nefazodone Oral Tablet

Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Teva Pharmaceuticals Usa Inc (2014-06-02)
Oldest Current Product
2003-09-16
License(s)
ANDA
RxNORM
ORAL TABLET\NEFAZODONE
FDAOB
ORAL\TABLET\NEFAZODONE HYDROCHLORIDE
SPL Active
ORAL\TABLET\NEFAZODONE HYDROCHLORIDE
SPL Moiety
ORAL\TABLET\NEFAZODONE

product(s) by strength(s)

nefazodone hydrochloride 100 mg oral tablet

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000931024ANDATeva Pharmaceuticals Usa Inc2003-09-16NEFAZODONE HYDROCHLORIDEORALTABLETANDA07603751ff7db5-aaf9-4c3c-86e6-958ebf16b60f

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1165900166ANDAStat Rx Usa Llc2010-08-18NEFAZODONE HYDROCHLORIDEORALTABLET000931024ANDA07603730f2dc3f-a5da-40da-9314-12935cbdac7d
2216950174ANDARebel Distributors Corp2003-09-16NEFAZODONE HYDROCHLORIDEORALTABLET000931024ANDA0760374afee435-ae60-4260-a1df-e52abf7a043d
3493490292ANDARemedyrepack Inc.2011-06-08NEFAZODONE HYDROCHLORIDEORALTABLET000931024ANDA0760371109ac28-47eb-4dc7-8abc-8bc1f19b25eb

nefazodone hydrochloride 150 mg oral tablet

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000937113ANDATeva Pharmaceuticals Usa Inc2003-09-16NEFAZODONE HYDROCHLORIDEORALTABLETANDA07603751ff7db5-aaf9-4c3c-86e6-958ebf16b60f

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1216950175ANDARebel Distributors Corp2003-09-16NEFAZODONE HYDROCHLORIDEORALTABLET000937113ANDA0760374afee435-ae60-4260-a1df-e52abf7a043d

nefazodone hydrochloride 200 mg oral tablet

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000931025ANDATeva Pharmaceuticals Usa Inc2003-09-16NEFAZODONE HYDROCHLORIDEORALTABLETANDA07603751ff7db5-aaf9-4c3c-86e6-958ebf16b60f

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1216950176ANDARebel Distributors Corp2003-09-16NEFAZODONE HYDROCHLORIDEORALTABLET000931025ANDA0760374afee435-ae60-4260-a1df-e52abf7a043d

nefazodone hydrochloride 250 mg oral tablet

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000931026ANDATeva Pharmaceuticals Usa Inc2003-09-16NEFAZODONE HYDROCHLORIDEORALTABLETANDA07603751ff7db5-aaf9-4c3c-86e6-958ebf16b60f

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1216950177ANDARebel Distributors Corp2003-09-16NEFAZODONE HYDROCHLORIDEORALTABLET000931026ANDA0760374afee435-ae60-4260-a1df-e52abf7a043d
2422910627ANDAAvkare, Inc.2013-07-30NEFAZODONE HYDROCHLORIDEORALTABLET000931026ANDA076037916f119c-836f-dbec-45e0-047c0f527925

nefazodone hydrochloride 50 mg oral tablet

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000937178ANDATeva Pharmaceuticals Usa Inc2003-09-16NEFAZODONE HYDROCHLORIDEORALTABLETANDA07603751ff7db5-aaf9-4c3c-86e6-958ebf16b60f

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1422910631ANDAAvkare, Inc.2013-12-16NEFAZODONE HYDROCHLORIDEORALTABLET000937178ANDA076037916f119c-836f-dbec-45e0-047c0f527925

application(s)

