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... Original Abbreviated Application # 075974 Approval Date: 12-JUL-02 Trade Name: TRAMADOL
HCL Dosage Form: TABLET Applicant: ASTA MEDICA INC Active Ingredient(s ...

... Actiq. 9/9/03. 13. Targeted Surveillance, II. Monitoring of usage data (eg IMS Health
prescription data, ARCOS): Actiq, Suboxone/Subutex, Tramadol. ...

... under 21 CFR 5.10, to request the Commissioner of Food and Drugs to: i) re-evaluate
the prescribing information/package insert for new tramadol formulations in ...

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PDF] 1 US Comments to the Tramadol Critical Review Document Comments ...
1 US Comments to the Tramadol Critical Review Document ... Tramadol is a synthetic,
centrally acting opioid analgesic with a potent active opioid metabolite. ...
www.fda.gov/ohrms/dockets/dockets/05n0479/05N-0479-sup0003-02.pdf - 03-15-2006 - Text Version

[PDF] ULTRACET (tramadol hydrochloride/ acetaminophen tablets) ...
Page 1. ULTRACET (tramadol hydrochloride/ acetaminophen tablets) ... ULTRACET? (37.5
mg tramadol hydrochloride/ 325 mg acetaminophen tablets) combines two ...
www.fda.gov/cder/foi/label/2001/21123lbl.pdf - 05-08-2003 - Text Version

[PDF] Tramadol HCL Tablets 50 Mg Scored NDA 20-281/S-016 ULTRAM ...
Page 1. Tramadol HCL Tablets 50 Mg Scored NDA 20-281/S-016 ... Page 1 C:\TL2\STAGING\
IM3287.DOC/1 ULTRAM ?(tramadol hydrochloride tablets) 1 DESCRIPTION 2 ...
www.fda.gov/cder/foi/label/1999/20281S16LBL.PDF - 01-03-2000 - Text Version
[ More results from www.fda.gov/cder/foi/label ]

[PDF] C:\Data\MY DOCUMENTS\NDAs\J AND J\N20281 ULTRAM\LABELS\040414_ULT ...
NDA 20-281/S-030 Page 1 ULTRAM ?(tramadol hydrochloride tablets) DESCRIPTION ULTRAM ?br> (tramadol hydrochloride tablets) is a centrally acting analgesic. ...
www.fda.gov/medwatch/SAFETY/2004/apr_PI/Ultram_PI.pdf - 06-27-2006 - Text Version

[PDF] C:\Data\MY DOCUMENTS\NDAs\J AND J\N20281 ULTRAM\LABELS\040414_ULT ...
... ULTRACET TM (tramadol hydrochloride/acetaminophen tablets) DESCRIPTION ULTRACET
TM (37.5 mg tramadol hydrochloride/325 mg acetaminophen tablets) combines two ...
www.fda.gov/medwatch/SAFETY/2004/apr_PI/Ultracet_PI.pdf - 06-27-2006 - Text Version
[ More results from www.fda.gov/medwatch/SAFETY/2004 ]

[PDF] Helen Torelli, Esq. . Office of General Counsel Johnson &: Johnson ...
... Administration (FDA) issued a response to three citizen petitions seeking approval
of abbreviated new drug applications (ANDAs) for tramadol hydrochloride 50 ...
www.fda.gov/ohrms/dockets/dailys/03/Apr03/041703/02p-0191-pav0002-vol1.pdf - 05-22-2003 - Text Version

[PDF] AM 3 1 2003
... Administration (FDA) issued a response to three citizen petitions seeking approval
of abbreviated new drug applications (ANDAs) for tramadol hydrochloride 50 ...
www.fda.gov/ohrms/dockets/dailys/03/Apr03/041703/02p-0252-pav0002-vol1.pdf - 05-22-2003 - Text Version
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Drug Approvals for June 2002
... Original Abbreviated Application # 075983 Approval Date: 25-JUN-02 Trade Name: TRAMADOL
HCL Dosage Form: TABLET, FILM COATED Applicant: MALLINCKRODT INC Active ...
www.fda.gov/cder/da/da0602.htm - 01-17-2006 - Cached

