HLPressRelease has announced that the HalfLytely ® and Bisacodyl Tablets Bowel Prep Kit (PEG- 3350, sodium chloride, sodium bicarbonate, potassium chloride for oral solution and bisacodyl delayed release tablets) is available nationwide as a prescription preparation for bowel cleansing prior to colonoscopy.HalfLytely ® also maintains efficacy...
author: JLUMSDEN
subject: HLPressRelease
HLPressRelease page 1
author: JLUMSDEN
subject: HLPressRelease
Braintree makes lavages and drugs for constipation and Renal Failure The product information presented here is intended for use in the United States only.glycol 3350, NF powder for solution) available in...
Braintree makes lavages and drugs for constipation NuLYTELY ® (PEG-3350, sodium chloride, sodium bicarbonate and potassium chloride for oral solution), a reformulation of the original GoLYTELY, provides patients with an improved taste and a 52% less sodium alternative to the other lavages on the market.
http://www.fda.gov/cder/dmf/text/4Q2003ACTIVETYPE2TEXT.txt CHLOROTHIAZIDE 1049 21-Mar-67 "GANES CHEMICALS, INC., PENNSVILLE DIVISION" PHENOBARBITAL 1050 22-Mar-67 GANES CHEMICALS INC SECOBARBITAL SODIUM USP 1051 23-Mar-67 "GANES CHEMICALS, INC., PENNSVILLE DIVISION" AMOBARBITAL 1076 15-Aug-67 AJINOMOTO CO NY INC AMINO ACID PRODUCTS 1166 09-Apr-68 GANES CHEMICALS INC ALLYLISOBUTYLBARBITURIC ACID & SODIUM ALLYLISOBUTYLBARBITURATE 1169 19-Apr...
What's new at CDER by Date - U.S
author: Paul Stauffer
CDER: Previous News Items, 2004 FDA Home Page | CDER Home Page | CDER Site Info | Contact CDER | What's New @ CDER - Search - Previous News Items, 2004 February 6, 2004 -FDA approves Oxycodone Hydrochloride (non combination product) February 5, 2004 FDA approves first-time generic TriLyte (Polyethylene Glycol 3350, Potassium Chloride, Sodium Bicarbonate and Sodium Chloride ...
http://www.fda.gov/cder/orange/appendix_a.txt 3, ACETAMINOPHEN ACETAMINOPHEN W/ CODEINE PHOSPHATE #3, ACETAMINOPHEN ACETAMINOPHEN W/ CODEINE PHOSPHATE, ACETAMINOPHEN ACETAMINOPHEN W/ CODEINE, ACETAMINOPHEN ACETAMINOPHEN, ACETAMINOPHEN (OTC) ACETAMINOPHEN, ASPIRIN AND CAFFEINE, ACETAMINOPHEN (OTC) ACETAMINOPHEN, ASPIRIN, AND CODEINE PHOSPHATE, ACETAMINOPHEN ACETAMINOPHEN, BUTALBITAL AND CAFFEINE, ACETAMINOPHEN ACETAMINOPHEN,...
Prescription and OTC Drug Product List 12/2000 Prescription and Over-the-Counter Drug Product List - 20th Edition Cumulative Supplement Number 12: December 2000 [ Prescription - OTC ] ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE - ADD - BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE TABLET; ORAL - ADD - GEL; TOPICAL OXYCODONE AND ACETAMINOPHEN - ADD - BENZACLIN - ADD - AA WATSON LABS...
FDA Drug Approvals List- March 1999 Drug Approvals for March 1999 Definitions and Notes March 1999 Original New Drug Applications Original Application #: 020966 Approval Date: 30-MAR-99 Trade Name: SPORANOX Chemical Type: 3 Therapeutic Potential: S Dosage Form: INJECTABLE Applicant: JANSSEN RESEARCH FDN DIV JOHNSON AND JOHNSON Active Ingredient(s): ITRACONAZOLE OTC/RX Status: RX Indication(s): For the treatment of...
http://www.plantsci.cam.ac.uk/plantsci/admin/forms/ChemCategD.pdf page 4 4 PHENYL SEPHAROSE PHENYLALANINE ( L, D, or D/ L) PHLEOMYCIN PHOSPHATIDIC ACIDS (L- a-) PHOSPHATIDYL INOSITOL PHOSPHATIDYLCHOLINE / LECITHIN PHOSPHATIDYLETHOLAMIDE LPHOSPHATYDYLCHOLINE DIPALMITOYL (LPHOSPHOENOLPYRUVATE / PEP PHOSPHOGLUCONIC ACID PHOSPHOGLYCERIC ACID (D(-) 3-) PHOSPHOGLYCOLIC ...
DDPA February 1995 Drug and Device Product Approvals for February 1995 ***ORIGINAL AND SUPPLEMENTAL NDAs*** FOR NEW DRUG PRODUCTS 19-797 NULYTELY-FLAVORED BRAINTREE POLYETHYLENE GLYCOL 3350 18-NOV-94 (POWDER BRAINTREE, MA 420GM/BOT (SUPPL-002)FOR RECONSTITUTION) 02184 POTASSIUM CHLORIDE 1.48GM/BOT SODIUM BICARBONATE 5.72GM/BOT SODIUM CHLORIDE 11.2GM/BOT ...
