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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 1 to 200 of 984 Download data Download data       Previous Page  |  Next Page
Exclusivity Code Definition
D - 0 NEW DOSING SCHEDULE (SEE INDIVIDUAL REFERENCES)
D - 1 ONCE A DAY APPLICATION
D - 2 ONCE DAILY DOSING
D - 3 SEVEN DAYS/SEVEN DAYS/SEVEN DAYS DOSING SCHEDULE
D - 4 SEVEN DAYS/FOURTEEN DAYS DOSING SCHEDULE
D - 5 TEN DAYS/ELEVEN DAYS DOSING SCHEDULE
D - 6 SEVEN DAYS/NINE DAYS/FIVE DAYS DOSING SCHEDULE
D - 7 BID DOSING
D - 8 INTRAVENOUS, EPIDURAL AND INTRATHECAL DOSING
D - 9 NARCOTIC OVERDOSE IN ADULTS
D - 10 NARCOTIC OVERDOSE IN CHILDREN
D - 11 POSTOPERATIVE NARCOTIC DEPRESSION IN CHILDREN
D - 12 BEDTIME DOSING OF 800MG FOR TREATMENT OF ACTIVE DUODENAL ULCER
D - 13 INCREASED MAXIMUM DAILY DOSAGE RECOMMENDATION
D - 14 BEDTIME DOSING OF 800MG FOR TREATMENT OF ACTIVE BENIGN GASTRIC ULCER
D - 15 SINGLE DAILY DOSE OF 25MG/37.5MG
D - 16 CONTINUOUS INTRAVENOUS INFUSION
D - 17 400MG EVERY 12 HOURS FOR THREE DAYS FOR UNCOMPLICATED URINARY TRACT INFECTIONS
D - 18 LOWER RECOMMENDED STARTING DOSE GUIDELINES
D - 19 BOLUS DOSING GUIDELINES
D - 20 SINGLE 32MG DOSE
D - 21 ALTERNATIVE DOSAGE OF 300MG ONCE DAILY AFTER THE EVENING MEAL
D - 22 REDUCTION IN INFUSION TIME FROM 24 TO 4 HOURS FOR THE 60MG DOSE
D - 23 INCREASE MAXIMUM DOSE AND VARIATIONS IN THE DOSING REGIMEN
D - 24 FOR OVARIAN CANCER THE RECOMMENDED REGIMEN IS 135MG/M2 OR 175MG/M2 INTRAVENOUSLY OVER THREE HOURS EVERY THREE WEEKS
D - 25 ADDITIONAL DOSAGE REGIMEN EQUAL TO HALF THE ORIGINAL DOSING REGIMEN
D - 26 ONCE WEEKLY APPLICATION
D - 27 BID DOSING IN PATIENTS 12 YEARS OF AGE AND OLDER FOR PREVENTION OF NAUSEA AND VOMITING ASSOCIATED WITH MODERATE EMETOGENIC CANCER CHEMOTHERAPY
D - 28 USE OF ISOVUE-370 IN EXCRETORY UROGRAPHY AT EQUIVALENT GRAMS OF IODINE TO THE CURRENTLY APPROVED ISOVUE-250 AND ISOVUE-300
D - 29 INCREASE OF CUMULATIVE DOSE TO 0.3MMOL/KG FOR MRI OF CNS IN ADULTS
D - 30 5000 IU DOSE FOR PHOPHYLAXIX AGAINST DEEP VEIN THROMBOSIS
D - 31 CHANGE IN RECOMMENDED TOTAL DAILY DOSE TO 80MG (40MG BID)
D - 32 REMOVAL OF THE RESTRICTIONS LIMITING TREATMENT TO TWO CONSECUTIVE WEEKS AND TO SMALL AREAS
D - 33 ONCE DAILY DOSING FOR PLAQUE PSORIASIS
D - 34 EVERY FOUR MONTHS DOSAGE REGIMEN
D - 35 FOR A ONE WEEK DOSING OF INTERDIGITAL TINEA PEDIS
D - 36 FOR A SINGLE 2MG DOSE AS AN ALTERNATIVE TO THE 1MG DOSE GIVEN TWICE DAILY
D - 37 DOSING REGIMEN FOR ADMINISTRATION EITHER ONCE DAILY (QD) OR TWICE DAILY (BID)
D - 38 CONTINUOUS INFUSION AS AN ALTERNATE METHOD OF ADMINISTRATION
D - 39 CHANGE IN TIME TO TAKE THE DRUG PRIOR TO A MEAL TO PREVENT MEAL-INDUCED HEARTBURN SYMPTOMS FROM '..1/2 TO 1 HOUR BEFORE EATING' TO '.. RIGHT BEFORE EATING OR UP TO 60MIN BEFORE CONSUMING...'
