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(GEMCITABINE HCl) FOR INJECTION - Food and Drug …
the Gemzar plus cisplatin arm was 5.0 months compared to 4.1 months on the etoposide plus cisplatin arm (Logrank p=0.015, two-sided). The objective response rate for the Gemzar plus cisplatin arm was 33% compared to 14% on the etoposide plus cisplatin arm (Fisher’s Exact
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FOR INTRAVENOUS USE ONLY - Food and Drug …
www.accessdata.fda.govNDA 50-706/S-022 Page 3 MERREM® I.V. (meropenem for injection) FOR INTRAVENOUS USE ONLY To reduce the development of drug-resistant bacteria and maintain the effectiveness of
Effexor (venlafaxine hydrochloride) Tablets …
www.accessdata.fda.govEffexor ® (venlafaxine hydrochloride) Tablets Rx only . Suicidality and Antidepressant Drugs Antidepressants increased the risk compared …
Reference ID: 3101735 - Food and Drug …
www.accessdata.fda.govDocetaxel Injection in combination with doxorubicin and cyclophosphamide is indicated for the adjuvant treatment of patients with operable node-positive breast cancer.
Cytotec® - Food and Drug Administration
www.accessdata.fda.govcytotec® (misoprostol) warnings cytotec (misoprostol) administration to women who are pregnant can cause abortion, premature birth, or birth defects.
Venofer - Food and Drug Administration
www.accessdata.fda.govNDA 21-135/S-017 Page 3 Venofer ® (iron sucrose injection, USP) Rx Only DESCRIPTION Venofer® (iron sucrose injection, USP) is a brown, sterile, aqueous, complex of …
HIGHLIGHTS OF PRESCRIBING INFORMATION …
www.accessdata.fda.govweakness, diplopia, ptosis, dysphagia, dysphonia, dysarthria, urinary incontinence and breathing difficulties. These symptoms . FULL …
Namenda XR (memantine hydrochloride) capsules …
www.accessdata.fda.govThe most commonly observed adverse reactions seen in patients administered NAMENDA XR in the controlled clinical trial, defined as those occurring at a frequency of at least 5% in the
NOT FOR USE IN NEONATES CONTAINS BENZYL …
www.accessdata.fda.govDepo-Medrol® methylprednisolone acetate injectable suspension, USP NOT FOR USE IN NEONATES CONTAINS BENZYL ALCOHOL . Not For Intravenous Use . DESCRIPTION
HIGHLIGHTS OF PRESCRIBING INFORMATION …
www.accessdata.fda.govDacogen is indicated for treatment of patients with myelodysplastic syndromes (MDS) including previously treated and untreated, de novo and …
Diphenhydramine Hydrochloride Injection
www.accessdata.fda.govHOW SUPPLIED Diphenhydramine Hydrochloride Injection, USP is a clear and colorless solution available as: 50 mg/mL in a 1 mL prefilled single-use syringe.
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