Fluphenazine Oral Solution

Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Pharmaceutical Associates, Inc. (2010-09-09)
Oldest Current Product
2010-08-31
License(s)
ANDA
RxNORM
ORAL SOLUTION\FLUPHENAZINE
FDAOB
ORAL\CAPSULE\ACETAMINOPHEN: OXYCODONE HYDROCHLORIDE
ORAL\CONCENTRATE\FLUPHENAZINE HYDROCHLORIDE
SPL Active
ORAL\ELIXIR\FLUPHENAZINE HYDROCHLORIDE
ORAL\SOLUTION, CONCENTRATE\FLUPHENAZINE HYDROCHLORIDE
SPL Moiety
ORAL\ELIXIR\FLUPHENAZINE
ORAL\SOLUTION, CONCENTRATE\FLUPHENAZINE

product(s) by strength(s)

invalid application product(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1001210654ANDAPharmaceutical Associates, Inc.2010-08-31FLUPHENAZINE HYDROCHLORIDEORALELIXIRANDA040106f0a89d5d-01db-47f3-a873-33ab49c6e4f8

fluphenazine hydrochloride 5 mg/ml oral solution

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1001210653ANDAPharmaceutical Associates, Inc.2010-09-01FLUPHENAZINE HYDROCHLORIDEORALSOLUTION, CONCENTRATEANDA0747250860b3f3-3116-40f8-bcb0-e5c47731bdc8

application(s)

