Propantheline Oral Tablet

Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Roxane Laboratories, Inc (2012-10-18)
Oldest Current Product
1981-12-14
License(s)
ANDA
RxNORM
ORAL TABLET\PROPANTHELINE
FDAOB
ORAL\TABLET\PROPANTHELINE BROMIDE
SPL Active
ORAL\TABLET, FILM COATED\PROPANTHELINE BROMIDE
SPL Moiety
ORAL\TABLET, FILM COATED\PROPANTHELINE

product(s) by strength(s)

propantheline 15 mg oral tablet

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000544721ANDARoxane Laboratories, Inc1981-12-14PROPANTHELINE BROMIDEORALTABLET, FILM COATEDANDA08092784a920c8-b637-4741-b9b2-fc607e245ce0

application(s)

#idtitledeprecatedapplicantapprovedapproved drug
1ANDA080927PROPANTHELINE BROMIDEROXANE LABORATORIES INCANDA080927_001, ANDA080927_002
2ANDA080928PROPANTHELINE BROMIDETrueSANDOZ INCANDA080928_001
3ANDA080977PROPANTHELINE BROMIDETruePRIVATE FORMULATIONS INCANDA080977_001
4ANDA083029PROPANTHELINE BROMIDETrueWATSON LABORATORIES INCANDA083029_002
5ANDA083151PROPANTHELINE BROMIDETrueWATSON LABORATORIES INCANDA083151_001
6ANDA083706PROPANTHELINE BROMIDETrueMYLAN PHARMACEUTICALS INCANDA083706_001
7ANDA084428PROPANTHELINE BROMIDETrueTABLICAPS INCANDA084428_001
8ANDA084541PROPANTHELINE BROMIDETrueIMPAX LABORATORIES INCANDA084541_002
9ANDA085780PROPANTHELINE BROMIDETrueHEATHER DRUG CO INCANDA085780_001
10ANDA087663PROPANTHELINE BROMIDETrueASCOT HOSP PHARMACEUTICALS INC DIV TRAVENOL LABORATORIES INC1982-10-25ANDA087663_001
11ANDA088377PROPANTHELINE BROMIDETruePAR PHARMACEUTICAL INC1983-12-08ANDA088377_001
12NDA008732PRO-BANTHINETrueSHIRE DEVELOPMENT INCNDA008732_002, NDA008732_003

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1ANDA080927_001discontinuedPROPANTHELINE BROMIDE (7.5MG)ORALTABLETFalsePROPANTHELINE BROMIDE
2ANDA080927_002RXPROPANTHELINE BROMIDE (15MG)ORALTABLETTruePROPANTHELINE BROMIDE
3ANDA080928_001discontinuedPROPANTHELINE BROMIDE (15MG)ORALTABLETFalsePROPANTHELINE BROMIDE
4ANDA080977_001discontinuedPROPANTHELINE BROMIDE (15MG)ORALTABLETFalsePROPANTHELINE BROMIDE
5ANDA083029_002discontinuedPROPANTHELINE BROMIDE (15MG)ORALTABLETFalsePROPANTHELINE BROMIDE
6ANDA083151_001discontinuedPROPANTHELINE BROMIDE (15MG)ORALTABLETFalsePROPANTHELINE BROMIDE
7ANDA083706_001discontinuedPROPANTHELINE BROMIDE (15MG)ORALTABLETFalsePROPANTHELINE BROMIDE
8ANDA084428_001discontinuedPROPANTHELINE BROMIDE (15MG)ORALTABLETFalsePROPANTHELINE BROMIDE
9ANDA084541_002discontinuedPROPANTHELINE BROMIDE (15MG)ORALTABLETFalsePROPANTHELINE BROMIDE
10ANDA085780_001discontinuedPROPANTHELINE BROMIDE (15MG)ORALTABLETFalsePROPANTHELINE BROMIDE
11ANDA087663_001discontinuedPROPANTHELINE BROMIDE (15MG)ORALTABLETFalse1982-10-25PROPANTHELINE BROMIDE
12ANDA088377_001discontinuedPROPANTHELINE BROMIDE (15MG)ORALTABLETFalse1983-12-08PROPANTHELINE BROMIDE
13NDA008732_002discontinuedPROPANTHELINE BROMIDE (15MG)ORALTABLETFalsePRO-BANTHINE
14NDA008732_003discontinuedPROPANTHELINE BROMIDE (7.5MG)ORALTABLETFalsePRO-BANTHINE

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
184a920c8-b637-4741-b9b2-fc607e245ce0 (view SPL)PROPANTHELINE BROMIDE Tablets USPprescriptionHuman PrescriptionRoxane Laboratories, IncAPI MANUFACTURE, MANUFACTURE2012-10-182000544721

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