Drugs@FDA: FDA-Approved Drugs
Biologic License Application (BLA): 103772
Company: CENTOCOR INC
Company: CENTOCOR INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| REMICADE | INFLIXIMAB | 100MG | VIAL | Prescription | None | No | No |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 08/24/1998 | ORIG-1 | Approval | N/A; Orphan |
Label (PDF)
Letter Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/1998/inflcen082498lb.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/inflcen082498L.htm https://web.archive.org/web/20170118085130/https://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/TherapeuticBiologicApplications/ucm093327.htm |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 10/05/2021 | SUPPL-5401 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/103772s5401lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/103772Orig1s5401ltr.pdf | |
| 05/14/2020 | SUPPL-5394 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/103772s5389s5391s5394lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/103772Orig1s5389,s5391,s5394ltr.pdf | |
| 05/14/2020 | SUPPL-5391 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/103772s5389s5391s5394lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/103772Orig1s5389,s5391,s5394ltr.pdf | |
| 05/14/2020 | SUPPL-5389 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/103772s5389s5391s5394lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/103772Orig1s5389,s5391,s5394ltr.pdf | |
| 06/19/2018 | SUPPL-5385 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/103772s5385lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/103772Orig1s5385ltr.pdf | |
| 10/25/2017 | SUPPL-5377 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/103772s5377lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/103772Orig1s05377ltr.pdf | |
| 08/27/2015 | SUPPL-5374 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/103772s5374lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/103772Orig1s5374ltr.pdf | |
| 10/02/2015 | SUPPL-5373 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/103772s5373lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/103772Orig1s5373ltr.pdf | |
| 01/02/2015 | SUPPL-5370 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/103772s5370lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/103772Orig1s5370ltr.pdf | |
| 11/06/2013 | SUPPL-5359 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/103772s5359lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/103772Orig1s5359ltr.pdf | |
| 03/28/2013 | SUPPL-5345 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/103772s5345lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/103772Orig1s5345ltr.pdf | |
| 06/28/2012 | SUPPL-5328 | Supplement |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/103772s5328ltr.pdf |
| 08/01/2011 | SUPPL-5317 | Supplement |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/103772s5317ltr.pdf |
| 09/07/2011 | SUPPL-5314 | Supplement |
Label is not available on this site. |
||
| 09/23/2011 | SUPPL-5301 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/103772s5301lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/103772s5301ltr.pdf | |
| 10/26/2011 | SUPPL-5295 | Supplement |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/103772s5295lbl.pdf | |
| 10/04/2010 | SUPPL-5285 | Supplement |
Label is not available on this site. |
||
| 02/17/2011 | SUPPL-5281 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/103772s5281lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/103772s5281ltr.pdf | |
| 07/29/2010 | SUPPL-5278 | Supplement |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/103772s5278ltr.pdf |
| 04/26/2010 | SUPPL-5260 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/103772s5260lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/103772s5260ltr.pdf | |
| 12/28/2010 | SUPPL-5259 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/103772s5259lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/103772s5259ltr.pdf | |
| 11/18/2009 | SUPPL-5258 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/103772s5258lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/103772s5258ltr.pdf | |
| 05/05/2009 | SUPPL-5234 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/103772s5234lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/103772s5234ltr.pdf | |
| 12/22/2008 | SUPPL-5232 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/103772s5232lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/103772s5232ltr.pdf | |
| 08/06/2008 | SUPPL-5208 | Supplement |
Label is not available on this site. |
||
| 05/19/2008 | SUPPL-5206 | Supplement |
Label is not available on this site. |
||
| 06/12/2007 | SUPPL-5189 | Supplement |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/103772s5189lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/103772s5189ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/103772Orig1s5189Approv.pdf | |
| 08/11/2006 | SUPPL-5167 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/103772s5166, 103772s5167LBL.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/103772s5166s5167ltr.pdf | |
| 08/11/2006 | SUPPL-5166 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/103772s5166, 103772s5167LBL.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/103772s5166s5167ltr.pdf | |
| 12/08/2006 | SUPPL-5163 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/103772s5163lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/103772s5163ltr.pdf | |
| 04/19/2007 | SUPPL-5160 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/103772s5160_LBL.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/103772s5160_LTR.pdf | |
| 10/13/2006 | SUPPL-5145 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/103772s5145LBL.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/103772s5145LTR.pdf | |
| 05/19/2006 | SUPPL-5138 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/103772s5138lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/103772s5138ltr.pdf | |
| 03/17/2006 | SUPPL-5135 | Supplement |
Label is not available on this site. |
||
| 09/26/2006 | SUPPL-5129 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/103772s5129lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/103772s5129ltr.pdf | |
| 09/15/2005 | SUPPL-5113 | Supplement |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/103772s5113lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/103772_5113ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/103772Orig1s5113.pdf | |
| 04/05/2005 | SUPPL-5092 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/103772_5092_LBL.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/103772_5092ltr.pdf | |
| 12/17/2004 | SUPPL-5090 | Supplement |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/103772_5090_ltr.pdf |
| 05/13/2005 | SUPPL-5089 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/103772s5089lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/103772s5089ltr.pdf | |
| 10/07/2004 | SUPPL-5083 | Supplement |