ANDA Approvals June 2002
ANDA Approvals June 2002: Table
www.fda.gov/cder/ogd/approvals/ap0602.htm - 04-25-2006 - Cached

Drug Approvals - U
... Ultracet (Tramadol & Acetaminophen) Tablets, 37.5 mg & 325 mg, Rx, RW Johnson
Pharmaceutical Research Institute, NDA 21-123, 8/15/01, 5/9/03, 10/12/01. ...
www.fda.gov/cder/approval/u.htm - 01-06-2006 - Cached

Jacques R. Caldwell, MD Nidpoe Letter
jacques caldwell, MD, nidpoe letter, June 10, 2004
www.fda.gov/foi/nidpoe/n30l.htm - 07-15-2004 - Cached

[PDF] CERTIFIED MAIL RETURN RECEIPT REQUESTED July 20, 2004 Jacques R. ...
... Tramadol (Tramadol and placebo in the treatment of osteoarthritis of the knee.?br> This study of the investigational drug Tramadol was performed for ...
www.fda.gov/foi/nidpoe/n30l.pdf - 08-06-2004 - Text Version

[PDF] and (0
... under 21 CFR 5.10, to request the Commissioner of Food and Drugs to: i) re-evaluate
the prescribing information/package insert for new tramadol formulations in ...
www.fda.gov/ohrms/dockets/dockets/05p0421/05p-0421-cp00001-01-vol1.pdf - 10-31-2005 - Text Version
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[MS POWERPOINT] www.fda.gov/ohrms/dockets/ac/03/slides/3978S1_12_WINCHELL.ppt
... Actiq. 9/9/03. 13. Targeted Surveillance, II. Monitoring of usage data (eg IMS Health
prescription data, ARCOS): Actiq, Suboxone/Subutex, Tramadol. ...
www.fda.gov/ohrms/dockets/ac/03/slides/3978S1_12_WINCHELL.ppt - 11-17-2003 - Text Version

CDER Drug and Biologic Approvals for Calendar Year 2005
... N021693, Tramadol Hydrochloride, Tramadol Hydrochloride, Biovail Labs, 3, S,
05-May-05. ... N021692, Tramadol Hydrochloride, Tramadol Hydrochloride, Biovail, 5, S, ...
www.fda.gov/cder/rdmt/InternetNDA05.htm - Large File: 101k - 04-17-2006 - Cached

CDER Template - Replace Title Here
Replace Description ****************************
www.fda.gov/cder/ogd/approvals/ap0702.htm - 11-07-2000 - Cached
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[PDF] www.fda.gov/cder/warn/2004/12473.pdf
Page 1. Page 2. Page 3.
www.fda.gov/cder/warn/2004/12473.pdf - 11-15-2004 - Text Version

[PDF] Federal Register /Vol. 67, No. 68/Tuesday, April 9, 2002/Notices
... Convention on Narcotic Drugs; Amfepramone (diethylpropion); Amineptine; Buprenorphine;
Delta??tetrahydrocannabinol (dronabinol); Tramadol AGENCY : Food ...
www.fda.gov/ohrms/dockets/98fr/040902a.pdf - 04-09-2002 - Text Version

[Federal Register: April 9, 2002 (Volume 67, Number 68)] [Notices] ...
... Single Convention on Narcotic Drugs; Amfepramone (diethylpropion); Amineptine;
Buprenorphine; Delta-9- tetrahydrocannabinol (dronabinol); Tramadol AGENCY: Food ...
www.fda.gov/ohrms/dockets/98fr/040902a.htm - 04-09-2002 - Cached
[ More results from www.fda.gov/ohrms/dockets/98fr ]

Drug Approvals for July 2002
... Original Abbreviated Application # 075974 Approval Date: 12-JUL-02 Trade Name: TRAMADOL
HCL Dosage Form: TABLET Applicant: ASTA MEDICA INC Active Ingredient(s ...
www.fda.gov/cder/da/da0702.htm - 01-17-2006 - Cached
[ More results from www.fda.gov/cder/da ]

 
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