Simliya Kit
NDC Package 65862-886-88

EA - Billing unit of "each" is used when the product is dispensed in discreet units.

3 EA

Desogestrel And Ethinyl Estradiol And Ethinyl Estradiol

Kit - A packaged collection of related material.

SIMLIYATM (desogestrel and ethinyl estradiol tablets, USP and ethinyl estradiol tablets, USP) are indicated for the prevention of pregnancy in women who elect to use this product as a method of contraception. Oral contraceptives are highly effective. Table II lists the typical accidental pregnancy rates for users of combination oral contraceptives and other methods of contraception. The efficacy of these contraceptive methods, except sterilization, depends upon the reliability with which they are used. Correct and consistent use of these methods can result in lower failure rates.TABLE II: Percentage of women experiencing an unintended pregnancy during the first year of typical use and the first year of perfect use of contraception and the percentage continuing use at the end of the first year, United States.   % of Women Experiencing an Unintended Pregnancy within the First Year of Use % of Women Continuing Use at One YearaMethod(1)Typical Useb(2)Perfect Usec(3) (4)Chanced85 85  Spermicidese26 6 40 Periodic abstinence 25  63 Calendar  9  Ovulation Method  3  Sympto-Thermalf 2  Post-Ovulation  1  Withdrawal 19 4  Capg   Parous Women 40 26 42 Nulliparous Women 20 9 56 Sponge    Parous Women 40 20 42 Nulliparous Women 20 9 56 Diaphragmg20 6 56 Condomh   Female (Reality) 21 5 56 Male 14 3 61 Pill 5  71 Progestin Only  0.5  Combined  0.1  IUD    Progesterone T 2 1.5 81 Copper T 380A 0.8 0.6 78 LNg 20 0.1 0.1 81 Depo-Provera 0.3 0.3 70 Norplant and Norplant-2 0.05 0.05 88 Female sterilization 0.5 0.5 100 Male sterilization 0.15 0.1100 Adapted from Hatcher et al., 1998, ref #1.a) Among couples attempting to avoid pregnancy, the percentage who continue to use a method for one year. b) Among typical couples who initiate use of a method (not necessarily for the first time), the percentage who experience an accidental pregnancy during the first year if they do not stop use for any other reason. c) Among couples who initiate use of a method (not necessarily for the first time) and who use it perfectly (both consistently and correctly), the percentage who experience an accidental pregnancy during the first year if they do not stop use for any other reason. d) The percents becoming pregnant in columns (2) and (3) are based on data from populations where contraception is not used and from women who cease using contraception in order to become pregnant. Among such populations, about 89% become pregnant within one year. This estimate was lowered slightly (to 85%) to represent the percent who would become pregnant within one year among women now relying on reversible methods of contraception if they abandoned contraception altogether. e) Foams, creams, gels, vaginal suppositories, and vaginal film. f) Cervical mucus (ovulation) method supplemented by calendar in the pre-ovulatory and basal body temperature in the post-ovulatory phases. g) With spermicidal cream or jelly.h) Without spermicides.

Aurobindo Pharma Limited

Human Prescription Drug

ANDA206853

ANDA - A product marketed under an approved Abbreviated New Drug Application.

03-22-2017

12-31-2026

N

No