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

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