D - 40 ONCE-A-DAY DOSING REGIMEN
D - 41 DRUG MAY BE DOSED RIGHT BEFORE A MEAL OR ANY TIME UP TO 30MIN BEFORE EATING OR DRINKING FOOD AND BEVERAGES THAT WOULD BE EXPECTED TO CAUSE SYMPTOMS
D - 42 TEN DAY DOSING REGIMEN FOR TRIPLE THERAPY, PREVACID IN COMBINATION WITH CLARITHROMYCIN AND AMOXICILLIN, FOR THE ERADICATION OF H.PYLORI IN PATIENTS WITH DUODENAL ULCER DISEASE
D - 43 INITIATION OF TREATMENT WITH 900MG/DAY BY DELETION OF THE REQUIREMENT TO TITRATE TO 900MG/DAY OVER A 3-DAY PERIOD
D - 44 IN A CLINICAL TRIAL, FEWER DISCONTINUATIONS DUE TO ADVERSE EVENTS, ESPECIALLY DIZZINESS AND VERTIGO, WERE OBSERVED WHEN TITRATING THE DOSE IN INCREMENTS OF 50MG/DAY EVERY 3 DAYS UNTIL AN EFFECTIVE DOSE (NOT EXCEEDING 400MG/DAY) WAS REACHED
D - 45 ONCE DAILY DOSING FOR MAINTENANCE ONLY
D - 46 NEW DOSING REGIMEN OF 80MG DAILY
D - 47 PREVENTION OF HEARTBURN SYMPTOMS WHEN ADMINISTERED FROM 15 MINUTES UP TO, BUT NOT INCLUDING, 1 HOUR PRIOR TO A PROVOCATIVE MEAL
D - 48 ADIMISTRATION OF CISATRICURIUM A NEUROMUSCULAR BLOCKING AGENT AT DOSES OF 3 AND 4X THE ED95 OF CISATRICURIUM FOLLOWING INDUCTION WITH THIOPENTAL
D - 49 PEDIATRIC DOSING GUIDELINES
D - 50 INFORMATION FOR USE OF CORVERT IN POST-CARDIAC SURGERY PATIENTS
D - 51 OPTIONAL STARTING DOSE OF 40MG/DAY
D - 52 ALTERNATE DOSING REGIMEN OF 1250MG TWICE DAILY
D - 53 USE IN PEDIATRIC PATIENTS FROM 1 MONTH TO 16 YEARS OF AGE
D - 54 USE OF ZYBAN FOR MAINTENANCE THERAPY. TREATMENT UP TO 6 MONTHS WAS SHOWN EFFICACIOUS
D - 55 ADDITION OF A HIGHER DOSE OF NUTROPIN FOR PUBERTAL PATIENTS (PUBERTAL DOSE LESS THAN OR EQUAL TO 0.7MG/KG/WEEK)
D - 56 ADDITION OF POSTPRANDIAL DOSING
D - 57 3-HOUR INFUSION OF TAXOL GIVEN EVERY THREE WEEKS AT A DOSE OF 175MG/M2 FOLLOWED BY CISPLATIN AT A DOSE OF 75MG/M2 FOR THE FIRST-LINE TREATMENT OF ADVANCED OVARIAN CANCER
D - 58 CHANGE IN DOSING INTERVAL TO ONCE-DAILY ADMINISTRATION
D - 59 REDUCTION OF ELEVATED LDL-C IN A NEW, HIGHER STRENGTH TABLET, 0.8MG, AND FOR EXTENSION OF THE DOSAGE RANGE TO 0.8MG DAILY
D - 60 ADDITION OF A POST-OPERATIVE DOSING REGIMEN
D - 61 ONCE WEEKLY DOSING FOR THE TREATMENT OF POSTMENOPAUSAL OSTEOPOROSIS
D - 62 ONCE WEEKLY DOSING FOR THE PREVENTION OF POSTMENOPAUSAL OSTEOPOROSIS
