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FDA Approval Activities for this Drug…
Tramadol Hydrochloride Tablets, 50 mg, Mutual Pharmaceutical Co. ANDA 76-100 6/20/02 6/27/02 7/2/02 | Tramadol Hydrochloride Tablets, 50 mg, Corepharma ANDA 76-003 6/20/02 6/27/02 7/2/02 | Tramadol Hydrochloride Tablets, 50 mg, Mylan ANDA 75-986 6/21/02 6/27/02 7/2/02 | Tramadol Hydrochloride Tablets, 50 mg, Mallinckrodt ANDA 75-983 6/25/02 6/27/02 7/2/02 | Tramadol Hydrochloride Tablets, 50 mg, Sidmak , ANDA 75-982 7/1/02 | Tramadol Hydrochloride Tablets, 50 mg, Torpharm ANDA 75-981 7/10/02 | Tramadol Hydrochloride Tablets, 50 mg, Alphapharm Pty. Ltd. ANDA 75-980 11/21/02 | Tramadol Hydrochloride Tablets, 50 mg, Teva ANDA 75-977 6/19/02 6/27/02 7/2/02 | Tramadol Hydrochloride Tablets, 50 mg, Asta Medica, ANDA 75-974 7/12/02 | Tramadol Hydrochloride Tablets, 50 mg, Eon Labs, ANDA 75-968 6/25/02 6/27/02 7/2/02 | Tramadol Hydrochloride Tablets, 50 mg, Caraco Pharmaceutical , Ltd. ANDA 75-964 6/19/02 6/27/02 7/2/02 | Tramadol Hydrochloride Tablets, 50 mg, Watson, ANDA 75-962 6/24/02 6/27/02 7/2/02 | Tramadol Hydrochloride Tablets, 50 mg, Purepac Pharmaceutical Co. ANDA 75-960 Ultracet (Tramadol & Acetaminophen) Tablets, 37.5 mg & 325 mg, R. W. Johnson Pharmaceutical Research Institute NDA 21-123 Ultram (tramadol hydrochloride), 50 mg and 100 mg tablets R.W. Johnson Pharmaceutical NDA: 20-281/S-029 8/15/01 4/22/03 | Ultram (tramadol hydrochloride), 50 mg and 100 mg tablets R.W. Johnson Pharmaceutical NDA: 20-281/S-016 12/23/99 1/3/00 1/3/00 | Ultram Indication:Management of moderate to moderately severe pain | Ultram (tramadol hydrochloride), 50 mg and 100 mg tablets R.W. Johnson Pharmaceutical NDA: 20-281/S-015 8/21/98 8/8/03 | Ultram (tramadol hydrochloride), 50 mg and 100 mg tablets R.W. Johnson Pharmaceutical NDA: 20-281/S-014 ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE Tablet; 325MG;37.5MG ULTRACET ORTHO MCNEIL 075980 TRAMADOL HYDROCHLORIDE Tablet; 50MG ***SEE 23RD ANNUAL OB SECTION 1.8 DESCRIPTION OF SPECIAL SITUATIONS: TRAMADOL HYDROCHLORIDE*** TRAMADOL HCL Alphapharm 075974 TRAMADOL HYDROCHLORIDE Tablet; 50MG ***SEE 23RD ANNUAL OB SECTION 1.8 DESCRIPTION OF SPECIAL SITUATIONS: TRAMADOL HYDROCHLORIDE*** TRAMADOL HCL ASTA | 075964 TRAMADOL HYDROCHLORIDE Tablet; 50MG ***SEE 23RD ANNUAL OB SECTION 1.8 DESCRIPTION OF SPECIAL SITUATIONS: TRAMADOL HYDROCHLORIDE*** TRAMADOL HCL Caraco 076003 TRAMADOL HYDROCHLORIDE Tablet; 50MG ***SEE 23RD ANNUAL OB SECTION 1.8 DESCRIPTION OF SPECIAL SITUATIONS: TRAMADOL HYDROCHLORIDE*** TRAMADOL HCL Corepharma 075968 TRAMADOL HYDROCHLORIDE Tablet; 50MG ***SEE 23RD ANNUAL OB SECTION 1.8 DESCRIPTION OF SPECIAL SITUATIONS: TRAMADOL HYDROCHLORIDE*** TRAMADOL HCL Eon 075963 TRAMADOL HYDROCHLORIDE Tablet; 50MG ***SEE 23RD ANNUAL OB SECTION 1.8 DESCRIPTION OF SPECIAL SITUATIONS: TRAMADOL HYDROCHLORIDE*** TRAMADOL HCL Ivax 075983 TRAMADOL HYDROCHLORIDE Tablet; 50MG ***SEE 23RD ANNUAL OB SECTION 1.8 DESCRIPTION OF SPECIAL SITUATIONS: TRAMADOL HYDROCHLORIDE*** TRAMADOL HCL Mallinckrodt | 076100 TRAMADOL HYDROCHLORIDE Tablet; 50MG ***SEE 23RD ANNUAL OB SECTION 1.8 DESCRIPTION OF SPECIAL SITUATIONS: TRAMADOL HYDROCHLORIDE*** TRAMADOL HCL Mutual 075986 TRAMADOL HYDROCHLORIDE Tablet; 50MG ***SEE 23RD ANNUAL OB SECTION 1.8 DESCRIPTION OF SPECIAL SITUATIONS: TRAMADOL HYDROCHLORIDE*** TRAMADOL HCL Mylan | 020281 TRAMADOL HYDROCHLORIDE Tablet; 50MG ULTRAM ORTHO MCNEIL 075982 TRAMADOL HYDROCHLORIDE Tablet; 50MG ***SEE 23RD ANNUAL