#idtitledeprecatedapplicantapprovedapproved drug
1ANDA075763NEFAZODONE HYDROCHLORIDETrueIVAX PHARMACEUTICALS INC SUB TEVA PHARMACEUTICALS USA2003-09-16ANDA075763_001, ANDA075763_002, ANDA075763_003, ANDA075763_004, ANDA075763_005
2ANDA076037NEFAZODONE HYDROCHLORIDETEVA PHARMACEUTICALS USA INC2003-09-16ANDA076037_001, ANDA076037_002, ANDA076037_003, ANDA076037_004, ANDA076037_005
3ANDA076072NEFAZODONE HYDROCHLORIDETrueIDT AUSTRALIA LTD2003-09-16ANDA076072_001, ANDA076072_002, ANDA076072_003, ANDA076072_004, ANDA076072_005
4ANDA076073NEFAZODONE HYDROCHLORIDETrueWATSON LABORATORIES INC2003-09-16ANDA076073_002, ANDA076073_003, ANDA076073_004, ANDA076073_005
5ANDA076129NEFAZODONE HYDROCHLORIDETrueMYLAN PHARMACEUTICALS INC2003-09-16ANDA076129_002, ANDA076129_003, ANDA076129_004, ANDA076129_005
6ANDA076196NEFAZODONE HYDROCHLORIDETrueROXANE LABORATORIES INC2003-09-16ANDA076196_001, ANDA076196_002, ANDA076196_003, ANDA076196_004, ANDA076196_005
7ANDA076302NEFAZODONE HYDROCHLORIDETrueSANDOZ INC2003-09-16ANDA076302_001, ANDA076302_002, ANDA076302_003, ANDA076302_004, ANDA076302_005
8ANDA076309NEFAZODONE HYDROCHLORIDEDR REDDYS LABORATORIES INC2003-09-16ANDA076309_001, ANDA076309_002, ANDA076309_003, ANDA076309_004, ANDA076309_005
9ANDA076409NEFAZODONE HYDROCHLORIDESUN PHARMACEUTICAL INDUSTRIES LTD2003-09-16ANDA076409_001, ANDA076409_002, ANDA076409_003, ANDA076409_004, ANDA076409_005
10NDA020152SERZONETrueBRISTOL MYERS SQUIBB CO PHARMACEUTICAL RESEARCH INSTITUTE1994-12-22NDA020152_001, NDA020152_002, NDA020152_003, NDA020152_004, NDA020152_005, NDA020152_006

