Application 076565

Type
ANDA
Sponsor
TEVA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001VENLAFAXINE HYDROCHLORIDEVENLAFAXINE HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORALEQ 37.5MG BASENoNo
002VENLAFAXINE HYDROCHLORIDEVENLAFAXINE HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORALEQ 75MG BASENoNo
003VENLAFAXINE HYDROCHLORIDEVENLAFAXINE HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORALEQ 150MG BASENoNo

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

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A076565-001VENLAFAXINE HYDROCHLORIDEVENLAFAXINE HYDROCHLORIDEEQ 37.5MG BASECAPSULE, EXTENDED RELEASE / ORALAB2010-06-28
A076565-002VENLAFAXINE HYDROCHLORIDEVENLAFAXINE HYDROCHLORIDEEQ 75MG BASECAPSULE, EXTENDED RELEASE / ORALAB2010-06-28
A076565-003VENLAFAXINE HYDROCHLORIDEVENLAFAXINE HYDROCHLORIDEEQ 150MG BASECAPSULE, EXTENDED RELEASE / ORALAB2010-06-28

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
A076565-001AB
A076565-002AB
A076565-003AB

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 4 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A076565-001VENLAFAXINE HYDROCHLORIDEEQ 37.5MG BASECAPSULE, EXTENDED RELEASE / ORALAB2010-06-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076565-002VENLAFAXINE HYDROCHLORIDEEQ 75MG BASECAPSULE, EXTENDED RELEASE / ORALAB2010-06-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076565-003VENLAFAXINE HYDROCHLORIDEEQ 150MG BASECAPSULE, EXTENDED RELEASE / ORALAB2010-06-28011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076565-001VENLAFAXINE HYDROCHLORIDEEQ 37.5MG BASECAPSULE, EXTENDED RELEASE / ORALAB2010-06-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076565-002VENLAFAXINE HYDROCHLORIDEEQ 75MG BASECAPSULE, EXTENDED RELEASE / ORALAB2010-06-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076565-003VENLAFAXINE HYDROCHLORIDEEQ 150MG BASECAPSULE, EXTENDED RELEASE / ORALAB2010-06-2831067a03dcf5…
2025-08-23 18:47 UTC2025-08A076565-001VENLAFAXINE HYDROCHLORIDEEQ 37.5MG BASECAPSULE, EXTENDED RELEASE / ORALAB2010-06-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076565-002VENLAFAXINE HYDROCHLORIDEEQ 75MG BASECAPSULE, EXTENDED RELEASE / ORALAB2010-06-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076565-003VENLAFAXINE HYDROCHLORIDEEQ 150MG BASECAPSULE, EXTENDED RELEASE / ORALAB2010-06-286a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076565-001VENLAFAXINE HYDROCHLORIDEEQ 37.5MG BASECAPSULE, EXTENDED RELEASE / ORALAB2010-06-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076565-002VENLAFAXINE HYDROCHLORIDEEQ 75MG BASECAPSULE, EXTENDED RELEASE / ORALAB2010-06-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076565-003VENLAFAXINE HYDROCHLORIDEEQ 150MG BASECAPSULE, EXTENDED RELEASE / ORALAB2010-06-28fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076565-001VENLAFAXINE HYDROCHLORIDEEQ 37.5MG BASECAPSULE, EXTENDED RELEASE / ORALAB2010-06-28b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076565-002VENLAFAXINE HYDROCHLORIDEEQ 75MG BASECAPSULE, EXTENDED RELEASE / ORALAB2010-06-28b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076565-003VENLAFAXINE HYDROCHLORIDEEQ 150MG BASECAPSULE, EXTENDED RELEASE / ORALAB2010-06-28b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076565-001VENLAFAXINE HYDROCHLORIDEEQ 37.5MG BASECAPSULE, EXTENDED RELEASE / ORALAB2010-06-2803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076565-002VENLAFAXINE HYDROCHLORIDEEQ 75MG BASECAPSULE, EXTENDED RELEASE / ORALAB2010-06-2803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076565-003VENLAFAXINE HYDROCHLORIDEEQ 150MG BASECAPSULE, EXTENDED RELEASE / ORALAB2010-06-2803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076565-001VENLAFAXINE HYDROCHLORIDEEQ 37.5MG BASECAPSULE, EXTENDED RELEASE / ORALAB2010-06-282680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076565-002VENLAFAXINE HYDROCHLORIDEEQ 75MG BASECAPSULE, EXTENDED RELEASE / ORALAB2010-06-282680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076565-003VENLAFAXINE HYDROCHLORIDEEQ 150MG BASECAPSULE, EXTENDED RELEASE / ORALAB2010-06-282680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076565-001VENLAFAXINE HYDROCHLORIDEEQ 37.5MG BASECAPSULE, EXTENDED RELEASE / ORALAB2010-06-285bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076565-002VENLAFAXINE HYDROCHLORIDEEQ 75MG BASECAPSULE, EXTENDED RELEASE / ORALAB2010-06-285bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076565-003VENLAFAXINE HYDROCHLORIDEEQ 150MG BASECAPSULE, EXTENDED RELEASE / ORALAB2010-06-285bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076565-001VENLAFAXINE HYDROCHLORIDEEQ 37.5MG BASECAPSULE, EXTENDED RELEASE / ORALAB2010-06-28d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076565-002VENLAFAXINE HYDROCHLORIDEEQ 75MG BASECAPSULE, EXTENDED RELEASE / ORALAB2010-06-28d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076565-003VENLAFAXINE HYDROCHLORIDEEQ 150MG BASECAPSULE, EXTENDED RELEASE / ORALAB2010-06-28d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A076565-001VENLAFAXINE HYDROCHLORIDEEQ 37.5MG BASECAPSULE, EXTENDED RELEASE / ORALAB2010-06-28d06236e962d9…