Label is not available on this site. |
||
| 12/17/2004 | SUPPL-5077 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/103772_5077_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/103772_5077_ltr.pdf | |
| 09/29/2004 | SUPPL-5073 | Supplement |
Label (PDF)
Letter (PDF) Patient Package Insert (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/103772s5073lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/103772_5073ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/103772s5073ppi.pdf | |
| 03/10/2004 | SUPPL-5069 | Supplement |
Label is not available on this site. |
||
| 07/29/2004 | SUPPL-5058 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/103772_5058lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/103772_5058ltr.pdf | |
| 09/03/2003 | SUPPL-5056 | Supplement |
Letter (PDF)
Review (PDF) |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/103772-5056ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/103772_S5056_REMIICADE.pdf |
| 07/03/2003 | SUPPL-5049 | Supplement |
Label is not available on this site. |
||
| 07/14/2003 | SUPPL-5047 | Supplement |
Label is not available on this site. |
||
| 04/01/2003 | SUPPL-5032 | Supplement |
Letter
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/inflcen040103L.htm |
| 09/03/2003 | SUPPL-5020 | Supplement |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/103772-5020ltr.pdf |
| 06/28/2002 | SUPPL-5012 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/inflcen062802LB.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/inflcen062802L.pdf | |
| 11/27/2001 | SUPPL-5006 | Supplement |
Label is not available on this site. |
||
| 02/27/2002 | SUPPL-5004 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/inflcen022702LB.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/inflcen022702L.pdf | |
| 12/29/2000 | SUPPL-1007 | Supplement |
Label (PDF)
Letter Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/inflcen122900LB.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/inflcen122900L.htm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/103772_S1007_REMICADE.pdf | |
| 11/10/1999 | SUPPL-1004 | Supplement |
Label (PDF)
Letter Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/inflcen111099lb.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/inflcen111099L.htm https://web.archive.org/web/20170118085130/https://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/TherapeuticBiologicApplications/ucm093335.htm |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 10/05/2021 | SUPPL-5401 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/103772s5401lbl.pdf | |
| 10/05/2021 | SUPPL-5401 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/103772s5401lbl.pdf | |
| 05/14/2020 | SUPPL-5394 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/103772s5389s5391s5394lbl.pdf | |
| 05/14/2020 | SUPPL-5391 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/103772s5389s5391s5394lbl.pdf | |
| 05/14/2020 | SUPPL-5391 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/103772s5389s5391s5394lbl.pdf | |
| 05/14/2020 | SUPPL-5389 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/103772s5389s5391s5394lbl.pdf | |
| 05/14/2020 | SUPPL-5389 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/103772s5389s5391s5394lbl.pdf | |
| 06/19/2018 | SUPPL-5385 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/103772s5385lbl.pdf | |
| 10/25/2017 | SUPPL-5377 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/103772s5377lbl.pdf | |
| 10/02/2015 | SUPPL-5373 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/103772s5373lbl.pdf | |
| 08/27/2015 | SUPPL-5374 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/103772s5374lbl.pdf | |
| 01/02/2015 | SUPPL-5370 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/103772s5370lbl.pdf | |
| 11/06/2013 | SUPPL-5359 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/103772s5359lbl.pdf | |
| 03/28/2013 | SUPPL-5345 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/103772s5345lbl.pdf | |
| 10/26/2011 | SUPPL-5295 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/103772s5295lbl.pdf | |
| 09/23/2011 | SUPPL-5301 | Efficacy | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/103772s5301lbl.pdf | |
| 02/17/2011 | SUPPL-5281 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/103772s5281lbl.pdf | |
| 12/28/2010 | SUPPL-5259 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/103772s5259lbl.pdf | |
| 04/26/2010 | SUPPL-5260 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/103772s5260lbl.pdf | |
| 11/18/2009 | SUPPL-5258 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/103772s5258lbl.pdf | |
| 05/05/2009 | SUPPL-5234 | Supplement | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/103772s5234lbl.pdf | |
| 12/22/2008 | SUPPL-5232 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/103772s5232lbl.pdf | |
| 06/12/2007 | SUPPL-5189 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/103772s5189lbl.pdf | |
| 04/19/2007 | SUPPL-5160 | Efficacy | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/103772s5160_LBL.pdf | |
| 12/08/2006 | SUPPL-5163 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/103772s5163lbl.pdf | |
| 10/13/2006 | SUPPL-5145 | Efficacy | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/103772s5145LBL.pdf | |
| 09/26/2006 | SUPPL-5129 | Efficacy | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/103772s5129lbl.pdf | |
| 08/11/2006 | SUPPL-5167 | Efficacy | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/103772s5166, 103772s5167LBL.pdf | |
| 08/11/2006 | SUPPL-5166 | Efficacy | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/103772s5166, 103772s5167LBL.pdf | |
| 05/19/2006 | SUPPL-5138 | Efficacy | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/103772s5138lbl.pdf | |
| 09/15/2005 | SUPPL-5113 | Efficacy | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/103772s5113lbl.pdf | |
| 05/13/2005 | SUPPL-5089 | Efficacy | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/103772s5089lbl.pdf | |
| 04/05/2005 | SUPPL-5092 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/103772_5092_LBL.pdf | |
| 12/17/2004 | SUPPL-5077 | Efficacy | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/103772_5077_lbl.pdf | |
| 09/29/2004 | SUPPL-5073 | Efficacy | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/103772s5073lbl.pdf | |
| 07/29/2004 | SUPPL-5058 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/103772_5058lbl.pdf | |
| 06/28/2002 | SUPPL-5012 | Efficacy | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/inflcen062802LB.pdf | |
| 02/27/2002 | SUPPL-5004 | Efficacy | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/inflcen022702LB.pdf | |
| 12/29/2000 | SUPPL-1007 | Efficacy | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/inflcen122900LB.pdf | |
| 11/10/1999 | SUPPL-1004 | Efficacy | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/inflcen111099lb.pdf | |
| 08/24/1998 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/1998/inflcen082498lb.pdf |