Application 077653

Type
ANDA
Sponsor
ZYDUS PHARMS USA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001VENLAFAXINE HYDROCHLORIDEVENLAFAXINE HYDROCHLORIDETABLET;ORALEQ 25MG BASENoNo
002VENLAFAXINE HYDROCHLORIDEVENLAFAXINE HYDROCHLORIDETABLET;ORALEQ 37.5MG BASENoNo
003VENLAFAXINE HYDROCHLORIDEVENLAFAXINE HYDROCHLORIDETABLET;ORALEQ 50MG BASENoNo
004VENLAFAXINE HYDROCHLORIDEVENLAFAXINE HYDROCHLORIDETABLET;ORALEQ 75MG BASENoNo
005VENLAFAXINE HYDROCHLORIDEVENLAFAXINE HYDROCHLORIDETABLET;ORALEQ 100MG BASENoNo

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
A077653-001VENLAFAXINE HYDROCHLORIDEVENLAFAXINE HYDROCHLORIDEEQ 25MG BASETABLET / ORALAB2008-06-13
A077653-002VENLAFAXINE HYDROCHLORIDEVENLAFAXINE HYDROCHLORIDEEQ 37.5MG BASETABLET / ORALAB2008-06-13
A077653-003VENLAFAXINE HYDROCHLORIDEVENLAFAXINE HYDROCHLORIDEEQ 50MG BASETABLET / ORALAB2008-06-13
A077653-004VENLAFAXINE HYDROCHLORIDEVENLAFAXINE HYDROCHLORIDEEQ 75MG BASETABLET / ORALAB2008-06-13
A077653-005VENLAFAXINE HYDROCHLORIDEVENLAFAXINE HYDROCHLORIDEEQ 100MG BASETABLET / ORALAB2008-06-13

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 5 matching rows.

Application-product, TE code table
Application-productTE code
A077653-001AB
A077653-002AB
A077653-003AB
A077653-004AB
A077653-005AB

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.

