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FDA Approval Activities for this Drug…
Oxycodone Hydrochloride Extended-Release Tablets, 80 mg, Impax ANDA 76-318 9/4/03 Oxycodone Hydrochloride Extended-Release Tablets, 80 mg, Teva ANDA 76-168 9/29/03 Oxycodone Hydrochloride, 10, 20, 40 80 mg, Endo ANDA 75-923 7/31/02 Oxycodone and Acetaminophen Capsules, 5 mg/500 mg, Barr ANDA 40-304 10/2/00 10/30/00 Oxycodone and Acetaminophen Capsules, 5 mg/500 mg, Amide ANDA 40-199 12/30/98 8/1/03 Oxycodone and Acetaminophen Capsules USP,5 mg/500 mg. Endo ANDA 40-303 12/30/99 1/3/00 8/4/03 Oxycodone and Acetaminophen Capsules, 5 mg/500 mg, Mallinckrodt Chemical ANDA 40-257 8/4/98 8/5/98 8/4/03 Oxycodone and Acetaminophen Tablets USP, 7.5 mg/500 mg & 10 mg/650, Watson, ANDA 40-371 12/29/00 2/27/01 1/17/02 Oxycodone and Acetaminophen Tablets USP, 7.5 mg/500 mg & 10 mg/650, Endo ANDA 40-341 7/26/99 7/29/99 1/17/02 Oxycodone & Acetaminophen Tablets USP, 2.5mg/325mg & 5mg/325mg. Endo ANDA 40-330 6/25/99 6/28/99 1/17/02 Oxycodone and Acetaminophen Tablets, 5 mg/500 mg Duramed ANDA 40-289 3/16/99 3/22/99 Oxycodone and Acetaminophen Tablets, 5 mg/325 mg, Duramed ANDA 40-272 6/30/98 7/1/98 3/16/99 Oxycodone and Aspirin Tablets USP, 4.5 mg/0.38 mg/325 mg Halsey Drug Co ANDA 40-260 7/17/98 7/17/98 Oxycodone and Aspirin Tablets USP, 4.5 mg/0.38 mg/325 mg Watson, ANDA 40-255 2/27/98 2/22/99 Oxycodone and Acetaminophen Tablets, 5 mg/500 mg Halsey Drug Co. ANDA 40-219 1/22/98 Oxycodone and Acetaminophen Tablets, 5 mg/325 mg Amide Pharmaceutical, ANDA 40-203 3/15/99 3/22/99 9/19/02 Oxycontin (oxycodone HCl) Controlled Release Tablets Purdue Pharma L. P. NDA 20-553/S-01, 02, 04, & 06 3/15/00 4/9/02 Oxycontin (oxycodone HCl) Controlled Release Tablets Purdue Pharma L. P. NDA 20-553/S-024 1/15/02 2/7/02 2/7/02 Oxycontin (Oxycodone Hydrochloride) Tablets, 10, 20, 40, 80, & 160 mg, Purdue Pharma L. P. NDA 20-553/S022 Percocet (Oxycodone Hydrochloride and Acetaminophen) Tablets USP, 7.5 mg/325 mg & 10 mg/325 mg, Endo ANDA 40-434 Roxicodone Tablets, 15 mg and 30 mg, Roxane NDA 21-011 8/31/00 9/11/00 9/11/00 Roxicodone (oxycodone hydrochloride) Sustained Release Tablets, 10 mg and 30 mg, Roxane NDA 20-932 10/26/98 10/28/98 7/8/99 Roxicodone Indication: Indication is for the management of moderate-to-severe pain where use of an opioid analgesic is appropriate for more than a few days. Oxycontin (oxycodone HCl) Controlled Release Tablets, Purdue Pharma L. P. Oxycodone Hydrochloride Extended-Release Tablets, Impax Laboratories, Oxycodone Hydrochloride Tablets, Amide Pharmaceutica Oxycodone Extended-Release Tablets, Endo Pharmaceuticals Oxycodone Extended-Release Tablets, Teva Pharmaceutical PERCODAN/PERCODAN-Demi (Oxycodone and Aspirin) Tablets, Endo Pharmaceuticals Oxycodone and Acetaminophen, Mallinckrodt, Inc., Approval Oxycodone and Acetaminophen, Mallinckrodt, Inc., Approval Oxycodone Hydrochloride and Acetaminophen, Mallinckrodt, Inc., Approval | Oxycodone Hydrochloride Extended-Release Tablet, Impax Labs, Approval | Oxycodone Hydrochloride Extended-Release Tablet(80mg), Endo Pharma, Approval | Combunox (Oxycodone HCl and Ibuprofen) Tablets, Forest Laboratories, Approval | Oxycodone Hydrochloride ER Tablets, Teva Pharmaceuticals, Approval | Oxycodone Hydrochloride Extended Release Tablets, IMPAX Labs, Approval | Oxycodone Hydrochloride Extended Release Tablets, TEVA Pharma, Approval | Oxycodone Hydrochloride Tablets, KV Pharma, Approval | Oxycodone and Acetaminophen Tablets, Mikart, Approval | Combunox (oxycodone HCl and ibuprofen) Tablets, Forest Labs, Labeling Revision | Oxycodone and Acetaminophen Tablets, Mikart, Approval | Oxycodone and Acetaminophen Tablets, Mikart, Inc., Approval | Percodan Tablets (Oxycodone and Aspirin Tablets, USP), Endo Pharma, Formulation Revision | OxyContin (oxycodone HCl controlled-release) Tablets, Purdue Pharma, Control Supplement | Oxycodone Hydrochloride & Acetaminophen Oral Solution, Tyco Healthcare, Approval | Percocet (Acetaminophen; Oxycodone Hydrochloride), Tablet; Oral, Endo Pharmaceuticals, Labeling Revision | Percocet (Acetaminophen; Oxycodone Hydrochloride), Tablet; Oral, Endo Pharmaceuticals, Labeling Revision | Percocet (Acetaminophen; Oxycodone Hydrochloride), Tablet; Oral, Endo Pharmaceuticals, Labeling Revision | Oxycodone Hydrochloride Tablets, Vintage Pharma, Approval
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