D - 63 TO ALLOW A TITRATION DOSING REGIMEN USING A 25MG DOSE
D - 64 INCREASING DOSAGE FOR NERVE BLOCK ANESTHESIA USING NAROPIN 7.5MG/ML AND FOR EXTENDING THE DURATION OF TREATMENT FOR POSTOPERATIVE ANALGESIA USING NAROPIN 2MG/ML
D - 65 CHANGE DOSING AND ADMINISTRATION TO INDICATE MAINTENANCE OF WEIGHT LOSS OVER AN 18 MONTH PERIOD THUS EXTENDING THE USE OF THIS DRUG FROM ONE TO TWO YEARS
D - 66 DOSING RECOMMENDATIONS FOR PATIENTS UNDERGOING PCI
D - 67 SHORTER TREATMENT COURSE OF THREE DAYS IN THE TREATMENT OF RECURRENT EPISODES OF GENITAL HERPES
D - 68 CHANGE OF ADMIN RATE FOR INFUSION OF AREDIA FOR TREATMENT OF MODERATE AND SEVERE HYPERCALCEMIA OF MALIGNANCY FROM 24 HOURS TO 2 HOURS UP TO BUT NOT INCLUDING 24 HOURS
D - 69 SHORTENED DOSING REGIMEN TO 5 DAYS FOR THE TREATMENT OF ACUTE EXACERBATION OF CHRONIC BRONCHITIS
D - 70 80MG ONCE DAILY DOSING REGIMEN
D - 71 EIGHT WEEK DOSING REGIMEN
D - 72 INFORMATION REGARDING INCREASED RATE OF INFUSION FOR DEPACON
D - 73 ONCE A WEEK DOSING FOR THE TREATMENT OF POSTMENOPAUSAL OSTEOPOROSIS
D - 74 ONCE A WEEK DOSING FOR THE PREVENTION OF POSTMENOPAUSAL OSTEOPOROSIS
D - 75 INTERMITTENT DOSING REGIMEN, STARTING DAILY DOSE 14 DAYS PRIOR TO THE ANTICIPATED ONSET OF MENSTRUATION THROUGH THE FIRST FULL DAY OF MENSES AND REPEATING WITH EACH NEW CYCLE
D - 76 FOR USE ON AN 'AS NEEDED' OR PRN BASIS FOR THE MANAGEMENT OF NASAL SYMPTOMS IN PATIENTS FOR WHOM THE DRUG IS INDICATED
D - 77 ADDITION OF 20MG AND 40MG DAILY AS OPTIONAL STARTING DOSES WITH 40MG INTENDED FOR PATIENTS WHO REQUIRE A LARGE REDUCTION IN LDL-C (MORE THAN 45%)
D - 78 USE OF FLEXERIL 5MG FOR THE RELIEF OF MUSCLE SPASM ASSOCIATED WITH ACUTE, PAINFUL, MUSCULOSKELETAL CONDITIONS
D - 79 NEW LOWER STARTING DOSE FOR TREATMENT OF MODERATE TO SEVERE VASOMOTOR SYMPTOMS AND/OR MODERATE TO SEVERE SYMPTOMS OF VULVAR AND VAGINAL ATROPHY ASSOCIATED W/ THE MENOPAUSE
D - 80 CHANGE OF DOSING SCHEDULE FOR LANTUS FROM ONCE DAILY AT BEDTIME TO FLEXIBLE DAILY DOSING
D - 81 NEW LOWER STARTING DOSE FOR THE PREVENTION OF POSTMENOPAUSAL OSTEOPORSIS
D - 82 USE OF PREMARIN 0.3 MG AND 0.45 MG FOR THE PREVENTION OF POSTMENOPAUSAL OSTEOPOROSIS
D - 83 750 MG, ONCE DAILY FOR 5 DAYS FOR COMMUNITY ACQUIRED PNEUMONIA (CAP)
