Propoxyphene Oral Capsule

Category(s)
prescription
SPL Type(s)
Human Prescription
Oldest Current Product
2009-05-01
License(s)
ANDA
RxNORM
ORAL CAPSULE\PROPOXYPHENE
FDAOB
ORAL\CAPSULE\PROPOXYPHENE HYDROCHLORIDE
SPL Active
ORAL\CAPSULE\PROPOXYPHENE HYDROCHLORIDE
SPL Moiety
ORAL\CAPSULE\PROPOXYPHENE

product(s) by strength(s)

invalid application product(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1165900198ANDAStat Rx Usa Llc2009-10-27PROPOXYPHENE HYDROCHLORIDEORALCAPSULE003787065ANDA040569f60e8f65-a12b-4073-ac0f-81e1186617d7
2231550012ANDAHeritage Pharmaceuticals Inc.2009-05-01PROPOXYPHENE HYDROCHLORIDEORALCAPSULEANDA080530a70e9bff-5f9e-43e8-a9ef-6da73bab7d31
3636291359ANDABryant Ranch Prepack2009-12-23PROPOXYPHENE HYDROCHLORIDEORALCAPSULE000930741ANDA08861549c4f24c-648b-2db2-5c00-2835d14b1275

application(s)

#idtitledeprecatedapplicantapprovedapproved drug
1ANDA040569PROPOXYPHENE HYDROCHLORIDETrueMYLAN PHARMACEUTICALS INC2004-12-16ANDA040569_001
2ANDA040908PROPOXYPHENE HYDROCHLORIDETrueVINTAGE PHARMACEUTICALS INC2009-07-17ANDA040908_001
3ANDA080269PROPOXYPHENE HYDROCHLORIDETruePAR PHARMACEUTICAL INCANDA080269_001
4ANDA080530DOLENETrueHERITAGE PHARMACEUTICALS INCANDA080530_001
5ANDA080783PROPOXYPHENE HYDROCHLORIDETrueVALEANT PHARMACEUTICALS INTERNATIONALANDA080783_001
6ANDA080908PROPOXYPHENE HYDROCHLORIDETrueWATSON LABORATORIES INCANDA080908_002
7ANDA083089PROPOXYPHENE HYDROCHLORIDETrueROXANE LABORATORIES INCANDA083089_001, ANDA083089_002
8ANDA083113PROPOXYPHENE HYDROCHLORIDETruePRIVATE FORMULATIONS INCANDA083113_001
9ANDA083125PROPOXYPHENE HYDROCHLORIDETrueSANDOZ INCANDA083125_002
10ANDA083184PROPOXYPHENE HYDROCHLORIDETrueALRA LABORATORIES INCANDA083184_001
11ANDA083185PROPOXYPHENE HYDROCHLORIDETrueNEXGEN PHARMA INCANDA083185_001
12ANDA083186PROPOXYPHENE HYDROCHLORIDETrueMUTUAL PHARMACEUTICAL CO INCANDA083186_001
13ANDA083278PROPOXYPHENE HYDROCHLORIDETruePUREPAC PHARMACEUTICAL COANDA083278_001
14ANDA083299PROPOXYPHENE HYDROCHLORIDETrueMYLAN PHARMACEUTICALS INCANDA083299_001
15ANDA083317PROPOXYPHENE HYDROCHLORIDETrueIMPAX LABORATORIES INCANDA083317_001
16ANDA083464PROPOXYPHENE HYDROCHLORIDETruePRIVATE FORMULATIONS INCANDA083464_001
17ANDA083501PROPOXYPHENE HYDROCHLORIDETrueWEST WARD PHARMACEUTICAL CORPANDA083501_001
18ANDA083528PROPOXYPHENE HYDROCHLORIDETrueMYLAN PHARMACEUTICALS INCANDA083528_001
19ANDA083538PROPHENE 65TrueHALSEY DRUG CO INCANDA083538_002
20ANDA083544KESSO-GESICTrueMK LABORATORIES INCANDA083544_001
21ANDA083597PROPOXYPHENE HYDROCHLORIDETrueIVAX PHARMACEUTICALS INC SUB TEVA PHARMACEUTICALS USAANDA083597_001
22ANDA083688PROPOXYPHENE HYDROCHLORIDETrueSANDOZ INCANDA083688_001
23ANDA083786PROPOXYPHENE HYDROCHLORIDE 65TrueWARNER CHILCOTT DIV WARNER LAMBERT COANDA083786_001
24ANDA083870PROPOXYPHENE HYDROCHLORIDETrueSANDOZ INCANDA083870_002
25ANDA084014PROPOXYPHENE HYDROCHLORIDETrueSANDOZ INCANDA084014_001
26ANDA084551PROPOXYPHENE HYDROCHLORIDETrueWHITEWORTH TOWNE PAULSEN INCANDA084551_001
27ANDA085190PROPOXYPHENE HYDROCHLORIDETrueWATSON LABORATORIES INCANDA085190_001
28ANDA086495PROPOXYPHENE HYDROCHLORIDETrueSANDOZ INCANDA086495_001
29ANDA088615PROPOXYPHENE HYDROCHLORIDETrueTEVA PHARMACEUTICALS USA INC1984-10-22ANDA088615_001
30NDA010997DARVONTrueXANODYNE PHARMACEUTICS INCNDA010997_001, NDA010997_003