2024-10-29 15:01 UTC2024-10A076565-002VENLAFAXINE HYDROCHLORIDEEQ 75MG BASECAPSULE, EXTENDED RELEASE / ORALAB2010-06-28d06236e962d9…
2024-10-29 15:01 UTC2024-10A076565-003VENLAFAXINE HYDROCHLORIDEEQ 150MG BASECAPSULE, EXTENDED RELEASE / ORALAB2010-06-28d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076565-001VENLAFAXINE HYDROCHLORIDEEQ 37.5MG BASECAPSULE, EXTENDED RELEASE / ORALAB2010-06-2879d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076565-002VENLAFAXINE HYDROCHLORIDEEQ 75MG BASECAPSULE, EXTENDED RELEASE / ORALAB2010-06-2879d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076565-003VENLAFAXINE HYDROCHLORIDEEQ 150MG BASECAPSULE, EXTENDED RELEASE / ORALAB2010-06-2879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076565-001VENLAFAXINE HYDROCHLORIDEEQ 37.5MG BASECAPSULE, EXTENDED RELEASE / ORALAB2010-06-28301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076565-002VENLAFAXINE HYDROCHLORIDEEQ 75MG BASECAPSULE, EXTENDED RELEASE / ORALAB2010-06-28301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076565-003VENLAFAXINE HYDROCHLORIDEEQ 150MG BASECAPSULE, EXTENDED RELEASE / ORALAB2010-06-28301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076565-001VENLAFAXINE HYDROCHLORIDEEQ 37.5MG BASECAPSULE, EXTENDED RELEASE / ORALAB2010-06-281e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076565-002VENLAFAXINE HYDROCHLORIDEEQ 75MG BASECAPSULE, EXTENDED RELEASE / ORALAB2010-06-281e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076565-003VENLAFAXINE HYDROCHLORIDEEQ 150MG BASECAPSULE, EXTENDED RELEASE / ORALAB2010-06-281e350fbaab3a…
2024-05-31 18:47 UTC2024-05A076565-001VENLAFAXINE HYDROCHLORIDEEQ 37.5MG BASECAPSULE, EXTENDED RELEASE / ORALAB2010-06-288072bd15b7f6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A076565-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076565-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076565-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076565-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076565-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076565-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A076565-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076565-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076565-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076565-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076565-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076565-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076565-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076565-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076565-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076565-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076565-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076565-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076565-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076565-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076565-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076565-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076565-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076565-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076565-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076565-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076565-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A076565-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A076565-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A076565-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076565-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076565-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076565-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076565-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076565-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076565-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076565-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076565-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076565-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A076565-001AB18072bd15b7f6…

