Documents
Application Sponsors
| BLA 103471 | BAYER HEALTHCARE PHARMS | |
Marketing Status
Application Products
| 001 | VIAL; SUBCUTANEOUS | 0.3 MG | 0 | BETASERON | INTERFERON BETA-1B |
FDA Submissions
| TYPE 1; Type 1 - New Molecular Entity | ORIG | 1 | AP | 1993-07-23 | PRIORITY |
| EFFICACY; Efficacy | SUPPL | 1039 | AP | 2003-03-14 | PRIORITY |
| S; Supplement | SUPPL | 5032 | AP | 2003-10-10 | |
| S; Supplement | SUPPL | 5060 | AP | 2005-06-08 | |
| LABELING; Labeling | SUPPL | 5063 | AP | 2012-12-11 | STANDARD |
| S; Supplement | SUPPL | 5065 | AP | 2005-07-28 | |
| S; Supplement | SUPPL | 5066 | AP | 2005-07-28 | |
| LABELING; Labeling | SUPPL | 5067 | AP | 2012-12-11 | |
| S; Supplement | SUPPL | 5069 | AP | 2005-12-07 | |
| S; Supplement | SUPPL | 5071 | AP | 2005-12-29 | |
| S; Supplement | SUPPL | 5075 | AP | 2005-12-29 | |
| LABELING; Labeling | SUPPL | 5079 | AP | 2012-12-11 | |
| EFFICACY; Efficacy | SUPPL | 5081 | AP | 2006-10-20 | STANDARD |
| S; Supplement | SUPPL | 5082 | AP | 2006-04-04 | |
| S; Supplement | SUPPL | 5084 | AP | 2007-04-26 | |
| S; Supplement | SUPPL | 5085 | AP | 2006-11-09 | |
| LABELING; Labeling | SUPPL | 5088 | AP | 2012-12-11 | |
| S; Supplement | SUPPL | 5097 | AP | 2007-07-18 | |
| LABELING; Labeling | SUPPL | 5120 | AP | 2012-12-11 | STANDARD |
| S; Supplement | SUPPL | 5121 | AP | 2008-09-08 | |
| LABELING; Labeling | SUPPL | 5124 | AP | 2012-12-11 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 5125 | AP | 2013-06-28 | |
| S; Supplement | SUPPL | 5132 | AP | 2009-03-26 | |
| LABELING; Labeling | SUPPL | 5136 | AP | 2012-12-11 | STANDARD |
| LABELING; Labeling | SUPPL | 5138 | AP | 2012-12-11 | STANDARD |
| LABELING; Labeling | SUPPL | 5157 | AP | 2016-04-19 | |
| LABELING; Labeling | SUPPL | 5185 | AP | 2014-01-28 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 5186 | AP | 2015-09-25 | STANDARD |
| LABELING; Labeling | SUPPL | 5187 | AP | 2016-04-19 | STANDARD |
| LABELING; Labeling | SUPPL | 5188 | AP | 2015-12-22 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 5189 | AP | 2017-05-26 | STANDARD |
| LABELING; Labeling | SUPPL | 5191 | AP | 2018-06-08 | STANDARD |
| LABELING; Labeling | SUPPL | 5193 | AP | 2018-08-31 | STANDARD |
| LABELING; Labeling | SUPPL | 5195 | AP | 2019-08-16 | STANDARD |
| LABELING; Labeling | SUPPL | 5197 | AP | 2020-10-01 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 5199 | TA | 2020-11-20 | N/A |
| LABELING; Labeling | SUPPL | 5200 | AP | 2021-11-03 | STANDARD |
| LABELING; Labeling | SUPPL | 5201 | AP | 2022-09-02 | STANDARD |
Submissions Property Types
| ORIG | 1 | Null | 27 |
| SUPPL | 1039 | Orphan | 5 |
| SUPPL | 5032 | Null | 0 |
| SUPPL | 5060 | Null | 0 |
| SUPPL | 5065 | Null | 0 |
| SUPPL | 5066 | Null | 0 |
| SUPPL | 5067 | Null | 0 |
| SUPPL | 5069 | Null | 0 |
| SUPPL | 5071 | Null | 0 |
| SUPPL | 5075 | Null | 0 |
| SUPPL | 5079 | Null | 0 |
| SUPPL | 5082 | Null | 0 |
| SUPPL | 5084 | Null | 0 |
| SUPPL | 5085 | Null | 0 |
| SUPPL | 5088 | Null | 0 |
| SUPPL | 5097 | Null | 0 |
| SUPPL | 5121 | Null | 0 |
| SUPPL | 5125 | Null | 0 |
| SUPPL | 5132 | Null | 0 |
| SUPPL | 5157 | Null | 0 |
| SUPPL | 5186 | Null | 7 |
| SUPPL | 5187 | Null | 7 |
| SUPPL | 5188 | Null | 15 |
| SUPPL | 5189 | Null | 6 |
| SUPPL | 5191 | Null | 6 |
| SUPPL | 5193 | Null | 15 |
| SUPPL | 5195 | Null | 7 |
| SUPPL | 5197 | Null | 7 |
| SUPPL | 5200 | Null | 6 |
| SUPPL | 5201 | Null | 6 |
CDER Filings
BAYER HEALTHCARE PHARMS
cder:Array
(
[0] => Array
(
[ApplNo] => 103471
[companyName] => BAYER HEALTHCARE PHARMS
[docInserts] => ["Medication Guide","https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2018\/103471s5193lbl.pdf#page=18"]
[products] => [{"drugName":"BETASERON","activeIngredients":"INTERFERON BETA-1B","strength":"0.3 MG","dosageForm":"VIAL; SUBCUTANEOUS","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
[labels] => [{"actionDate":"08\/16\/2019","submission":"SUPPL-5195","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/103471s5195lbl.pdf\"}]","notes":""},{"actionDate":"08\/31\/2018","submission":"SUPPL-5193","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/103471s5193lbl.pdf\"}]","notes":""},{"actionDate":"04\/19\/2016","submission":"SUPPL-5187","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/103471s5157lbl.pdf\"}]","notes":""},{"actionDate":"04\/19\/2016","submission":"SUPPL-5187","supplementCategories":"Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/103471s5157lbl.pdf\"}]","notes":""},{"actionDate":"12\/22\/2015","submission":"SUPPL-5188","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/103471s5188lbl.pdf\"}]","notes":""},{"actionDate":"09\/25\/2015","submission":"SUPPL-5186","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/103471s5186lbl.pdf\"}]","notes":""},{"actionDate":"01\/28\/2014","submission":"SUPPL-5185","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/103471s5185lbl.pdf\"}]","notes":""},{"actionDate":"06\/28\/2013","submission":"SUPPL-5125","supplementCategories":"Manufacturing (CMC)","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/103471s5125lbl.pdf\"}]","notes":"This supplement type does not usually require new labeling."