Product history page 1 of 6 · 205 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A077653-001VENLAFAXINE HYDROCHLORIDEEQ 25MG BASETABLET / ORALAB2008-06-13011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077653-002VENLAFAXINE HYDROCHLORIDEEQ 37.5MG BASETABLET / ORALAB2008-06-13011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077653-003VENLAFAXINE HYDROCHLORIDEEQ 50MG BASETABLET / ORALAB2008-06-13011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077653-004VENLAFAXINE HYDROCHLORIDEEQ 75MG BASETABLET / ORALAB2008-06-13011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077653-005VENLAFAXINE HYDROCHLORIDEEQ 100MG BASETABLET / ORALAB2008-06-13011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077653-001VENLAFAXINE HYDROCHLORIDEEQ 25MG BASETABLET / ORALAB2008-06-1331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077653-002VENLAFAXINE HYDROCHLORIDEEQ 37.5MG BASETABLET / ORALAB2008-06-1331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077653-003VENLAFAXINE HYDROCHLORIDEEQ 50MG BASETABLET / ORALAB2008-06-1331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077653-004VENLAFAXINE HYDROCHLORIDEEQ 75MG BASETABLET / ORALAB2008-06-1331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077653-005VENLAFAXINE HYDROCHLORIDEEQ 100MG BASETABLET / ORALAB2008-06-1331067a03dcf5…
2025-08-23 18:47 UTC2025-08A077653-001VENLAFAXINE HYDROCHLORIDEEQ 25MG BASETABLET / ORALAB2008-06-136a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077653-002VENLAFAXINE HYDROCHLORIDEEQ 37.5MG BASETABLET / ORALAB2008-06-136a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077653-003VENLAFAXINE HYDROCHLORIDEEQ 50MG BASETABLET / ORALAB2008-06-136a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077653-004VENLAFAXINE HYDROCHLORIDEEQ 75MG BASETABLET / ORALAB2008-06-136a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077653-005VENLAFAXINE HYDROCHLORIDEEQ 100MG BASETABLET / ORALAB2008-06-136a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077653-001VENLAFAXINE HYDROCHLORIDEEQ 25MG BASETABLET / ORALAB2008-06-13fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077653-002VENLAFAXINE HYDROCHLORIDEEQ 37.5MG BASETABLET / ORALAB2008-06-13fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077653-003VENLAFAXINE HYDROCHLORIDEEQ 50MG BASETABLET / ORALAB2008-06-13fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077653-004VENLAFAXINE HYDROCHLORIDEEQ 75MG BASETABLET / ORALAB2008-06-13fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077653-005VENLAFAXINE HYDROCHLORIDEEQ 100MG BASETABLET / ORALAB2008-06-13fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077653-001VENLAFAXINE HYDROCHLORIDEEQ 25MG BASETABLET / ORALAB2008-06-13b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077653-002VENLAFAXINE HYDROCHLORIDEEQ 37.5MG BASETABLET / ORALAB2008-06-13b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077653-003VENLAFAXINE HYDROCHLORIDEEQ 50MG BASETABLET / ORALAB2008-06-13b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077653-004VENLAFAXINE HYDROCHLORIDEEQ 75MG BASETABLET / ORALAB2008-06-13b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077653-005VENLAFAXINE HYDROCHLORIDEEQ 100MG BASETABLET / ORALAB2008-06-13b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077653-001VENLAFAXINE HYDROCHLORIDEEQ 25MG BASETABLET / ORALAB2008-06-1303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077653-002VENLAFAXINE HYDROCHLORIDEEQ 37.5MG BASETABLET / ORALAB2008-06-1303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077653-003VENLAFAXINE HYDROCHLORIDEEQ 50MG BASETABLET / ORALAB2008-06-1303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077653-004VENLAFAXINE HYDROCHLORIDEEQ 75MG BASETABLET / ORALAB2008-06-1303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077653-005VENLAFAXINE HYDROCHLORIDEEQ 100MG BASETABLET / ORALAB2008-06-1303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077653-001VENLAFAXINE HYDROCHLORIDEEQ 25MG BASETABLET / ORALAB2008-06-132680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077653-002VENLAFAXINE HYDROCHLORIDEEQ 37.5MG BASETABLET / ORALAB2008-06-132680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077653-003VENLAFAXINE HYDROCHLORIDEEQ 50MG BASETABLET / ORALAB2008-06-132680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077653-004VENLAFAXINE HYDROCHLORIDEEQ 75MG BASETABLET / ORALAB2008-06-132680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077653-005VENLAFAXINE HYDROCHLORIDEEQ 100MG BASETABLET / ORALAB2008-06-132680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077653-001VENLAFAXINE HYDROCHLORIDEEQ 25MG BASETABLET / ORALAB2008-06-135bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077653-002VENLAFAXINE HYDROCHLORIDEEQ 37.5MG BASETABLET / ORALAB2008-06-135bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077653-003VENLAFAXINE HYDROCHLORIDEEQ 50MG BASETABLET / ORALAB2008-06-135bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077653-004VENLAFAXINE HYDROCHLORIDEEQ 75MG BASETABLET / ORALAB2008-06-135bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077653-005VENLAFAXINE HYDROCHLORIDEEQ 100MG BASETABLET / ORALAB2008-06-135bbf6a4d5a75…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 6 · 205 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A077653-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077653-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077653-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077653-004AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077653-005AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077653-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077653-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077653-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077653-004AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077653-005AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A077653-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077653-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077653-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077653-004AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077653-005AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077653-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077653-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077653-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077653-004AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077653-005AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077653-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077653-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077653-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077653-004AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077653-005AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077653-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077653-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077653-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077653-004AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077653-005AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077653-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077653-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077653-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077653-004AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077653-005AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077653-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077653-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077653-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077653-004AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077653-005AB15bbf6a4d5a75…

