Butorphanol Nasal Spray

Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Mylan Pharmaceuticals Inc. (2013-12-31)
Oldest Current Product
2002-03-12
License(s)
ANDA
RxNORM
NASAL SPRAY\BUTORPHANOL
FDAOB
NASAL\SPRAY, METERED\BUTORPHANOL TARTRATE
SPL Active
NASAL\SOLUTION\BUTORPHANOL TARTRATE
NASAL\SPRAY, METERED\BUTORPHANOL TARTRATE
NASAL\SPRAY\BUTORPHANOL TARTRATE
SPL Moiety
NASAL\SOLUTION\BUTORPHANOL
NASAL\SPRAY, METERED\BUTORPHANOL
NASAL\SPRAY\BUTORPHANOL

product(s) by strength(s)

butorphanol tartrate 10 mg/ml nasal spray

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000543090ANDARoxane Laboratories, Inc2002-03-12BUTORPHANOL TARTRATENASALSPRAY, METEREDANDA0758245a50d22e-acbe-4b15-9ed6-70713378408a
2003789639ANDAMylan Pharmaceuticals Inc.2011-01-21BUTORPHANOL TARTRATENASALSPRAYANDA0757599c069ce5-ea67-4f42-afe4-30b01b4ce24d
3605050813ANDAApotex Corp2002-12-04BUTORPHANOL TARTRATENASALSOLUTIONANDA075499b8e48063-0b40-ee43-85c1-4ef2de80c404

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1545695988ANDAA-S Medication Solutions Llc2002-03-12BUTORPHANOL TARTRATENASALSPRAY, METERED000543090ANDA0758241b22bb27-177a-49a7-a4bc-8e25bcbae32a

application(s)

#idtitledeprecatedapplicantapprovedapproved drug
1ANDA075499BUTORPHANOL TARTRATENOVEX PHARMA2002-12-04ANDA075499_001
2ANDA075759BUTORPHANOL TARTRATEMYLAN PHARMACEUTICALS INC2001-08-08ANDA075759_001
3ANDA075824BUTORPHANOL TARTRATEROXANE LABORATORIES INC2002-03-12ANDA075824_001
4NDA019890STADOLTrueBRISTOL MYERS SQUIBB CO PHARMACEUTICAL RESEARCH INSTITUTE1991-12-12NDA019890_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA075499_001RXBUTORPHANOL TARTRATE (1MG/SPRAY)NASALSPRAY, METEREDFalseAB2002-12-04BUTORPHANOL TARTRATE
2ANDA075759_001RXBUTORPHANOL TARTRATE (1MG/SPRAY)NASALSPRAY, METEREDTrueAB2001-08-08BUTORPHANOL TARTRATE
3ANDA075824_001RXBUTORPHANOL TARTRATE (1MG/SPRAY)NASALSPRAY, METEREDFalseAB2002-03-12BUTORPHANOL TARTRATE
4NDA019890_001discontinuedBUTORPHANOL TARTRATE (1MG/SPRAY)NASALSPRAY, METEREDFalse1991-12-12STADOL

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
11b22bb27-177a-49a7-a4bc-8e25bcbae32a (view SPL)BUTORPHANOL TARTRATE Nasal Spray, 10 mg/mL CIVprescriptionHuman PrescriptionA-S Medication Solutions Llcrelabel2013-06-061545695988
25a50d22e-acbe-4b15-9ed6-70713378408a (view SPL)BUTORPHANOL TARTRATE Nasal Spray USP, 10 mg/mL CIVprescriptionHuman PrescriptionRoxane Laboratories, IncMANUFACTURE2015-08-314000543090
39c069ce5-ea67-4f42-afe4-30b01b4ce24d (view SPL)prescriptionHuman PrescriptionMylan Pharmaceuticals Inc.2013-12-314003789639
4b8e48063-0b40-ee43-85c1-4ef2de80c404 (view SPL)Butorphanol Tartrate Nasal Solution USP, 10 mg/mL CIVprescriptionHuman PrescriptionApotex Corpanalysis, manufacture2012-02-141605050813

Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII