SPL Set ID: 4838c674-044e-46b2-81e7-c691b99d8fa5

1 drug(s) with this SPL Set ID

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leuprolide acetate LEUPROLIDE ACETATE
AMNEAL PHARMACEUTICALS LLC FDA Rx Only

Leuprolide acetate is a synthetic nonapeptide analog of naturally occurring gonadotropin releasing hormone (GnRH or LH-RH). The analog possesses greater potency than the natural hormone. The chemical name is 5-oxo-L-prolyl-L-histidyl-L-tryptophyl-L-seryl-L-tyrosyl-D-leucyl-L-leucyl-L-arginyl- N -ethyl-L-prolinamide acetate (salt). It has a molecular formula C 59 H 84 N 16 O 12 and the molecular weight 1209.4. The chemical structure is: Leuprolide Acetate Injection is a sterile, aqueous, clear, colorless solution intended for subcutaneous injection. It is available in a 2.8 mL multiple-dose vial containing leuprolide acetate USP, 5 mg/mL (equivalent to 4.75 mg leuprolide free base), sodium chloride (6.3 mg/mL) for tonicity adjustment, benzyl alcohol as a preservative (9 mg/mL), and water for injection. The pH may have been adjusted with sodium hydroxide and/or acetic acid. 1

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