Drug Approvals for December 1997 Also provides for the addition of Haemophilus influenzae to the presently approved indication for secondary bacterial infections of acute bronchitis Application #: 020522 Efficacy Supplement#: 004 Type: SE1 to Original New Drug Application Approval Date: 17-DEC-97 Trade Name: NUTROPIN AQ Dosage Form: INJECTABLE Applicant: GENENTECH INC Active Ingredient(s): SOMATROPIN, BIOSYNTHETIC...
http://www.fda.gov/cder/da/ddpa93.wpd 19 050 SUFENTA JANSSEN SUFENTANIL CITRATE 03 19 93 (INJECTABLE) PISCATAWAY, NJ EQ 0.05MG BASE/ML 08854 (REVISED LABELING DESCRIPTION; CLINICAL PHARMACOLOGY; CLINICAL STUDIES; INDICATIONS AND USAGE; WARNINGS; PRECAUTIONS; ADVERSE REACTIONS; OVERDOSAGE; DOSAGE AND ADMINISTRATION) 19 898 PRAVACHOL BRISTOL MYERS SQUIBB PRAVASTATIN SODIUM 03 22 93 (TABLET) PRINCETON, NJ 10MG 08543 20MG...
http://www.fda.gov/cder/da/ddpa91.wpd DEPARTMENT OF HEALTH AND HUMAN SERVICES, PUBLIC HEALTH SERVICE NDA NUMBER APPROVAL DATE (CLASSIFICATION)TRADE NAME (DOSAGE FORM)APPLICANTACTIVE INGREDIENT(S) STRENGTH(S) CLASSIFICATION(S) ***ORIGINAL AND SUPPLEMENTAL NDAs*** FOR NEW DRUG PRODUCTS 20 057 CEREDASE GENZYME ALGLUCERASE 04 05-91 (INJECTABLE) BOSTON, MA 80 UNITS/ML (1 A, V*) 02111 (BETA-GLUCOCEREBROSIDASE ENZYME...
http://www.fda.gov/cder/da/ddpa92.wpd 20 005 CARDENE SR SYNTEX NICARDIPINE HYDROCHLORIDE 01 23 92 (CAPSULE, PALO ALTO, CA 30MG EXTENDED RELEASE) 94304 45MG 60MG (CALCIUM ION INFLUX INHIBITOR) [HYPERTENSION] 73 243* LOPERAMIDE HCL PERRIGO LOPERAMIDE HYDROCHLORIDE 01 21 92 (SOLUTION) ALLEGAN, MI 1MG/5ML 49010 (ANTIDIARRHEAL) (OTC) 81 264 BENZTROPINE MESYLATE MUTUAL PHARM BENZTROPINE MESYLATE 01 23 92 (TABLET) PHILADELPHIA,...
Braintree makes lavages and drugs for constipation announces the acquisition of Axid Oral Solution (nizatidine) from Reliant Pharmaceuticals.- Press Release - June 29, 2005 - Braintree Laboratories' HalfLytely® and Bisacodyl Tablets Bowel Prep Kit (PEG-3350, sodium chloride, sodium bicarbonate and potassium chloride for oral solution and bisacodyl delayed release tablets) is now available in convenient...
Cancer.gov - Gastrointestinal complications (PDQ®) 1 bisacodyl tablet at bedtimebisacodyl may be increased gradually to 3 tabletsBisacodyl must be excreted in bile to be active and is not effective with biliary...
http://www.fda.gov/cder/dmf/xls/4Q2003ACTIVETYPE2EXCEL.xls CHLOROTHIAZIDE GANES CHEMICALS, INC., PENNSVILLE DIVISION PHENOBARBITAL GANES CHEMICALS INC SECOBARBITAL SODIUM USP GANES CHEMICALS, INC., PENNSVILLE DIVISION AMOBARBITAL AJINOMOTO CO NY INC AMINO ACID PRODUCTS GANES CHEMICALS INC ALLYLISOBUTYLBARBITURIC ACID & SODIUM ALLYLISOBUTYLBARBITURATE GANES CHEMICALS, INC., PENNSVILLE DIVISION PENTOBARBITOL AND SODIUM PENTOBARBITOL, USP,...
HLPressRelease page 2
author: JLUMSDEN
subject: HLPressRelease
Paragraph IV Patent Certifications - DRUG NAME DOSAGE FORM STRENGTH RLD Acetaminophen Extended-release Tablets 650 mg Tylenol Acetaminophen/ Aspirin/ Caffeine Tablets 250 mg/250 mg/ 65 mg Excedrin (migraine) Acetaminophen and Tramadol Hydrochloride Tablets 325 mg/ 37.5 mg Ultracet Acyclovir Sodium1 Injection 50 mg/mL, 10 mL and 20 mL vials Zovirax Albuterol Sulfate Oral Syrup 2 mg(base)/ 5 mL Ventolin Albuterol...
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