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1ANDA040569_001discontinuedPROPOXYPHENE HYDROCHLORIDE (65MG)ORALCAPSULEFalse2004-12-16PROPOXYPHENE HYDROCHLORIDE
2ANDA040908_001discontinuedPROPOXYPHENE HYDROCHLORIDE (65MG)ORALCAPSULEFalse2009-07-17PROPOXYPHENE HYDROCHLORIDE
3ANDA080269_001discontinuedPROPOXYPHENE HYDROCHLORIDE (65MG)ORALCAPSULEFalsePROPOXYPHENE HYDROCHLORIDE
4ANDA080530_001discontinuedPROPOXYPHENE HYDROCHLORIDE (65MG)ORALCAPSULEFalseDOLENE
5ANDA080783_001discontinuedPROPOXYPHENE HYDROCHLORIDE (65MG)ORALCAPSULEFalsePROPOXYPHENE HYDROCHLORIDE
6ANDA080908_002discontinuedPROPOXYPHENE HYDROCHLORIDE (65MG)ORALCAPSULEFalsePROPOXYPHENE HYDROCHLORIDE
7ANDA083089_001discontinuedPROPOXYPHENE HYDROCHLORIDE (32MG)ORALCAPSULEFalsePROPOXYPHENE HYDROCHLORIDE
8ANDA083089_002discontinuedPROPOXYPHENE HYDROCHLORIDE (65MG)ORALCAPSULEFalsePROPOXYPHENE HYDROCHLORIDE
9ANDA083113_001discontinuedPROPOXYPHENE HYDROCHLORIDE (65MG)ORALCAPSULEFalsePROPOXYPHENE HYDROCHLORIDE
10ANDA083125_002discontinuedPROPOXYPHENE HYDROCHLORIDE (65MG)ORALCAPSULEFalsePROPOXYPHENE HYDROCHLORIDE
11ANDA083184_001discontinuedPROPOXYPHENE HYDROCHLORIDE (65MG)ORALCAPSULEFalsePROPOXYPHENE HYDROCHLORIDE
12ANDA083185_001discontinuedPROPOXYPHENE HYDROCHLORIDE (65MG)ORALCAPSULEFalsePROPOXYPHENE HYDROCHLORIDE
13ANDA083186_001discontinuedPROPOXYPHENE HYDROCHLORIDE (65MG)ORALCAPSULEFalsePROPOXYPHENE HYDROCHLORIDE
14ANDA083278_001discontinuedPROPOXYPHENE HYDROCHLORIDE (65MG)ORALCAPSULEFalsePROPOXYPHENE HYDROCHLORIDE
15ANDA083299_001discontinuedPROPOXYPHENE HYDROCHLORIDE (65MG)ORALCAPSULEFalsePROPOXYPHENE HYDROCHLORIDE
16ANDA083317_001discontinuedPROPOXYPHENE HYDROCHLORIDE (65MG)ORALCAPSULEFalsePROPOXYPHENE HYDROCHLORIDE
17ANDA083464_001discontinuedPROPOXYPHENE HYDROCHLORIDE (32MG)ORALCAPSULEFalsePROPOXYPHENE HYDROCHLORIDE
18ANDA083501_001discontinuedPROPOXYPHENE HYDROCHLORIDE (65MG)ORALCAPSULEFalsePROPOXYPHENE HYDROCHLORIDE
