FDA.reportPublic FDA data

Application 077154

Type
ANDA
Sponsor
SPECGX LLC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001FENTANYL-25FENTANYLFILM, EXTENDED RELEASE;TRANSDERMAL25MCG/HRNoNo
002FENTANYL-50FENTANYLFILM, EXTENDED RELEASE;TRANSDERMAL50MCG/HRNoNo
003FENTANYL-75FENTANYLFILM, EXTENDED RELEASE;TRANSDERMAL75MCG/HRNoNo
004FENTANYL-100FENTANYLFILM, EXTENDED RELEASE;TRANSDERMAL100MCG/HRNoNo
005FENTANYL-12FENTANYLFILM, EXTENDED RELEASE;TRANSDERMAL12.5MCG/HRNoNo
006FENTANYL-37FENTANYLFILM, EXTENDED RELEASE;TRANSDERMAL37.5MCG/HRNoNo
007FENTANYL-62FENTANYLFILM, EXTENDED RELEASE;TRANSDERMAL62.5MCG/HRNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0406-9000FENTANYL TRANSDERMALfentanyl transdermalSpecGx LLCANDACurrent
0406-9000FENTANYL TRANSDERMALfentanyl transdermalSpecGx LLCANDACurrent
0406-9000FENTANYL TRANSDERMAL SYSTEMfentanyl transdermal systemSpecGx LLCANDACurrent
0406-9000FENTANYL TRANSDERMALfentanyl transdermalSpecGx LLCANDACurrent
0406-9000FENTANYL TRANSDERMALfentanyl transdermalSpecGx LLCANDACurrent
0406-9000FENTANYL TRANSDERMALfentanyl transdermalSpecGx LLCANDACurrent
0406-9012FENTANYL TRANSDERMALfentanyl transdermalSpecGx LLCANDACurrent
0406-9012FENTANYL TRANSDERMALfentanyl transdermalSpecGx LLCANDACurrent
0406-9012FENTANYL TRANSDERMALfentanyl transdermalSpecGx LLCANDACurrent
0406-9012FENTANYL TRANSDERMAL SYSTEMfentanyl transdermal systemSpecGx LLCANDACurrent
0406-9012FENTANYL TRANSDERMALfentanyl transdermalSpecGx LLCANDACurrent
0406-9012FENTANYL TRANSDERMALfentanyl transdermalSpecGx LLCANDACurrent
0406-9025FENTANYL TRANSDERMALfentanyl transdermalSpecGx LLCANDACurrent
0406-9025FENTANYL TRANSDERMALfentanyl transdermalSpecGx LLCANDACurrent
0406-9025FENTANYL TRANSDERMAL SYSTEMfentanyl transdermal systemSpecGx LLCANDACurrent
0406-9025FENTANYL TRANSDERMALfentanyl transdermalSpecGx LLCANDACurrent
0406-9025FENTANYL TRANSDERMALfentanyl transdermalSpecGx LLCANDACurrent
0406-9025FENTANYL TRANSDERMALfentanyl transdermalSpecGx LLCANDACurrent
0406-9037FENTANYL TRANSDERMALfentanyl transdermalSpecGx LLCANDACurrent
0406-9037FENTANYL TRANSDERMALfentanyl transdermalSpecGx LLCANDACurrent
0406-9037FENTANYL TRANSDERMALfentanyl transdermalSpecGx LLCANDACurrent
0406-9050FENTANYL TRANSDERMALfentanyl transdermalSpecGx LLCANDACurrent
0406-9050FENTANYL TRANSDERMALfentanyl transdermalSpecGx LLCANDACurrent
0406-9050FENTANYL TRANSDERMALfentanyl transdermalSpecGx LLCANDACurrent
0406-9050FENTANYL TRANSDERMAL SYSTEMfentanyl transdermal systemSpecGx LLCANDACurrent
0406-9050FENTANYL TRANSDERMALfentanyl transdermalSpecGx LLCANDACurrent
0406-9050FENTANYL TRANSDERMALfentanyl transdermalSpecGx LLCANDACurrent
0406-9062FENTANYL TRANSDERMALfentanyl transdermalSpecGx LLCANDACurrent
0406-9062FENTANYL TRANSDERMALfentanyl transdermalSpecGx LLCANDACurrent