D - 84 ONCE-A-DAY DOSING OF FLOXACIN OTIC FOR THE TREATMENT OF ADULTS AND PEDIATRIC PATIENTS(AGES 6 MO & OLDER) W/ OTITIS EXTERNA CAUSED BY SUSCEPTIBLE STRAINS OF E.COLI, P.AERUGINOSA AND S.AUREUS
D - 85 LOWER RECOMMENDED STARTING DOSE GUIDELINES FOR TREATMENT OF MODERATE TO SEVERE VASOMOTOR SYMPTOMS ASSOCIATED WITH THE MENOPAUSE
D - 86 FOR USE IN SELECT EXTERNAL INSULIN PUMPS
D - 87 ADDITION OF ONCE-WEEKLY DOSING FOR THE TREATMENT TO INCREASE BONE MASS IN MEN WITH OSTEOPOROSIS
D - 88 NEW DOSING RANGE OF 200-400MG PER DAY IN TWO DIVIDED DOSES FOR ADULTS WITH PARTIAL SEIZURES
D - 89 USE OF REYATAZ 300 MG/RITONAVIR 100 MG ONCE DAILY FOR TREATMENT IN HIV-INFECTED ANTIRETROVIRAL-EXPERIENCED PATIENTS
D - 90 ADDITION OF DAYTIME ADMINISTRATION TO TREAT VULVOVAGINAL CANDIDIASIS
D - 91 ALTERNATE INTERMITTENT DOSING REGIMEN
D - 92 ALTERNATIVE DOSAGE OF 1000MG ONCE DAILY AT BEDTIME
D - 93 ALTERNATE TWO OR THREE TIMES DAILY DOSING REGIMENS
D - 94 NEW MAXIMUM DOSAGE OF 72 MG/DAY IN ADOLESCENTS 13-17 YEARS OF AGE WITH ATTENTION DEFECIT HYPERACTIVITY DISORDER (ADHD)
D - 95 BROADENED INITIAL STARTING DOSE FOR HYPERTENSION FROM 50 MG TO 100 MG TO 25 MG TO 100 MG DOSE RANGE
D - 96 ONCE-MONTHLY TREATMENT OF POSTMENOPAUSAL OSTEOPOROSIS WITH BONIVA (IBANDRONATE SODIUM) 150 MG TABLETS
D - 97 PED CANCER PT POPULATION EXPANDED TO INCLUDE PTS 6 MOS UP TO BUT NOT INCLUDING 4 YRS AND DOSING INSTRUCTIONS TO ADMIN 30 MIN BEFPRE CHEMO WITH SECOND AND THIRD DOSES 4 & 8 HOURS AFTER FIRST DOSE
D - 98 DOSING FOR PED SURGICAL PTS EXPANDED TO INCLUDE PTS 1 MONTH UP TO BUT NOT INCLUDING 2 YEARS OF AGE
D - 99 ONCE DAILY ADMINISTRATION FOR THE TREATMENT OF HIV INFECTION IN THERAPY NAIVE ADULT PATIENTS
D - 100 750 MG ONCE DAILY FOR FIVE DAYS FOR THE TREATMENT OF ACUTE BACTERIAL SINUSITIS
D - 101 ONCE DAILY IN CHRONIC IDIOPATHIC UTICARIA FOR ADULTS AND CHILDREN 12 YEARS OF AGE AND OLDER
D - 102 NEW DOSING REGIMEN OF ONE SPRAY TWICE DAILY FOR SEASONAL ALLERIC RHINITIS IN PATIENTS 12 YRS OF AGE AND OLDER
D - 103 NEW DOSING RECOMMENDATION FOR THE TREATMENT OF RECURRENT GENITAL HERPES IN IMMUNOCOMPETENT PATIENTS, SPECIFICALLY A REDUCTION IN COURSE OF THERAPY FROM FAMCICLOVIR 125 MG TWICE-A-DAY FOR 5 DAYS TO 1000 MG TWICE-A-DAY FOR 1 DAY.