},{"actionDate":"12\/11\/2012","submission":"SUPPL-5138","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/103471s5063s5067s5079s5088s5120s5124s5136s5138lbl.pdf\"}]","notes":""},{"actionDate":"12\/11\/2012","submission":"SUPPL-5136","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/103471s5063s5067s5079s5088s5120s5124s5136s5138lbl.pdf\"}]","notes":""},{"actionDate":"12\/11\/2012","submission":"SUPPL-5124","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/103471s5063s5067s5079s5088s5120s5124s5136s5138lbl.pdf\"}]","notes":""},{"actionDate":"12\/11\/2012","submission":"SUPPL-5120","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/103471s5063s5067s5079s5088s5120s5124s5136s5138lbl.pdf\"}]","notes":""},{"actionDate":"12\/11\/2012","submission":"SUPPL-5088","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/103471s5063s5067s5079s5088s5120s5124s5136s5138lbl.pdf\"}]","notes":""},{"actionDate":"12\/11\/2012","submission":"SUPPL-5079","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/103471s5063s5067s5079s5088s5120s5124s5136s5138lbl.pdf\"}]","notes":""},{"actionDate":"12\/11\/2012","submission":"SUPPL-5067","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/103471s5063s5067s5079s5088s5120s5124s5136s5138lbl.pdf\"}]","notes":""},{"actionDate":"12\/11\/2012","submission":"SUPPL-5063","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/103471s5063s5067s5079s5088s5120s5124s5136s5138lbl.pdf\"}]","notes":""},{"actionDate":"10\/10\/2003","submission":"SUPPL-5032","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2003\\\/103471s5032lbl.pdf\"}]","notes":""},{"actionDate":"03\/14\/2003","submission":"SUPPL-1039","supplementCategories":"Efficacy","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2003\\\/ifnbchi031403LB.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"07\/23\/1993","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"N\/A; Orphan","inserts":"[{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/pre96\\\/103471s0000TOC.cfm\"}]","notes":"> Label is not available on this site."}]
[supplements] => [{"actionDate":"08\/16\/2019","submission":"SUPPL-5195","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/103471s5195lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/103471Orig1s5195ltr.pdf\"}]","notes":">"},{"actionDate":"08\/31\/2018","submission":"SUPPL-5193","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/103471s5193lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/103471Orig1s5193ltr.pdf\"}]","notes":">"},{"actionDate":"06\/08\/2018","submission":"SUPPL-5191","supplementCategories":"Supplement","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/103471Orig1s5191ltr.pdf\"}]","notes":"> Label is not available on this site."},{"actionDate":"05\/26\/2017","submission":"SUPPL-5189","supplementCategories":"Supplement","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/103471Orig1s5189ltr.pdf\"},{\"name\":\"Review (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2017\\\/103471Orig1s5189.pdf\"}]","notes":"> Label is not available on this site."},{"actionDate":"12\/22\/2015","submission":"SUPPL-5188","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/103471s5188lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2015\\\/103471Orig1s5188ltr.pdf\"}]","notes":">"},{"actionDate":"04\/19\/2016","submission":"SUPPL-5187","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/103471s5157lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2016\\\/103471Orig1s5187ltr.pdf\"}]","notes":">"},{"actionDate":"09\/25\/2015","submission":"SUPPL-5186","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/103471s5186lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2015\\\/103471Orig1s5186ltr.pdf\"},{\"name\":\"Review (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2015\\\/103471Orig1s5186.pdf\"}]","notes":">"},{"actionDate":"01\/28\/2014","submission":"SUPPL-5185","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/103471s5185lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2014\\\/103471Orig1s5185ltr.pdf\"}]","notes":">"},{"actionDate":"04\/19\/2016","submission":"SUPPL-5157","supplementCategories":"Supplement","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"12\/11\/2012","submission":"SUPPL-5138","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/103471s5063s5067s5079s5088s5120s5124s5136s5138lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2012\\\/103471Origs5063,s5067,s5079,s5088,s5120,s5124,s5136,s5138ltr.pdf\"}]