Specifications | Approved Drug Products with Therapeutic Equivalence Evaluations 32nd Edition \Orange Book\ FDA/CDER |
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Specifications | Approved Drug Products with Therapeutic Equivalence Evaluations 32nd Edition \Orange Book\ FDA/CDER |
Business section |
Specifications | Approved Drug Products with Therapeutic Equivalence Evaluations 32nd Edition \Orange Book\ FDA/CDER |
Outline | Approved Drug Products with Therapeutic Equivalence Evaluations 32nd Edition Contents PREFACE 1.1 Content and Exclusion 1.2 Therapeutic Equivalence-Related Terms 1.3 Statistical Criteria for Bioequivalence 1.4 Reference Listed Drug 1.5 General Policies and Legal Status 1.6 Practitioner/User Responsibilities 1.7 Therapeutic Equivalence Evaluations Codes 1.8 Description of Special Situations 1.9 Therapeutic Equivalence Code Change for a Drug Entity 1.10 Change of the Therapeutic Equivalence for a Single Product 1.11 Discontinued Section 1.12 Changes to the Orange Book 1.13 Availability of the Edition |
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Content | 32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST APPENDIX A -PRODUCT NAME INDEX A - 44 ** P ** POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, DEXTROSE POTASSIUM CHLORIDE 10MEQ IN PLASTIC CONTAINER, POTASSIUM CHLORIDE POTASSIUM CHLORIDE 15MEQ IN DEXTROSE 5% AND LACTATED RINGER S IN PLASTIC CONTAINER, CALCIUM CHLORIDE POTASSIUM CHLORIDE 15MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC CONTAINER, DEXTROSE POTASSIUM CHLORIDE 15MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER, DEXTROSE POTASSIUM CHLORIDE 15MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER, DEXTROSE POTASSIUM CHLORIDE 15MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, DEXTROSE POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND LACTATED RINGER S IN PLASTIC CONTAINER, CALCIUM CHLORIDE POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC CONTAINER, DEXTROSE POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER, DEXTROSE POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER, DEXTROSE POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, DEXTROSE POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% IN PLASTIC CONTAINER, DEXTROSE POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% IN SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER, DEXTROSE POTASSIUM CHLORIDE 20MEQ IN PLASTIC CONTAINER, POTASSIUM CHLORIDE POTASSIUM CHLORIDE 20MEQ IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, POTASSIUM CHLORIDE POTASSIUM CHLORIDE 30MEQ IN DEXTROSE 5% AND LACTATED RINGER S IN PLASTIC CONTAINER, CALCIUM CHLORIDE POTASSIUM CHLORIDE 30MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC CONTAINER, DEXTROSE POTASSIUM CHLORIDE 30MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER, DEXTROSE POTASSIUM CHLORIDE 30MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER, DEXTROSE POTASSIUM CHLORIDE 30MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, DEXTROSE POTASSIUM CHLORIDE 30MEQ IN DEXTROSE 5% IN PLASTIC CONTAINER, DEXTROSE POTASSIUM CHLORIDE 30MEQ IN PLASTIC CONTAINER, POTASSIUM CHLORIDE POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% AND LACTATED RINGER S IN PLASTIC CONTAINER, CALCIUM CHLORIDE POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC CONTAINER, DEXTROSE POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER, DEXTROSE POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER, DEXTROSE POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, DEXTROSE POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% IN PLASTIC CONTAINER, DEXTROSE POTASSIUM CHLORIDE 40MEQ IN PLASTIC CONTAINER, POTASSIUM CHLORIDE POTASSIUM CHLORIDE 40MEQ IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, POTASSIUM CHLORIDE POTASSIUM CHLORIDE 5MEQ IN DEXTROSE 5% AND LACTATED RINGER S IN PLASTIC CONTAINER, CALCIUM CHLORIDE POTASSIUM CHLORIDE 5MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC CONTAINER, DEXTROSE POTASSIUM CHLORIDE 5MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER, DEXTROSE POTASSIUM CHLORIDE 5MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER, DEXTROSE POTASSIUM CHLORIDE 5MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, DEXTROSE POTASSIUM CHLORIDE IN PLASTIC CONTAINER, POTASSIUM CHLORIDE POTASSIUM CHLORIDE, POTASSIUM CHLORIDE POTASSIUM CITRATE, POTASSIUM CITRATE POTIGA, EZOGABINE POVIDONE IODINE, POVIDONE-IODINE (OTC) PRADAXA, DABIGATRAN ETEXILATE MESYLATE PRALIDOXIME CHLORIDE, PRALIDOXIME CHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE, PRAMIPEXOLE DIHYDROCHLORIDE PRAMOSONE, HYDROCORTISONE ACETATE PRANDIMET, METFORMIN HYDROCHLORIDE PRANDIN, REPAGLINIDE PRAVACHOL, PRAVASTATIN SODIUM PRAVASTATIN SODIUM, PRAVASTATIN SODIUM PRAZOSIN HYDROCHLORIDE, PRAZOSIN HYDROCHLORIDE PRECEDEX, DEXMEDETOMIDINE HYDROCHLORIDE PRECOSE, ACARBOSE PRED FORTE, PREDNISOLONE ACETATE PRED MILD, PREDNISOLONE ACETATE PRED-G, GENTAMICIN SULFATE PREDNICARBATE, PREDNICARBATE PREDNISOLONE SODIUM PHOSPHATE, PREDNISOLONE SODIUM PHOSPHATE PREDNISOLONE, PREDNISOLONE PREDNISONE INTENSOL, PREDNISONE |
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Following Datasheets | UCM071550_1 (15 pages) UCM071554_1 (7 pages) UCM071562_1 (18 pages) UCM071565_1 (10 pages) UCM071581_1 (9 pages) UCM071587_1 (11 pages) UCM071605_1 (8 pages) UCM071615_1 (11 pages) UCM071640_1 (7 pages) UCM071653_1 (11 pages) |
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