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA075763_001discontinuedNEFAZODONE HYDROCHLORIDE (50MG)ORALTABLETFalse2003-09-16NEFAZODONE HYDROCHLORIDE
2ANDA075763_002discontinuedNEFAZODONE HYDROCHLORIDE (100MG)ORALTABLETFalse2003-09-16NEFAZODONE HYDROCHLORIDE
3ANDA075763_003discontinuedNEFAZODONE HYDROCHLORIDE (150MG)ORALTABLETFalse2003-09-16NEFAZODONE HYDROCHLORIDE
4ANDA075763_004discontinuedNEFAZODONE HYDROCHLORIDE (200MG)ORALTABLETFalse2003-09-16NEFAZODONE HYDROCHLORIDE
5ANDA075763_005discontinuedNEFAZODONE HYDROCHLORIDE (250MG)ORALTABLETFalse2003-09-16NEFAZODONE HYDROCHLORIDE
6ANDA076037_001RXNEFAZODONE HYDROCHLORIDE (50MG)ORALTABLETFalseAB2003-09-16NEFAZODONE HYDROCHLORIDE
7ANDA076037_002RXNEFAZODONE HYDROCHLORIDE (100MG)ORALTABLETFalseAB2003-09-16NEFAZODONE HYDROCHLORIDE
8ANDA076037_003RXNEFAZODONE HYDROCHLORIDE (150MG)ORALTABLETFalseAB2003-09-16NEFAZODONE HYDROCHLORIDE
9ANDA076037_004RXNEFAZODONE HYDROCHLORIDE (200MG)ORALTABLETFalseAB2003-09-16NEFAZODONE HYDROCHLORIDE
10ANDA076037_005RXNEFAZODONE HYDROCHLORIDE (250MG)ORALTABLETTrueAB2003-09-16NEFAZODONE HYDROCHLORIDE
11ANDA076072_001discontinuedNEFAZODONE HYDROCHLORIDE (50MG)ORALTABLETFalse2003-09-16NEFAZODONE HYDROCHLORIDE
12ANDA076072_002discontinuedNEFAZODONE HYDROCHLORIDE (100MG)ORALTABLETFalse2003-09-16NEFAZODONE HYDROCHLORIDE
13ANDA076072_003discontinuedNEFAZODONE HYDROCHLORIDE (150MG)ORALTABLETFalse2003-09-16NEFAZODONE HYDROCHLORIDE
14ANDA076072_004discontinuedNEFAZODONE HYDROCHLORIDE (200MG)ORALTABLETFalse2003-09-16NEFAZODONE HYDROCHLORIDE
15ANDA076072_005discontinuedNEFAZODONE HYDROCHLORIDE (250MG)ORALTABLETFalse2003-09-16NEFAZODONE HYDROCHLORIDE
16ANDA076073_002discontinuedNEFAZODONE HYDROCHLORIDE (100MG)ORALTABLETFalse2003-09-16NEFAZODONE HYDROCHLORIDE
17ANDA076073_003discontinuedNEFAZODONE HYDROCHLORIDE (150MG)ORALTABLETFalse2003-09-16NEFAZODONE HYDROCHLORIDE
18ANDA076073_004discontinuedNEFAZODONE HYDROCHLORIDE (200MG)ORALTABLETFalse2003-09-16NEFAZODONE HYDROCHLORIDE
19ANDA076073_005discontinuedNEFAZODONE HYDROCHLORIDE (250MG)ORALTABLETFalse2003-09-16NEFAZODONE HYDROCHLORIDE
20ANDA076129_002discontinuedNEFAZODONE HYDROCHLORIDE (100MG)ORALTABLETFalse2003-09-16NEFAZODONE HYDROCHLORIDE
21ANDA076129_003discontinuedNEFAZODONE HYDROCHLORIDE (150MG)ORALTABLETFalse2003-09-16NEFAZODONE HYDROCHLORIDE
22ANDA076129_004discontinuedNEFAZODONE HYDROCHLORIDE (200MG)ORALTABLETFalse2003-09-16NEFAZODONE HYDROCHLORIDE
23ANDA076129_005discontinuedNEFAZODONE HYDROCHLORIDE (250MG)ORALTABLETFalse2003-09-16NEFAZODONE HYDROCHLORIDE
24ANDA076196_001discontinuedNEFAZODONE HYDROCHLORIDE (50MG)ORALTABLETFalse2003-09-16NEFAZODONE HYDROCHLORIDE
25ANDA076196_002discontinuedNEFAZODONE HYDROCHLORIDE (100MG)ORALTABLETFalse2003-09-16NEFAZODONE HYDROCHLORIDE
26ANDA076196_003discontinuedNEFAZODONE HYDROCHLORIDE (150MG)ORALTABLETFalse2003-09-16NEFAZODONE HYDROCHLORIDE
27ANDA076196_004discontinuedNEFAZODONE HYDROCHLORIDE (200MG)ORALTABLETFalse2003-09-16NEFAZODONE HYDROCHLORIDE
28ANDA076196_005discontinuedNEFAZODONE HYDROCHLORIDE (250MG)ORALTABLETFalse2003-09-16NEFAZODONE HYDROCHLORIDE
29ANDA076302_001discontinuedNEFAZODONE HYDROCHLORIDE (50MG)ORALTABLETFalse2003-09-16NEFAZODONE HYDROCHLORIDE
30ANDA076302_002discontinuedNEFAZODONE HYDROCHLORIDE (100MG)ORALTABLETFalse2003-09-16NEFAZODONE HYDROCHLORIDE
31ANDA076302_003discontinuedNEFAZODONE HYDROCHLORIDE (150MG)ORALTABLETFalse2003-09-16NEFAZODONE HYDROCHLORIDE
32ANDA076302_004discontinuedNEFAZODONE HYDROCHLORIDE (200MG)ORALTABLETFalse2003-09-16NEFAZODONE HYDROCHLORIDE
33ANDA076302_005discontinuedNEFAZODONE HYDROCHLORIDE (250MG)ORALTABLETFalse2003-09-16NEFAZODONE HYDROCHLORIDE
34ANDA076309_001RXNEFAZODONE HYDROCHLORIDE (50MG)ORALTABLETFalseBX2003-09-16NEFAZODONE HYDROCHLORIDE
35ANDA076309_002RXNEFAZODONE HYDROCHLORIDE (100MG)ORALTABLETFalseBX2003-09-16NEFAZODONE HYDROCHLORIDE
36ANDA076309_003RXNEFAZODONE HYDROCHLORIDE (150MG)ORALTABLETFalseBX2003-09-16NEFAZODONE HYDROCHLORIDE
37ANDA076309_004RXNEFAZODONE HYDROCHLORIDE (200MG)ORALTABLETFalseBX2003-09-16NEFAZODONE HYDROCHLORIDE
38ANDA076309_005RXNEFAZODONE HYDROCHLORIDE (250MG)ORALTABLETFalseBX2003-09-16NEFAZODONE HYDROCHLORIDE
39ANDA076409_001RXNEFAZODONE HYDROCHLORIDE (50MG)ORALTABLETFalseAB2003-09-16NEFAZODONE HYDROCHLORIDE
40ANDA076409_002RXNEFAZODONE HYDROCHLORIDE (100MG)ORALTABLETFalseAB2003-09-16NEFAZODONE HYDROCHLORIDE
41ANDA076409_003RXNEFAZODONE HYDROCHLORIDE (150MG)ORALTABLETFalseAB2003-09-16NEFAZODONE HYDROCHLORIDE
42ANDA076409_004RXNEFAZODONE HYDROCHLORIDE (200MG)ORALTABLETFalseAB2003-09-16NEFAZODONE HYDROCHLORIDE
43ANDA076409_005RXNEFAZODONE HYDROCHLORIDE (250MG)ORALTABLETFalseAB2003-09-16NEFAZODONE HYDROCHLORIDE
44NDA020152_001discontinuedNEFAZODONE HYDROCHLORIDE (50MG)ORALTABLETFalse1994-12-22SERZONE
45NDA020152_002discontinuedNEFAZODONE HYDROCHLORIDE (100MG)ORALTABLETFalse1994-12-22SERZONE
46NDA020152_003discontinuedNEFAZODONE HYDROCHLORIDE (150MG)ORALTABLETFalse1994-12-22SERZONE
47NDA020152_004discontinuedNEFAZODONE HYDROCHLORIDE (200MG)ORALTABLETFalse1994-12-22SERZONE
48NDA020152_005discontinuedNEFAZODONE HYDROCHLORIDE (250MG)ORALTABLETFalse1994-12-22SERZONE
49NDA020152_006discontinuedNEFAZODONE HYDROCHLORIDE (300MG)ORALTABLETFalse1994-12-22SERZONE