D - 104 0.5MG/0.1MG FOR THE TREATMENT OF MODERATE TO SEVERE VASOMOTOR SYMPTOMS ASSOCIATED WITH MENOPAUSE IN WOMEN WHO HAVE A UTERUS
D - 105 USE OF ACTONEL 75MG TWO CONSECUTIVE DAYS PER MONTH FOR THE PREVENTION AND TREATMENT OF POSTMENOPAUSAL OSTEOPOROSIS
D - 106 FIVE DAY TREATMENT OF SELECTED SUSCEPTIBLE STRAINS OF STREPTOCOCCUS PNEUMONIAE, HAEMOPHILUS INFLUENZA, MYCOPLASMA PNEUMONIAE, AND CHLAMYDIA PNEUMONIAE FOR COMMUNITY-ACQUIRED PNEUMONIA
D - 107 PROVIDES FOR THE COMBINATION TABLET OF 70MG ALENDRONATE AND 5600 IU OF VITAMIN D3 FOR THE TREATMENT OF OSTEOPOROSIS IN POSTMENOPAUSAL WOMEN AND TO INCREASE BONE MASS IN MEN WITH OSTEOPOROSIS
D - 108 TREATMENT OF COMPLICATED URINARY TRACT INFECTION AND ACUTE PYELONEPHRITIS WITH LEVAQUIN 750MG ONCE DAILY FOR FIVE DAYS
D - 109 PROVIDE FOR THE USE OF A LOWER DOSE FOR THE TREATMENT OF ADULTS WITH CHRONIC PHASE CHRONIC MYELOID LEUKEMIA (CML) WITH RESISTANCE OR INTOLERANCE TO PRIOR THERAPY INCLUDING IMATINIB MESYLATE
D - 110 TREATMENT OF SCHIZOPHRENIA IN ADOLESCENTS AGED 13-17
D - 111 PROVIDES FOR ONCE DAILY USE OF CIALIS, 2.5 MG AND 5 MG, FOR THE TREAMTENT OF ERECTILE DYSFUNCTION
D - 112 PROVIDES FOR PEDIATRIC PUMP USE
D - 113 ONCE DAILY DOSING REGIMEN FOR PATIENTS WHO BECOME CONSTIPATED ON TWICE DAILY REGIMEN
D - 114 NEW DOSING RECOMMENDATIONS FOR USE OF SIROLIMUS IN COMBINATION WITH CYCLOSPORINE FOR THE PROPHYLAXIS OF REJECTION IN HIGH-RISK RENAL TRANSPLANT RECIPIENTS
D - 115 STARTING DOSE OF 15MG/DAY FOR MONOTHERAPY IN ACUTE TREATMENT OF BIPOLAR DISORDER, MANIC OR MIXED
D - 116 ALTERNATIVE DOSING REGIMEN ATAZANAVIR SULATE CO-ADMINISTERED WITH RITONAVIR FOR THE TREATMENT OF HIV-1 INFECTION IN TREATMENT NAIVE PATIENTS
D - 117 50 MG TABLET FOR INITIATION OF DOSE TITRATION FOR BIPOLAR DISORDER
D - 118 TWO 400MG TABLETS ONCE DAILY, CO-ADMINISTERED WITH 100MG RITONAVIR
D - 119 DOSING RECOMMENDATIONS FOR HIV INFECTED PEDIATRIC PATIENTS 6 TO LESS THAN 18 YEARS OF AGE
D - 120 DOSING REGIMEN ADJUSTMENTS
D - 121 CHANGE TO REMOVE 20 MG MAXIMUM DOSAGE RESTRICTION
D - 122 USE OF VAGIFEM 10 MCG FOR THE TREATMENT OF ATROPHIC VAGINITIS DUE TO MENOPAUSE