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 14 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
VenlafaxineVENLAFAXINESt. Mary's Medical Park Pharmacyfab65158-b2f7-1db7-e053-6294a90af2312026-06-22Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077653
application number: ANDA077653
VenlafaxineVENLAFAXINEBryant Ranch Prepackd4638a83-2720-430c-b529-c852aa2f73662025-09-26Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077653
application number: ANDA077653
VenlafaxineVENLAFAXINENuCare Pharmaceuticals,Inc.fa1db21b-98b8-3bde-e053-6394a90aa6382025-06-09Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077653
application number: ANDA077653
VenlafaxineVENLAFAXINEA-S Medication Solutions7bbdc9c5-a4b9-44d4-babc-46bd8c2e084a2025-05-15Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077653
application number: ANDA077653
VenlafaxineVENLAFAXINENuCare Pharmaceuticals,Inc.017a84aa-0e1f-f560-e063-6294a90a90692025-02-04Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077653
application number: ANDA077653
VenlafaxineVENLAFAXINENuCare Pharmaceuticals,Inc.fe7de51e-8a81-fe68-e053-6294a90a73392025-02-04Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077653
application number: ANDA077653
VenlafaxineVENLAFAXINEBryant Ranch Prepack185d90ab-1ba4-dd59-0565-e35f0fd39a2d2024-08-28Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077653
application number: ANDA077653
Venlafaxine HydrochlorideVENLAFAXINE HYDROCHLORIDEZydus Lifesciences Limited51334651-7a7f-4653-bf9d-d5be04fd902d2024-08-14Exact identifier
application applno (ANDA): 077653
application number: ANDA077653
VenlafaxineVENLAFAXINEAmerican Health Packagingd8899628-6e1b-40c6-9bc8-553d91ae2d0c2024-08-09Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077653
application number: ANDA077653
VenlafaxineVENLAFAXINEBryant Ranch Prepack1471508e-7fe4-43db-94ea-b4df1bcbafa92024-04-05Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077653
application number: ANDA077653
VenlafaxineVENLAFAXINEBluePoint Laboratories172b3d3d-bdae-47bf-8fba-edd6da1a86492023-08-31Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077653
application number: ANDA077653
VenlafaxineVENLAFAXINEZydus Pharmaceuticals USA Inc.72efad5f-0909-46a5-aa13-ac24fe015fe62023-08-26Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077653
application number: ANDA077653
ndc (product): 68382-019
ndc (product): 68382-020
ndc (product): 68382-021
ndc (product): 68382-018
ndc (product): 68382-101
VenlafaxineVENLAFAXINEA-S Medication Solutionsd3475ce0-1368-4961-a9b9-44c5c33cdc582023-05-09Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077653
application number: ANDA077653
VenlafaxineVENLAFAXINEProficient Rx LPb5fc0187-590c-4bb9-a910-821eb0dc1fc82021-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077653
application number: ANDA077653

NDC Listings For This Application#

NDC listings for this application page 2 of 2 · 113 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
68382-018VenlafaxineVenlafaxineZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-018VenlafaxineVenlafaxineZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-018VenlafaxineVenlafaxineZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-018VenlafaxineVenlafaxineZydus Pharmaceuticals USA Inc.ANDACurrent
68382-019VenlafaxineVenlafaxineZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-019VenlafaxineVenlafaxineZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-019VenlafaxineVenlafaxineZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-019VenlafaxineVenlafaxineZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-019VenlafaxineVenlafaxineZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-019VenlafaxineVenlafaxineZydus Pharmaceuticals USA Inc.ANDACurrent
68382-020VenlafaxineVenlafaxineZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-020VenlafaxineVenlafaxineZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-020VenlafaxineVenlafaxineZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-020VenlafaxineVenlafaxineZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-020VenlafaxineVenlafaxineZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-020VenlafaxineVenlafaxineZydus Pharmaceuticals USA Inc.ANDACurrent
68382-021VenlafaxineVenlafaxineZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-021VenlafaxineVenlafaxineZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-021VenlafaxineVenlafaxineZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-021VenlafaxineVenlafaxineZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-021VenlafaxineVenlafaxineZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-021VenlafaxineVenlafaxineZydus Pharmaceuticals USA Inc.ANDACurrent
68382-101VenlafaxineVenlafaxineZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-101VenlafaxineVenlafaxineZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-101VenlafaxineVenlafaxineZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-101VenlafaxineVenlafaxineZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-101VenlafaxineVenlafaxineZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-101VenlafaxineVenlafaxineZydus Pharmaceuticals USA Inc.ANDACurrent
70518-2457VenlafaxineVenlafaxineREMEDYREPACK INC.ANDACurrent
70518-2457VenlafaxineVenlafaxineREMEDYREPACK INC.ANDACurrent
70518-2751VenlafaxineVenlafaxineREMEDYREPACK INC.ANDACurrent
70518-2751VenlafaxineVenlafaxineREMEDYREPACK INC.ANDACurrent
70518-2751VenlafaxineVenlafaxineREMEDYREPACK INC.ANDACurrent