0406-9062FENTANYL TRANSDERMALfentanyl transdermalSpecGx LLCANDACurrent
0406-9075FENTANYL TRANSDERMALfentanyl transdermalSpecGx LLCANDACurrent
0406-9075FENTANYL TRANSDERMALfentanyl transdermalSpecGx LLCANDACurrent
0406-9075FENTANYL TRANSDERMALfentanyl transdermalSpecGx LLCANDACurrent
0406-9075FENTANYL TRANSDERMALfentanyl transdermalSpecGx LLCANDACurrent
0406-9075FENTANYL TRANSDERMALfentanyl transdermalSpecGx LLCANDACurrent
0406-9075FENTANYL TRANSDERMAL SYSTEMfentanyl transdermal systemSpecGx LLCANDACurrent
0406-9100FENTANYL TRANSDERMALfentanyl transdermalSpecGx LLCANDACurrent
0406-9100FENTANYL TRANSDERMALfentanyl transdermalSpecGx LLCANDACurrent
0406-9112FENTANYL TRANSDERMALfentanyl transdermalSpecGx LLCANDACurrent
0406-9112FENTANYL TRANSDERMALfentanyl transdermalSpecGx LLCANDACurrent
0406-9125FENTANYL TRANSDERMALfentanyl transdermalSpecGx LLCANDACurrent
0406-9125FENTANYL TRANSDERMALfentanyl transdermalSpecGx LLCANDACurrent
0406-9150FENTANYL TRANSDERMALfentanyl transdermalSpecGx LLCANDACurrent
0406-9150FENTANYL TRANSDERMALfentanyl transdermalSpecGx LLCANDACurrent
0406-9175FENTANYL TRANSDERMALfentanyl transdermalSpecGx LLCANDACurrent
0406-9175FENTANYL TRANSDERMALfentanyl transdermalSpecGx LLCANDACurrent
21695-975FENTANYL TRANSDERMAL SYSTEMfentanyl transdermal systemRebel Distributors CorpANDACurrent
35356-637FENTANYL TRANSDERMAL SYSTEMfentanyl transdermal systemLake Erie Medical DBA Quality Care Products LLCANDACurrent
35356-638FENTANYL TRANSDERMAL SYSTEMfentanyl transdermal systemLake Erie Medical DBA Quality Care Products LLCANDACurrent
35356-638FENTANYL TRANSDERMAL SYSTEMfentanyl transdermal systemLake Erie Medical DBA Quality Care Products LLCANDACurrent
42254-002FENTANYL TRANSDERMAL SYSTEMfentanyl transdermal systemRebel Distributors Corp.ANDACurrent
63629-4764FENTANYL TRANSDERMALfentanyl transdermalBryant Ranch PrepackANDACurrent
63629-4764FENTANYL TRANSDERMAL SYSTEMfentanyl transdermal systemBryant Ranch PrepackANDACurrent
63629-4771FENTANYL TRANSDERMALfentanyl transdermalBryant Ranch PrepackANDACurrent
63629-4771FENTANYL TRANSDERMAL SYSTEMfentanyl transdermalBryant Ranch PrepackANDACurrent
63629-4771FENTANYL TRANSDERMAL SYSTEMfentanyl transdermal systemBryant Ranch PrepackANDACurrent
63629-4773FENTANYL TRANSDERMALfentanyl transdermalBryant Ranch PrepackANDACurrent
63629-4773FENTANYL TRANSDERMAL SYSTEMfentanyl transdermal systemBryant Ranch PrepackANDACurrent
63629-5492FENTANYL TRANSDERMAL SYSTEMfentanyl transdermal systemBryant Ranch PrepackANDACurrent
71335-0683FENTANYL TRANSDERMAL systemfentanyl transdermal systemBryant Ranch PrepackANDACurrent
71335-0683FENTANYL TRANSDERMAL SYSTEMfentanyl transdermal systemBryant Ranch PrepackANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
24060ORIG2015-06-30