D - 123 ALTERNATIVE DOSING REGIMEN DOSE OF 20 MG/METER SQUARE BY CONTINUOUS INTRAVENOUS INFUSION OVER 1 HOUR REPEATED DAILY FOR 5 DAYS
D - 124 ONCE DAILY DOSING REGIMEN IN ADULT PATIENTS WITH LESS THAN THREE LOPINAVIR RESISTANCE-ASSOCIATED SUBSTITUTIONS
D - 125 EXTEND CURRENT DOSING REGIMEN TO 900MG (2-450MG TABLETS) ONCE A DAY WITHIN 10 DAYS OF TRANSPLANTATION UNTIL 200 DAYS POST-TRANSPLANTATION FOR THE PREVENTION OF CYTOMEGALOVIRUS (CMV) DISEASE IN ADULT KIDNEY TRANSPLANT PATIENTS AT HIGH RISK.
D - 126 CHANGE DOSAGE REGIMEN FROM 250MG TO 500MG
D - 127 DOSING REGIMEN FOR ADULT PATIENTS WITH CHRONIC HEPATITIS B (CHB) AND DECOMPENSATED LIVER DESEASE
D - 128 SINGLE IV DOSE OF FOSAPREPITANT 150MG, DOSED CONCOMITANTLY WITH 5HT3 RECEPTOR ANTAGONIST & CORTICOSTEROID, FOR PREVENTION OF ACUTE & DELAYED NAUSEA & VOMITING ASSOCIATED WITH INITIAL AND REPEAT COURSES OF HIGHLY EMETOGENIC CANCER CHEMO
D - 129 800/100 MG DARUNAVIR/RITONAVIR, ONCE DAILY, IN TREATMENT -EXPERIENCED HIV-1 INFECTED PATIENTS WITH NO DARUNIVIR RESISTANCE ASSOCIATED SUBSITUTIONS
D - 130 DOSING RECOMMENDATIONS FOR TREATMENT OF HIV-1 INFECTION DURING PREGNANCY BASED ON DATA FROM STUDY AI424-182, A STUDY OF ATAZANAVIR/RITONAVIR IN COMBINATION WITH ZIDOVUDINE/LAMIVUDINE IN HIV INFECTED PREGNANT WOMEN
D - 131 EVERY 6 TO 8 WEEKS FOR THE 120MG STRENGTH FOR PATIENTS WHO ARE CONTROLLED ON SOMATULINE DEPOT 60MG OR 90MG
D - 132 45MG FOR 6 MONTH ADMINISTRATION
D - 133 NEW EFFICACY DATA AND DOSING REGIMEN FOR PREGNANCY IN NORMAL OVULATORY WOMEN UNDERGOING CONTROLLED OVARIAN STIMULATION AS PART OF AN IVF OR INTRACYTOPLASMIC SPERM INJECTION (ICSI) CYCLE
D - 134 INCREASING MAXIMUM DOSING OF PATIENTS WITH SCHIZOPHRENIA TO 160 MG/DAY
D - 135 UPDATE LABELING WITH ONCE DAILY DOSING IN HIV-1 INFECTED, TREATMENT-NAIVE PEDIATRIC PATIENTS 12 TO LESS THAN 18 YEARS OF AGE
D - 136 ALTERNATE DOSING REGIMEN FOR UNCOMPLICATED URETHRAL OR ENDOCERVICAL INFECTION CAUSED BY CHLAMYDIA TRACHOMATIS, ADMINISTER 200 MG BY MOUTH ONCE-A-DAY FOR 7 DAYS
D - 137 NEW LOWER DOSING REGIMEN FOR REVATIO IN THE TREATMENT OF PULMONARY ARTERIAL HYPERTENSION (WHO GROUP 1) IN ADULTS
