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FDA Approval Activities for this Drug…
Ortho-Prefest (estradiol/norgestimate) Tablets, King NDA 21-040/S10 1/23/03 1/27/03 Ortho-Prefest (17b-estradiol and 17b-estradiol/norgestimate), tablets [Patient Information] R.W. Johsnons NDA 21-040 10/22/99 12/30/99 12/30/99 ORTHO TRI-CYCLEN Lo (norgestimate/ethinyl estradiol) Tablets, Johnson & Johnson Pharmaceutical Research & Development, L.L.C. NDA 21-241 Sprintec-28 (Norgestimate & Ethinyl Estradiol) Tablets, 0.25 mg/0.035 mg respectively Barr, ANDA 75-804 Tri-Sprintec (Norgestimate and Ethinyl Estradiol) Tablets, 0.180 mg/0.035 mg, 0.215 mg/0.035, 0.250 mg/0.035 mg, Barr, Prefest (estradiol and norgestimate), King Pharmaceuticals Norgestimate and Ethinyl Tri-Previfem (Norgestimate and Ethinyl Estradiol) Tablets, Andrx Pharmaceuticals Estradiol Tablets, Andrx Pharmaceuticals PREFEST (estradiol/norgestimate) Tablets, King Pharmaceuticals, Labeling Revision | Estradiol and Estradiol/Norgestimate Tablets, Barr Labs, Tentative Approval | Estradiol & Estradiol/Norgestimate Tablets, Barr Labs, Approval | Ortho Tri-Cyclen (norgestimate/ethinyl estradiol) Tablets, Ortho-McNeil Pharma, Approval | Norgestimate & Ethinyl Estradiol Tablets, Watson Labs, Approval | Ortho-Cyclen (norgestimate/ethinyl estradiol) Tablets, Johnson & Johnson, Labeling Revision | Ortho Tri-Cyclen (norgestimate/ethinyl estradiol) Tablets, Johnson & Johnson, Labeling Revision | ORTHO-CYCLEN (norgestimate and ethinyl estradiol) Tablets, Johnson & Johnson Pharmaceutical Research & Development, LLC, Formulation Revision | ORTHO TRI-CYCLEN (norgestimate and ethinyl estradiol) Tablets, Johnson & Johnson Pharmaceutical Research & Development, LLC, Formulation Revision | Tri Lo Sprintec (norgestimate and ethinyl estradiol) Tablets, Barr Laboratories, Inc., Approval | Norgestimate and Ethinyl Estradiol Tablets, Watson Laboratories, Inc., Tentative Approval | Norgestimate and Ethinyl Estradiol Tablets, Watson Laboratories, Inc., Approval
  
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