OB SECTION 1.8 DESCRIPTION OF SPECIAL SITUATIONS: TRAMADOL HYDROCHLORIDE*** TRAMADOL HCL Pliva | 075960 TRAMADOL HYDROCHLORIDE Tablet; 50MG ***SEE 23RD ANNUAL OB SECTION 1.8 DESCRIPTION OF SPECIAL SITUATIONS: TRAMADOL HYDROCHLORIDE*** TRAMADOL HCL Purepac 075977 TRAMADOL HYDROCHLORIDE Tablet; 50MG ***SEE 23RD ANNUAL OB SECTION 1.8 DESCRIPTION OF SPECIAL SITUATIONS: TRAMADOL HYDROCHLORIDE*** TRAMADOL HCL Teva | 075981 TRAMADOL HYDROCHLORIDE Tablet; 50MG ***SEE 23RD ANNUAL OB SECTION 1.8 DESCRIPTION OF SPECIAL SITUATIONS: TRAMADOL HYDROCHLORIDE*** TRAMADOL HCL Torpharm | 075962 TRAMADOL HYDROCHLORIDE Tablet; 50MG ***SEE 23RD ANNUAL OB SECTION 1.8 DESCRIPTION OF SPECIAL SITUATIONS: TRAMADOL HYDROCHLORIDE*** TRAMADOL HCL Watson Ultram (tramadol hydrochloride) & Ultracet (Acetaminophen/Tramadol Hydrochloride) Tablets, Ortho-McNeil Pharmaceutical | Tramadol Hydrochloride & Acetaminophen Tablet, Kali Labs, Tentative Approval | Tramadol and Acetaminophen, Kali Labs, Approval | Tramadol Hydrochloride & Acetaminophen Tablets, Teva Pharma, Tentative Approval | ULTRAM ER (tramadol hydrochloride) tablet, Biovail Labs, Labeling Revision | Tramadol Hydrochloride and Acetaminophen Tablets, Barr Labs, Approval | Ultram ER (Tramadol Hydrochloride) Tabelt, Biovail Labs, Labeling Revision | Tramadol Hydrochloride and Acetaminophen Tablets, Alphapharm, Tentative Approval | Tramadol Hydrochloride Tablets, Watson Labs, Control Supplement | Ultram ER Extended-Release Tablets, Biovail Labs, Labeling Revision | Tramadol Hydrochloride Tablets, Pliva Inc., Control Supplement | Tramadol Hydrochloride Tablets, Pliva Inc., Facility Addition | Tramadol Hydrochloride Tablets, Pliva Inc., Manufacturing Revision | Tramadol Hydrochloride and Acetaminophen Tablets, Alphapharm Party, Ltd., Approval | Tramadol Hydrochloride and Acetaminophen Tablets, Alphapharm Party, Ltd., Approval | Ryzolt (tramadol hydrochloride) Extended-Release Tablets, Labopharm Canada, Inc., Approval | Tramadol Hydrochloride Extended-Release Capsules, Willcox & Savage, P.C., Tentative Approval | Tramadol Hydrochloride Extended Release Tablets, Par Pharmaceutical, Inc., Tentative Approval | Ultracet (tramadol hydrochlorde and acetaminophen) Tablets, Johnson & Johnson Pharmaceutical Resesarch & Development, L.L.C., Supplement | Tramadol Hydrochloride Extended-Release Tablets, Par Pharmaceutical, Inc., Approval | Tramadol Hydrochloride and Acetaminophen Tablets, Amneal Pharmaceuticals, Approval | Tramadol Hydrochloride Extended-Release Capsules, Wilcox and Savage, Approval | Tramadol Hydrochloride Tablets, Northstar Healthcare Holdings Ltd., Approval | Rybix ODT (tramadol hydrochloride) Orally Disintegrating Tablet, Victory Pharma, Inc., Labeling Revision | Tramadol Hydrochloride Orally Disintegrating Tablets, Victory Pharma, Inc., Labeling Revision | Tramadol Hydrochloride Tablets, Zydus Pharmaceuticals (USA) Inc., Approval | Ultracet (tramadol hydrochloride and acetaminophen) Tablets, Ortho-McNeil-Janssen Pharmaceuticals, Inc., Labeling Revision | Tramadol Hydrochloride Extended-Release Tablets, Par Pharmaceutical, Inc., New Dosage | Tramadol Hydrochloride Extended-Release Tablets, Lupin Ltd., Approval | Tramadol Hydrochloride Extended-Release Tablets, Sun Pharma Global, Tentative Approval | Tramadol Hydrochloride Tablets, Alvogen, Inc., Approval | Tramadol Hydrochloride, tramadol hydrochloride, Tablet, Extended Release; Oral, Sun Pharma Global, Approval
  
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