Gildess 1/20

Product manufactured by Par Pharmaceutical

Application Nr Approved Date Route Status External Links
ANDA077077 2012-07-24 Oral RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

Indications And Usage Norethindrone Acetate And Ethinyl Estradiol Tablets, Usp Are Indicated For The Prevention Of Pregnancy In Women Who Elect To Use Oral Contraceptives As A Method Of Contraception. Oral Contraceptives Are Highly Effective. Table I 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 Methods Can Result In Lower Failure Rates. Table I: Lowest Expected And Typical Failure Rates During The First Year Of Continuous Use Of A Method % Of Women Experiencing An Unintended Pregnancy In The First Year Of Continuous Use Method Lowest Expected* Typical** (no Contraception) (85) (85) Oral Contraceptives 3 Combined 0.1 N/a*** Progestin Only 0.5 N/a*** Diaphragm With Spermicidal Cream Or Jelly 6 20 Spermicides Alone (foam, Creams, Gels, Vaginal Suppositories, And Vaginal Film) 6 26 Vaginal Sponge Nulliparous 9 20 Parous 20 40 Implant 0.05 0.05 Injection: Depot Medroxyprogesterone Acetate 0.3 0.3 Iud Progesterone T 1.5 2.0 Copper T 380a 0.6 0.8 Lng 20 0.1 0.1 Condom Without Spermicides Female 5 21 Male 3 14 Cervical Cap With Spermicidal Cream Or Jelly Nulliparous 9 20 Parous 26 40 Periodic Abstinence (all Methods) 1 To 9 25 Withdrawal 4 19 Female Sterilization 0.5 0.5 Male Sterilization 0.10 0.15 Adapted From Ra Hatcher Et Al., Reference 7. * The Authors’ Best Guess Of The Percentage Of Women Expected To Experience An Accidental Pregnancy Among Couples Who Initiate A Method (not Necessarily For The First Time) And Who Use It Consistently And Correctly During The First Year If They Do Not Stop For Any Other Reason. ** This Term Represents “typical” Couples Who Initiate Use Of A Method (not Necessarily For The First Time), Who Experience An Accidental Pregnancy During The First Year If They Do Not Stop Use For Any Other Reason. *** N/a—data Not Available.

All Formulated Excipients (6 Total)

Name Structure Kind Function Status
1. Silicon Dioxide SILICON DIOXIDE Unresolved AC-Anticaking agent , MISC-Miscellaneous , STAB-Stabilizer GRAS-Generally recognized as safe.
2. Croscarmellose Sodium CROSCARMELLOSE SODIUM Unresolved
3. Lactose Monohydrate LACTOSE MONOHYDRATE Molecular
4. Magnesium Stearate MAGNESIUM STEARATE Molecular AF-Antifoaming (or defoaming) agent , MISC-Miscellaneous REG-Food additives for which a petition has been filed and a regulation issued.
5. Polyethylene Glycol 400 POLYETHYLENE GLYCOL 400 Unresolved
6. Polyethylene Glycol 8000 POLYETHYLENE GLYCOL 8000 Unresolved

Active Ingredients ( 2 Total)

Name Structure ZINC ID(s)
1. Ethinyl Estradiol
2. Norethindrone Acetate

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