FDA.reportPublic FDA data

Application 076037

Type
ANDA
Sponsor
TEVA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001NEFAZODONE HYDROCHLORIDENEFAZODONE HYDROCHLORIDETABLET;ORAL50MGNoNo
002NEFAZODONE HYDROCHLORIDENEFAZODONE HYDROCHLORIDETABLET;ORAL100MGNoNo
003NEFAZODONE HYDROCHLORIDENEFAZODONE HYDROCHLORIDETABLET;ORAL150MGNoNo
004NEFAZODONE HYDROCHLORIDENEFAZODONE HYDROCHLORIDETABLET;ORAL200MGNoNo
005NEFAZODONE HYDROCHLORIDENEFAZODONE HYDROCHLORIDETABLET;ORAL250MGNoYes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 5 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A076037-001NEFAZODONE HYDROCHLORIDENEFAZODONE HYDROCHLORIDE50MGTABLET / ORAL2003-09-16
A076037-002NEFAZODONE HYDROCHLORIDENEFAZODONE HYDROCHLORIDE100MGTABLET / ORAL2003-09-16
A076037-003NEFAZODONE HYDROCHLORIDENEFAZODONE HYDROCHLORIDE150MGTABLET / ORAL2003-09-16
A076037-004NEFAZODONE HYDROCHLORIDENEFAZODONE HYDROCHLORIDE200MGTABLET / ORAL2003-09-16
A076037-005NEFAZODONE HYDROCHLORIDENEFAZODONE HYDROCHLORIDE250MGTABLET / ORALRS2003-09-16

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A076037-001NEFAZODONE HYDROCHLORIDE50MGTABLET / ORAL2003-09-16a50c72e98297…
2026-08-01 22:54:322026-06A076037-002NEFAZODONE HYDROCHLORIDE100MGTABLET / ORAL2003-09-16a50c72e98297…
2026-08-01 22:54:322026-06A076037-003NEFAZODONE HYDROCHLORIDE150MGTABLET / ORAL2003-09-16a50c72e98297…
2026-08-01 22:54:322026-06A076037-004NEFAZODONE HYDROCHLORIDE200MGTABLET / ORAL2003-09-16a50c72e98297…
2026-08-01 22:54:322026-06A076037-005NEFAZODONE HYDROCHLORIDE250MGTABLET / ORALRS2003-09-16a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Nefazodone HydrochlorideNEFAZODONE HYDROCHLORIDEBryant Ranch Prepack0bd4c34a-4f43-4c84-8b98-1d074cba97d52025-09-04Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076037
application number: ANDA076037
ndc (product): 63629-7046
Nefazodone HydrochlorideNEFAZODONE HYDROCHLORIDETeva Pharmaceuticals USA, Inc.51ff7db5-aaf9-4c3c-86e6-958ebf16b60f2025-07-31Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076037
application number: ANDA076037
ndc (product): 0093-7178
ndc (product): 0093-1024
ndc (product): 0093-1026
ndc (product): 0093-1025
ndc (product): 0093-7113

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 45 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0093-1024Nefazodone HydrochlorideNefazodone HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-1024Nefazodone HydrochlorideNefazodone HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-1024Nefazodone HydrochlorideNefazodone HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-1024Nefazodone HydrochlorideNefazodone HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-1024Nefazodone HydrochlorideNefazodone HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-1025Nefazodone HydrochlorideNefazodone HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-1025Nefazodone HydrochlorideNefazodone HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-1025Nefazodone HydrochlorideNefazodone HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-1025Nefazodone HydrochlorideNefazodone HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-1025Nefazodone HydrochlorideNefazodone HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-1026Nefazodone HydrochlorideNefazodone HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-1026Nefazodone HydrochlorideNefazodone HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-1026Nefazodone HydrochlorideNefazodone HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-1026Nefazodone HydrochlorideNefazodone HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-1026Nefazodone HydrochlorideNefazodone HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-7113Nefazodone HydrochlorideNefazodone HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-7113Nefazodone HydrochlorideNefazodone HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-7113Nefazodone HydrochlorideNefazodone HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-7113Nefazodone HydrochlorideNefazodone HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-7113Nefazodone HydrochlorideNefazodone HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-7178Nefazodone HydrochlorideNefazodone HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-7178Nefazodone HydrochlorideNefazodone HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-7178Nefazodone HydrochlorideNefazodone HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-7178Nefazodone HydrochlorideNefazodone HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-7178Nefazodone HydrochlorideNefazodone HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent
21695-174Nefazodone HydrochlorideNefazodone HydrochlorideRebel Distributors CorpANDACurrent
21695-175Nefazodone HydrochlorideNefazodone HydrochlorideRebel Distributors CorpANDACurrent
21695-176Nefazodone HydrochlorideNefazodone HydrochlorideRebel Distributors CorpANDACurrent
21695-177Nefazodone HydrochlorideNefazodone HydrochlorideRebel Distributors CorpANDACurrent
63629-7046Nefazodone HydrochlorideNefazodone HydrochlorideBryant Ranch PrepackANDACurrent
63629-7046Nefazodone HydrochlorideNefazodone HydrochlorideBryant Ranch PrepackANDACurrent
63629-7046Nefazodone HydrochlorideNefazodone HydrochlorideBryant Ranch PrepackANDACurrent
63629-7214Nefazodone HydrochlorideNefazodone HydrochlorideBryant Ranch PrepackANDACurrent
63629-7214Nefazodone HydrochlorideNefazodone HydrochlorideBryant Ranch PrepackANDACurrent
63629-7310Nefazodone HydrochlorideNefazodone HydrochlorideBryant Ranch PrepackANDACurrent
63629-7310Nefazodone HydrochlorideNefazodone HydrochlorideBryant Ranch PrepackANDACurrent
68788-7217Nefazodone HydrochlorideNefazodone HydrochloridePreferred Pharmaceuticals Inc.ANDACurrent
68788-7217Nefazodone HydrochlorideNefazodone HydrochloridePreferred Pharmaceuticals Inc.ANDACurrent
68788-7217Nefazodone HydrochlorideNefazodone HydrochloridePreferred Pharmaceuticals Inc.ANDACurrent
68788-7242Nefazodone HydrochlorideNefazodone HydrochloridePreferred Pharmaceuticals Inc.ANDACurrent
68788-7242Nefazodone HydrochlorideNefazodone HydrochloridePreferred Pharmaceuticals Inc.ANDACurrent
68788-7242Nefazodone HydrochlorideNefazodone HydrochloridePreferred Pharmaceuticals Inc.ANDACurrent
68788-7246Nefazodone HydrochlorideNefazodone HydrochloridePreferred Pharmaceuticals Inc.ANDACurrent
68788-7246Nefazodone HydrochlorideNefazodone HydrochloridePreferred Pharmaceuticals Inc.ANDACurrent
68788-7246Nefazodone HydrochlorideNefazodone HydrochloridePreferred Pharmaceuticals Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
39501SUPPL2014-09-05
44283ORIG2007-05-09