19ANDA083528_001discontinuedPROPOXYPHENE HYDROCHLORIDE (32MG)ORALCAPSULEFalsePROPOXYPHENE HYDROCHLORIDE
20ANDA083538_002discontinuedPROPOXYPHENE HYDROCHLORIDE (65MG)ORALCAPSULEFalsePROPHENE 65
21ANDA083544_001discontinuedPROPOXYPHENE HYDROCHLORIDE (65MG)ORALCAPSULEFalseKESSO-GESIC
22ANDA083597_001discontinuedPROPOXYPHENE HYDROCHLORIDE (32MG)ORALCAPSULEFalsePROPOXYPHENE HYDROCHLORIDE
23ANDA083688_001discontinuedPROPOXYPHENE HYDROCHLORIDE (65MG)ORALCAPSULEFalsePROPOXYPHENE HYDROCHLORIDE
24ANDA083786_001discontinuedPROPOXYPHENE HYDROCHLORIDE (65MG)ORALCAPSULEFalsePROPOXYPHENE HYDROCHLORIDE 65
25ANDA083870_002discontinuedPROPOXYPHENE HYDROCHLORIDE (65MG)ORALCAPSULEFalsePROPOXYPHENE HYDROCHLORIDE
26ANDA084014_001discontinuedPROPOXYPHENE HYDROCHLORIDE (32MG)ORALCAPSULEFalsePROPOXYPHENE HYDROCHLORIDE
27ANDA084551_001discontinuedPROPOXYPHENE HYDROCHLORIDE (65MG)ORALCAPSULEFalsePROPOXYPHENE HYDROCHLORIDE
28ANDA085190_001discontinuedPROPOXYPHENE HYDROCHLORIDE (65MG)ORALCAPSULEFalsePROPOXYPHENE HYDROCHLORIDE
29ANDA086495_001discontinuedPROPOXYPHENE HYDROCHLORIDE (65MG)ORALCAPSULEFalsePROPOXYPHENE HYDROCHLORIDE
30ANDA088615_001discontinuedPROPOXYPHENE HYDROCHLORIDE (65MG)ORALCAPSULEFalse1984-10-22PROPOXYPHENE HYDROCHLORIDE
31NDA010997_001discontinuedPROPOXYPHENE HYDROCHLORIDE (32MG)ORALCAPSULEFalseDARVON
32NDA010997_003discontinuedPROPOXYPHENE HYDROCHLORIDE (65MG)ORALCAPSULEFalseDARVON

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
149c4f24c-648b-2db2-5c00-2835d14b1275 (view SPL)PROPOXYPHENE HYDROCHLORIDEprescriptionHuman PrescriptionBryant Ranch PrepackRELABEL, REPACK2012-10-122636291359
2a70e9bff-5f9e-43e8-a9ef-6da73bab7d31 (view SPL)PROPOXYPHENE HYDROCHLORIDE CAPSULES, USP CIV Rx onlyprescriptionHuman PrescriptionHeritage Pharmaceuticals Inc.MANUFACTURE2010-10-011231550012
3f60e8f65-a12b-4073-ac0f-81e1186617d7 (view SPL)InsertprescriptionHuman PrescriptionStat Rx Usa Llc2009-10-271165900198

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