D - 138 80 MG DOSING REGIMEN FOR THE RISK REDUCTION OF REBLEEDING OF GASTRIC AND DUODENAL ULCERS IN THE FIRST 72 HOURS FOLLOWING THERAPEUTIC ENDOSCOPY IN ADULTS
D - 139 Additional information added to the Dosing and Administration section of the labeling regarding the administration of Bravelle and Menopur in the same syringe to ovulatory women as part of an ART cycle
GAIN - 1 Generating Antibiotic Incentives Now
I - 0 NEW INDICATION (SEE INDIVIDUAL REFERENCES)
I - 1 DYSMENORRHEA
I - 2 CHOLANGIOPANCREATOGRAPHY
I - 3 INTRAVENOUS DIGITAL SUBTRACTION ANGIOGRAPHY
I - 4 PERIPHERAL VENOGRAPHY (PHLEBOGRAPHY)
I - 5 HYSTEROSALPINGOGRAPHY
I - 6 TREATMENT OF JUVENILE ARTHRITIS
I - 7 BIOPSY PROVEN MINIMAL CHANGE NEPHROTIC SYNDROME IN CHILDREN
I - 8 ADULT INTRAVENOUS CONTRAST-ENHANCED COMPUTED TOMOGRAPHY OF THE HEAD AND BODY
I - 9 PREVENTION OF POSTOPERATIVE NAUSEA AND VOMITING
I - 10 PREVENTION OF POSTOPERATIVE DEEP VENOUS THROMBOSIS AND PULMONARY EMBOLISM IN TOTAL HIP REPLACEMENT SURGERY
I - 11 RELIEF OF MILD TO MODERATE PAIN
I - 12 TREATMENT OF CUTANEOUS CANDIDIASIS
I - 13 URINARY TRACT INFECTION (UTI) PREVENTION FOR PERIODS UP TO FIVE MONTHS IN WOMEN WITH A HISTORY OF RECURRENT UTI
I - 14 SEBORRHEIC DERMATITIS
I - 15 PHOTOPHERESIS IN THE PALLIATIVE TREATMENT OF SKIN MANIFESTATIONS OF CUTANEOUS T-CELL LYMPHOMA IN PERSONS NOT RESPONSIVE TO OTHER TREATMENT
I - 16 STIMULATE THE DEVELOPMENT OF MULTIPLE FOLLICLES/OOCYTES IN OVULATORY PATIENTS PARTICIPATING IN AN IN VITRO FERTILIZATION PROGRAM
I - 17 MANAGEMENT OF CONGESTIVE HEART FAILURE
I - 18 ENDOSCOPIC RETROGRADE PANCREATOGRAPHY
I - 19 HERNIOGRAPHY
I - 20 KNEE ARTHROGRAPHY
I - 21 HIGH DOSE METHOTREXATE WITH LEUCOVORIN RESCUE IN COMBINATION WITH OTHER CHEMOTHERAPEUTIC AGENTS TO DELAY RECURRENCE IN PATIENTS WITH NONMETASTATIC OSTEOSARCOMA WHO HAVE UNDERGONE SURGICAL RESECTION OR AMPUTATION FOR THE PRIMARY TUMOR
I - 22 RESCUE AFTER HIGH-DOSE METHOTREXATE THERAPY IN OSTEOSARCOMA
I - 23 SHORT-TERM TREATMENT OF ACTIVE BENIGN GASTRIC ULCER
I - 24 TREATMENT OF RHEUMATOID ARTHRITIS
I - 25 ADULT INTRA-ARTERIAL DIGITAL SUBTRACTION ANGIOGRAPHY OF THE HEAD, NECK, ABDOMINAL, RENAL AND PERIPHERAL VESSELS
