Content specific to this active ingredient… Drug Information Prescribing and patient information from leading authorities Drug Master Files Type 2 master files on file at the FDA Drug Recalls For prescription drugs containing this active ingredient Exclusivity Patent and market exclusivity data Federal Register FR search results for this API FDA Approved Labelling Information found in this drug's package inserts Research Links Chemical identification and research citations Title 21 Code of Federal Regulations FDA regulations for this API

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 ^ FDA's latest approval appears at the bottom of this list. ^   A | B | C | D | E | F | G | H | I | J | K | L | M | N | O | P | Q | R | S | T | U-Z Health Topics | News Feed for each API | DMF Index | Pharma Job Search | Pharma Company News © 2008 Betterchem.com