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The strength is the amount of drug in the dosage form or a unit of the dosage form (e.g. 500 mg capsule, 250 Other medicines may also affect the drug dose.
 The majority oflabels, approval letters, reviews, and other information are available Even if drug products have the same active ingredient, dosage form, and
 The granularity of data often requires that more specific dosage form terms be in databases that track approved drug products, but also for drug products such
 2 Jul 2017 Processes in the manufacturing of solid-dosage forms have stayed relatively the same for The first 3D-printed drug approved by FDA in August 2015, however, But has FDA seen more from manufacturers on 3D printing,
 Brand Name: Epivir Other Names: 3TC Drug Class: Nucleoside Reverse Transcriptase Several FDA-approved drug labels may be available for lamivudine. . Patients with HIV-1 infection should receive only dosage forms appropriate for
 25 Nov 2014 Oral Solid Dosage Forms Pre/Post Approval Issues (1/94) The inspection team is expected to review other agency documents in preparation for . In most cases the manufacturing process for a new drug substance (new
 20 Dec 2016 Providing a more convenient and/or faster-acting dosage form of a well-chosen Approval of a new dosage form of a drug requires a new NDA. Upon filing an NDA, the FDA typically assigns an NDA classification code to
 Previously approved medications that have gained new FDA approval for the treatment of additional medical conditions.
 The following drugs have recently been approved by the FDA. Adzenys ER (amphetamine) is an extended-release liquid suspension formulation of the central
 For non-oral dosage forms, the test is as “drug release” rather than “dissolution” or any other appropriate method, for test for approval of generic semisolid
     
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