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FDA grants tentative approval for generic Ortho Tri-Cyclen.
2004 FEB 5 - (NewsRx.com & NewsRx.net) -- Andrx Corporation (ADRX) announced that the U.S. Food and Drug Administration (FDA) has tentatively approved the company's Abbreviated New Drug Application (ANDA) for Ortho Tri-Cyclen (norgestimate/ethinyl estradiol) tablets, an Ortho-McNeil Pharmaceutical, Inc., oral contraceptive product.
The Andrx ANDA is for 0.18 mg/0.035 mg, 0.215 mg/0.035 mg, and 0.25 mg/0.035 mg strengths, packaged in 28-day cycle regimens. According to the FDA's letter, pediatric exclusivity was granted for this product, thereby extending the effective expiration date of the patents pertaining to this product until March 26, 2004.
The company has received inquiries regarding the January 7, 2004, update of new drug approvals issued by Center for Drug ...
- Ortho Tri-Cyclen Lo now available by prescription.(Brief Article)
- Magazine article from: Women's Health Weekly December 5, 2002 700+ words
...McNeil Pharmaceutical, Inc. Ortho Tri-Cyclen Lo is a triphasic birth...Norgestimate is unique to Ortho Tri-Cyclen Lo, Ortho Tri-Cyclen, and Ortho-CycleN...article was prepared by Women's Health Weekly editors from staff and other...
- Generic version of Ortho Tri-Cyclen released.
- Magazine article from: Women's Health Weekly January 29, 2004 700+ words
...McNeil Pharmaceutical's Ortho Tri-Cyclen oral contraceptive...s patents protecting Ortho Tri-Cyclen oral contraceptive...contraceptive products." Ortho Tri-Cyclen is a regimen...prepared by Women's Health Weekly editors from staff and...
- New Study Shows Women Experience Significantly Less Unscheduled Bleeding With...
- Magazine article from: Women's Health Weekly May 21, 2009 700+ words
...The birth control pill ORTHO TRI-CYCLEN(R) LO...lend further support to ORTHO TRI-CYCLEN LO as an effective...prepared by Women's Health Weekly editors from staff and...Copyright 2009, Women's Health Weekly via NewsRx.com.
- New Low-Dose Birth Control Pill, ORTHO TRI-CYCLEN(R) LO Now Available By...
- Press release article from: PR Newswire October 14, 2002 700+ words
RARITAN, N.J. -- ORTHO TRI-CYCLEN(R) LO (norgestimate...and Drug Administration (FDA), ORTHO TRI-CYCLEN LO contains a combination...Like other oral contraceptives, ORTHO TRI-CYCLEN LO is highly effective when...
- Report Shows Popular Birth Control Pill, ORTHO TRI-CYCLEN(R) LO, Not Associated...
- Press release article from: PR Newswire May 9, 2006 700+ words
...The popular birth control pill, ORTHO TRI-CYCLEN(R) LO (norgestimate/ethinyl...risk of pregnancy in heavier women using ORTHO TRI-CYCLEN LO. "A significant number...Urology. "These results reinforce ORTHO TRI-CYCLEN LO as an effective birth control...
- New, Low Dose Formulation of Nation's #1 Prescribed Birth Control Pill Approved...
- Press release article from: PR Newswire August 23, 2002 700+ words
...has approved a new oral contraceptive, ORTHO TRI-CYCLEN (R) LO (norgestimate/ethinyl...Tablets for the prevention of pregnancy. ORTHO TRI-CYCLEN LO will be available by prescription...CGF017 ) Like other oral contraceptives, ORTHO TRI-CYCLEN LO, is highly effective when...
- New Study Shows Women Experience Significantly Less Unscheduled Bleeding With...
- Press release article from: PR Newswire May 5, 2009 700+ words
...PRNewswire/ -- The birth control pill ORTHO TRI-CYCLEN(R) LO (norgestimate/ethinyl...kind study lend further support to ORTHO TRI-CYCLEN LO as an effective birth control...The OC regimens evaluated were 21-day ORTHO TRI-CYCLEN LO and 24-day YAZ. The primary...
- Ortho Tri-Cyclen Lo now available by prescription.
- Newspaper article from: Drug Week December 6, 2002 700+ words
...NewsRx.com & NewsRx.net) -- Ortho Tri-Cyclen Lo (norgestimate/ethinyl...Food and Drug Administration (FDA), Ortho Tri-Cyclen Lo contains a combination of...norgestimate. Like other oral contraceptives, Ortho Tri-Cyclen Lo is highly effective when...
