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Www.accessdata.fda.gov

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Preview of https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021153s022lbl.pdf
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https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021153s022lbl.pdf (021153s022lbl.pdf)

593 KBEN 22 pages
NEXIUM (esomeprazole magnesium) Delayed-Release Capsules contain the active ingredient...
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Preview of https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021226s035lbl.pdf
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https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021226s035lbl.pdf (021226s035lbl.pdf)

1.27 MBfda/cderEN 42 pages
KALETRA is a co-formulation of lopinavir and ritonavir, with lopinavir inhibiting the HIV protease and ritonavir increasing lopinavir's plasma levels by...
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Preview of http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/208246s000lbl.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/208246s000lbl.pdf (208246s000lbl.pdf)

1.33 MBEN 36 pages
XELJANZ/XELJANZ XR is a Janus kinase (JAK) inhibitor used to treat moderately to severely active rheumatoid arthritis in adults who have had an inadequate...
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Preview of https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/216993s000lbl.pdf
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https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/216993s000lbl.pdf (216993s000lbl.pdf)

778 KBfda/cderEN 22 pages
VANFLYTA (quizartinib) is a kinase inhibitor for oral use, initially approved in the US in 2023.
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Preview of https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/017362s104lbl.pdf
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https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/017362s104lbl.pdf (017362s104lbl.pdf)

132 KBEN 7 pages
Progesterone injection USP, formulated in sesame oil for intramuscular use only, contains 50mg progesterone and 10% benzyl alcohol as a preservative. It promotes endometrial transformation and inhibits gonadotropin secretion to prevent ovulation.
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Preview of https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020496s021lbl.pdf
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https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020496s021lbl.pdf (020496s021lbl.pdf)

266 KBfdaEN 14 pages
AMARYL (glimepiride tablets) is an oral blood-glucose-lowering drug of the sulfonylurea class, available in 1, 2, and 4 mg strengths.
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Preview of https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021121s038lbl.pdf
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https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021121s038lbl.pdf (021121s038lbl.pdf)

1.02 MBFDAEN 32 pages
CONCERTA® (methylphenidate HCl) is a CNS stimulant indicated for Attention Deficit Hyperactivity Disorder (ADHD) treatment in children 6+ years, adolescents,...
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Preview of https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021457s036lbl.pdf
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https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021457s036lbl.pdf (021457s036lbl.pdf)

1.58 MBFDA/CDEREN 26 pages
PROAIR HFA is a beta2-adrenergic agonist indicated for treatment or prevention of bronchospasm in patients 4 years and older with reversible obstructive airway...
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Preview of https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021758s017lbl.pdf
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https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021758s017lbl.pdf (021758s017lbl.pdf)

265 KBfda/cderEN 6 pages
VANOS Cream is a corticosteroid indicated for relief of inflammatory and pruritic manifestations of corticosteroid responsive dermatoses in patients 12 years...
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Preview of https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/064071s006lbl.pdf
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https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/064071s006lbl.pdf (064071s006lbl.pdf)

302 KBfda/cderEN 2 pages
Penicillin V Potassium Tablets, USP, are an antibacterial drug used to treat or prevent infections caused by susceptible bacteria.
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Preview of https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/761075s004lbl.pdf
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https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/761075s004lbl.pdf (761075s004lbl.pdf)

802 KBfda/cderEN 20 pages
Fulphila (pegfilgrastim-jmdb) is a biosimilar to Neulasta (pegfilgrastim) used to decrease the incidence of infection, as manifested by febrile neutropenia, in...
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Preview of http://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/021436s018_StatR.pdf
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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/021436s018_StatR.pdf (021436s018_StatR.pdf)

613 KBEN 24 pages
The FDA's Center for Drug Evaluation and Research conducted a statistical review of a supplemental New Drug Application (sNDA) for Abilify (aripiprazole) as an...
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Preview of Ortho Tri-Cyclen Birth Control Prescription Insert. https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021690ppi.pdf
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Ortho Tri-Cyclen Birth Control Prescription Insert. https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021690ppi.pdf (021690ppi.pdf)

213 KBEN 18 pages
Oral contraceptives, also known as "birth control pills," are taken to prevent pregnancy and may also be used to treat moderate acne in females.
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