","notes":">"},{"actionDate":"12\/11\/2012","submission":"SUPPL-5136","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/103471s5063s5067s5079s5088s5120s5124s5136s5138lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2012\\\/103471Origs5063,s5067,s5079,s5088,s5120,s5124,s5136,s5138ltr.pdf\"}]","notes":">"},{"actionDate":"03\/26\/2009","submission":"SUPPL-5132","supplementCategories":"Supplement","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"06\/28\/2013","submission":"SUPPL-5125","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/103471s5125lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2013\\\/103471Orig1s5125ltr.pdf\"}]","notes":">"},{"actionDate":"12\/11\/2012","submission":"SUPPL-5124","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/103471s5063s5067s5079s5088s5120s5124s5136s5138lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2012\\\/103471Origs5063,s5067,s5079,s5088,s5120,s5124,s5136,s5138ltr.pdf\"}]","notes":">"},{"actionDate":"09\/08\/2008","submission":"SUPPL-5121","supplementCategories":"Supplement","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"12\/11\/2012","submission":"SUPPL-5120","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/103471s5063s5067s5079s5088s5120s5124s5136s5138lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2012\\\/103471Origs5063,s5067,s5079,s5088,s5120,s5124,s5136,s5138ltr.pdf\"}]","notes":">"},{"actionDate":"07\/18\/2007","submission":"SUPPL-5097","supplementCategories":"Supplement","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"12\/11\/2012","submission":"SUPPL-5088","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/103471s5063s5067s5079s5088s5120s5124s5136s5138lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2012\\\/103471Origs5063,s5067,s5079,s5088,s5120,s5124,s5136,s5138ltr.pdf\"}]","notes":">"},{"actionDate":"11\/09\/2006","submission":"SUPPL-5085","supplementCategories":"Supplement","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"04\/26\/2007","submission":"SUPPL-5084","supplementCategories":"Supplement","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"04\/04\/2006","submission":"SUPPL-5082","supplementCategories":"Supplement","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"10\/20\/2006","submission":"SUPPL-5081","supplementCategories":"Supplement","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"12\/11\/2012","submission":"SUPPL-5079","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/103471s5063s5067s5079s5088s5120s5124s5136s5138lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2012\\\/103471Origs5063,s5067,s5079,s5088,s5120,s5124,s5136,s5138ltr.pdf\"}]","notes":">"},{"actionDate":"12\/29\/2005","submission":"SUPPL-5075","supplementCategories":"Supplement","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"12\/29\/2005","submission":"SUPPL-5071","supplementCategories":"Supplement","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"12\/07\/2005","submission":"SUPPL-5069","supplementCategories":"Supplement","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"12\/11\/2012","submission":"SUPPL-5067","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/103471s5063s5067s5079s5088s5120s5124s5136s5138lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2012\\\/103471Origs5063,s5067,s5079,s5088,s5120,s5124,s5136,s5138ltr.pdf\"}]","notes":">"},{"actionDate":"07\/28\/2005","submission":"SUPPL-5066","supplementCategories":"Supplement","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"07\/28\/2005","submission":"SUPPL-5065","supplementCategories":"Supplement","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"12\/11\/2012","submission":"SUPPL-5063","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/103471s5063s5067s5079s5088s5120s5124s5136s5138lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2012\\\/103471Origs5063,s5067,s5079,s5088,s5120,s5124,s5136,s5138ltr.pdf\"}]","notes":">"},{"actionDate":"06\/08\/2005","submission":"SUPPL-5060","supplementCategories":"Supplement","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"10\/10\/2003","submission":"SUPPL-5032","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2003\\\/103471s5032lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2003\\\/103471-5032ltr.pdf\"}]","notes":">"},{"actionDate":"03\/14\/2003","submission":"SUPPL-1039","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2003\\\/ifnbchi031403LB.pdf\"},{\"name\":\"Letter\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2003\\\/ifnbchi031403L.htm\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/web.archive.org\\\/web\\\/20170118085127\\\/https:\\\/\\\/www.fda.gov\\\/Drugs\\\/DevelopmentApprovalProcess\\\/HowDrugsareDevelopedandApproved\\\/ApprovalApplications\\\/TherapeuticBiologicApplications\\\/ucm080486.htm\"}]","notes":">"}]
[actionDate] => 2019-08-16
)
)