#idtitledeprecatedapplicantapprovedapproved drugin other drug docs
1ANDA040061ROXILOXTrueROXANE LABORATORIES INC1995-07-03ANDA040061_001Acetaminophen / Oxycodone Oral Capsule
2ANDA040106OXYCODONE AND ACETAMINOPHENTrueVINTAGE PHARMACEUTICALS INC1996-07-30ANDA040106_001Acetaminophen / Oxycodone Oral Capsule
3ANDA040199OXYCODONE AND ACETAMINOPHENTrueACTAVIS ELIZABETH LLC1998-12-30ANDA040199_001Acetaminophen / Oxycodone Oral Capsule
4ANDA040219OXYCODONE AND ACETAMINOPHENTrueMUTUAL PHARMACEUTICAL CO INC1998-01-22ANDA040219_001Acetaminophen / Oxycodone Oral Capsule
5ANDA040234OXYCODONE AND ACETAMINOPHENTrueWATSON LABORATORIES INC1997-10-30ANDA040234_001Acetaminophen / Oxycodone Oral Capsule
6ANDA040257OXYCODONE AND ACETAMINOPHENTrueMALLINCKRODT CHEMICAL INC1998-08-04ANDA040257_001Acetaminophen / Oxycodone Oral Capsule
7ANDA040289OXYCODONE AND ACETAMINOPHENTrueDURAMED PHARMACEUTICALS INC SUB BARR LABORATORIES INC1999-03-16ANDA040289_001Acetaminophen / Oxycodone Oral Capsule
8ANDA040303OXYCODONE AND ACETAMINOPHENTrueVINTAGE PHARMACEUTICALS LLC1999-12-30ANDA040303_001Acetaminophen / Oxycodone Oral Capsule
9ANDA040304OXYCODONE AND ACETAMINOPHENTrueBARR LABORATORIES INC2000-10-02ANDA040304_001Acetaminophen / Oxycodone Oral Capsule
10ANDA070533PROLIXINTrueAPOTHECON INC DIV BRISTOL MYERS SQUIBB1985-11-07ANDA070533_001
11ANDA073058FLUPHENAZINE HYDROCHLORIDETrueTEVA PHARMACEUTICALS USA1991-08-30ANDA073058_001
12ANDA074725FLUPHENAZINE HYDROCHLORIDEPHARMACEUTICAL ASSOC INC DIV BEACH PRODUCTS1996-09-16ANDA074725_001
13ANDA088246TYLOX-325TrueORTHO MCNEIL PHARMACEUTICAL INC1984-11-08ANDA088246_001Acetaminophen / Oxycodone Oral Capsule
14ANDA088790TYLOXTrueJANSSEN PHARMACEUTICALS INC1984-12-12ANDA088790_001Acetaminophen / Oxycodone Oral Capsule
15ANDA089994OXYCODONE AND ACETAMINOPHENTrueHALSEY DRUG CO INC1989-05-04ANDA089994_001Acetaminophen / Oxycodone Oral Capsule
16NDA016008PERMITILTrueSCHERING CORP SUB SCHERING PLOUGH CORPNDA016008_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1ANDA040061_001discontinuedOXYCODONE HYDROCHLORIDE (5MG), ACETAMINOPHEN (500MG)ORALCAPSULEFalse1995-07-03ROXILOX
2ANDA040106_001discontinuedACETAMINOPHEN (500MG), OXYCODONE HYDROCHLORIDE (5MG)ORALCAPSULEFalse1996-07-30OXYCODONE AND ACETAMINOPHEN
3ANDA040199_001discontinuedOXYCODONE HYDROCHLORIDE (5MG), ACETAMINOPHEN (500MG)ORALCAPSULEFalse1998-12-30OXYCODONE AND ACETAMINOPHEN
4ANDA040219_001discontinuedACETAMINOPHEN (500MG), OXYCODONE HYDROCHLORIDE (5MG)ORALCAPSULEFalse1998-01-22OXYCODONE AND ACETAMINOPHEN
5ANDA040234_001discontinuedOXYCODONE HYDROCHLORIDE (5MG), ACETAMINOPHEN (500MG)ORALCAPSULEFalse1997-10-30OXYCODONE AND ACETAMINOPHEN
6ANDA040257_001discontinuedOXYCODONE HYDROCHLORIDE (5MG), ACETAMINOPHEN (500MG)ORALCAPSULEFalse1998-08-04OXYCODONE AND ACETAMINOPHEN
7ANDA040289_001discontinuedACETAMINOPHEN (500MG), OXYCODONE HYDROCHLORIDE (5MG)ORALCAPSULEFalse1999-03-16OXYCODONE AND ACETAMINOPHEN
8ANDA040303_001discontinuedOXYCODONE HYDROCHLORIDE (5MG), ACETAMINOPHEN (500MG)ORALCAPSULEFalse1999-12-30OXYCODONE AND ACETAMINOPHEN
9ANDA040304_001discontinuedOXYCODONE HYDROCHLORIDE (5MG), ACETAMINOPHEN (500MG)ORALCAPSULEFalse2000-10-02OXYCODONE AND ACETAMINOPHEN
10ANDA070533_001discontinuedFLUPHENAZINE HYDROCHLORIDE (5MG/ML)ORALCONCENTRATEFalse1985-11-07PROLIXIN
11ANDA073058_001discontinuedFLUPHENAZINE HYDROCHLORIDE (5MG/ML)ORALCONCENTRATEFalse1991-08-30FLUPHENAZINE HYDROCHLORIDE
12ANDA074725_001RXFLUPHENAZINE HYDROCHLORIDE (5MG/ML)ORALCONCENTRATETrue1996-09-16FLUPHENAZINE HYDROCHLORIDE
13ANDA088246_001discontinuedOXYCODONE HYDROCHLORIDE (5MG), ACETAMINOPHEN (325MG)ORALCAPSULEFalse1984-11-08TYLOX-325
14ANDA088790_001discontinuedOXYCODONE HYDROCHLORIDE (5MG), ACETAMINOPHEN (500MG)ORALCAPSULEFalse1984-12-12TYLOX
15ANDA089994_001discontinuedOXYCODONE HYDROCHLORIDE (5MG), ACETAMINOPHEN (500MG)ORALCAPSULEFalse1989-05-04OXYCODONE AND ACETAMINOPHEN
16NDA016008_001discontinuedFLUPHENAZINE HYDROCHLORIDE (5MG/ML)ORALCONCENTRATEFalsePERMITIL

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
10860b3f3-3116-40f8-bcb0-e5c47731bdc8 (view SPL)Fluphenazine Hydrochloride Oral Solution USP (Concentrate)prescriptionHuman PrescriptionPharmaceutical Associates, Inc.MANUFACTURE2010-09-093001210653
2f0a89d5d-01db-47f3-a873-33ab49c6e4f8 (view SPL)Fluphenazine Hydrochloride Elixir USPprescriptionHuman PrescriptionPharmaceutical Associates, Inc.MANUFACTURE2010-09-013001210654

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