITH WARFARIN SODIUM
I - 249 TREATMENT OF CHRONIC HEPATITIS C IN PATIENTS WITH COMPENSATED LIVER DISEASE PREVIOUSLY UNTREATED WITH ALPHA INTERFERON THERAPY
I - 250 PRIMARY PREVENTION OF CORONARY HEART DISEASE IN PATIENTS WITHOUT SYMPATOMATIC CARDIOVASCULAR DISEASE WHO HAVE AVERAGE TO MODERATELY ELEVATED TOTAL-C AND LDL-C AND BELOW AVERAGE HDL-C
I - 251 TREATMENT OF GENERALIZED ANXIETY DISORDER
I - 252 NEW COMBINATION USE OF PRECOSE FOR PATIENTS WITH TYPE 2 DIABETES TREATED WITH DIET PLUS METFORMIN

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FDA/Center for Drug Evaluation and Research
Office of Generic Drugs
Division of Labeling and Program Support
Update Frequency:

Orange Book Data - Monthly
Generic Drug Product Information & Patent Information - Daily
Orange Book Data Updated Through November 2014
Patent and Generic Drug Product Data Last Updated December 17, 2014

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