I - 26 TREATMENT OF LIVER FLUKES
I - 27 ADJUNCTIVE THERAPY TO DIET TO REDUCE THE RISK OF CORONARY ARTERY DISEASE
I - 28 SELECTIVE ADULT VISCERAL ARTERIOGRAPHY
I - 29 METASTATIC BREAST CANCER IN PREMENOPAUSAL WOMEN AS AN ALTERNATIVE TO OOPHORECTOMY OR OVARIAN IRRADIATION
I - 30 TREATMENT OF TINEA PEDIS
I - 31 CONTRAST ENHANCEMENT AGENT TO FACILITATE VISUALIZATION OF LESIONS IN THE SPINE AND ASSOCIATED TISSUES
I - 32 PEDIATRIC MYELOGRAPHY
I - 33 ORAL USE OF DILUTED OMNIPAQUE INJECTION IN ADULTS FOR CONTRAST ENHANCED COMPUTED TOMOGRAPHY OF THE ABDOMEN
I - 34 ORAL USE IN ADULTS FOR PASS-THROUGH EXAMINATION OF THE GASTROINTESTINAL TRACT
I - 35 PEDIATRIC CONTRAST ENHANCEMENT OF COMPUTED TOMOGRAPHIC HEAD IMAGING
I - 36 ARTHROGRAPHY OF THE SHOULDER JOINTS IN ADULTS
I - 37 RADIOGRAPHY OF THE TEMPOROMANDIBULAR JOINT IN ADULTS
I - 38 CONTRAST ENHANCEMENT AGENT TO FACILITATE VISUALIZATION OF LESIONS OF THE CENTRAL NERVOUS SYSTEM IN CHILDREN (2 YEARS OF AGE AND OLDER)
I - 39 TREATMENT OF ACUTE MYOCARDIAL INFARCTION
I - 40 PRIMARY NOCTURNAL ENURESIS
I - 41 MIGRAINE HEADACHE PROPHYLAXIS
I - 42 HERPES ZOSTER
I - 43 HERPES SIMPLEX ENCEPHALITIS
I - 44 MAINTENANCE THERAPY IN HEALED DUODENAL ULCER PATIENTS AT DOSE OF 1 GRAM TWICE DAILY
I - 45 ACUTE TREATMENT OF VARICELLA ZOSTER VIRUS
I - 46 USE IN PEDIATRIC COMPUTED TOMOGRAPHIC HEAD AND BODY IMAGING
I - 47 TREATMENT OF PEDIATRIC PATIENTS WITH SYMPTOMATIC HUMAN IMMUNODEFICIENCY VIRUS (HIV) DISEASE
I - 48 PEDIATRIC ANGIOCARDIOGRAPHY
I - 49 TREATMENT OF TRAVELERS' DIARRHEA DUE TO SUSCEPTIBLE STRAINS OF ENTEROTOXIGENIC ESCHERICHIA COLI
I - 50 FOR USE IN WOMEN WITH AXILLARY NODE-NEGATIVE BREAST CANCER
I - 51 TREATMENT OF PRIMARY DYSMENORRHEA AND FOR THE TREATMENT OF IDIOPATHIC HEAVY MENSTRUAL BLOOD LOSS
I - 52 PEDIATRIC EXCRETORY UROGRAPHY
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

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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 June 2014
Patent and Generic Drug Product Data Last Updated July 29, 2014

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