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
11109ac28-47eb-4dc7-8abc-8bc1f19b25eb (view SPL)prescriptionHuman PrescriptionRemedyrepack Inc.2011-06-081493490292
230f2dc3f-a5da-40da-9314-12935cbdac7d (view SPL)prescriptionHuman PrescriptionStat Rx Usa Llcrelabel, repack2011-04-071165900166
34afee435-ae60-4260-a1df-e52abf7a043d (view SPL)NEFAZODONE HYDROCHLORIDE TABLETS71781024711310251026(Patient Information Included)prescriptionHuman PrescriptionRebel Distributors CorpRELABEL, REPACK2010-12-291216950174, 216950175, 216950176, 216950177
451ff7db5-aaf9-4c3c-86e6-958ebf16b60f (view SPL)NEFAZODONE HYDROCHLORIDE TABLETS USP 7178 1024 7113 1025 1026 Rx only (Patient Information Included)prescriptionHuman PrescriptionTeva Pharmaceuticals Usa Inc2014-06-024000931024, 000931025, 000931026, 000937113, 000937178
5916f119c-836f-dbec-45e0-047c0f527925 (view SPL)NEFAZODONE HYDROCHLORIDE TABLETSprescriptionHuman PrescriptionAvkare, Inc.2013-12-163422910627, 422910631

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