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 · 7 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Venlafaxine HydrochlorideVENLAFAXINE HYDROCHLORIDEAvKARE7f224c88-9425-9ef0-01bc-dcf3bdafbd892026-01-16Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076565
application number: ANDA076565
Venlafaxine HydrochlorideVENLAFAXINE HYDROCHLORIDEQPharma, Inc.9e745ad7-be4f-4369-be23-587e1154e4ab2025-12-05Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076565
application number: ANDA076565
Venlafaxine HydrochlorideVENLAFAXINE HYDROCHLORIDEProficient Rx LP9f697c00-f5ec-454a-a66c-503aef5fc6092024-10-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076565
application number: ANDA076565
Venlafaxine HydrochlorideVENLAFAXINE HYDROCHLORIDEProficient Rx LP613658d3-7eb5-4822-961f-f4c6f6b2a2c12024-10-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076565
application number: ANDA076565
Venlafaxine HydrochlorideVENLAFAXINE HYDROCHLORIDEProficient Rx LPadeba7dd-bd15-4d8f-b703-24c3a208e7402024-10-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076565
application number: ANDA076565
Venlafaxine HydrochlorideVENLAFAXINE HYDROCHLORIDETeva Pharmaceuticals USA, Inc.9a30e1b5-272b-4109-ad6c-a3c9a895822f2024-03-09Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076565
application number: ANDA076565
Venlafaxine HydrochlorideVENLAFAXINE HYDROCHLORIDEA-S Medication Solutions0aedeaf8-9b6c-4a44-a5fe-9d74516f542d2023-04-04Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076565
application number: ANDA076565

NDC Listings For This Application#

NDC listings for this application page 2 of 2 · 115 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
63629-3325Venlafaxine HydrochlorideVenlafaxine HydrochlorideBryant Ranch PrepackANDACurrent
63629-3325Venlafaxine HydrochlorideVenlafaxine HydrochlorideBryant Ranch PrepackANDACurrent
63629-3325Venlafaxine HydrochlorideVenlafaxine HydrochlorideBryant Ranch PrepackANDACurrent
63629-3325Venlafaxine HydrochlorideVenlafaxine HydrochlorideBryant Ranch PrepackANDACurrent
63629-3325Venlafaxine HydrochlorideVenlafaxine HydrochlorideBryant Ranch PrepackANDACurrent
63629-4534Venlafaxine HydrochlorideVenlafaxine HydrochlorideBryant Ranch PrepackANDACurrent
63629-4534Venlafaxine HydrochlorideVenlafaxine HydrochlorideBryant Ranch PrepackANDACurrent
63629-4534Venlafaxine HydrochlorideVenlafaxine HydrochlorideBryant Ranch PrepackANDACurrent
63629-4725Venlafaxine HydrochlorideVenlafaxine HydrochlorideBryant Ranch PrepackANDACurrent
63629-6884Venlafaxine HydrochlorideVenlafaxine HydrochlorideBryant Ranch PrepackANDACurrent
63629-6884Venlafaxine HydrochlorideVenlafaxine HydrochlorideBryant Ranch PrepackANDACurrent
63629-6884Venlafaxine HydrochlorideVenlafaxine HydrochlorideBryant Ranch PrepackANDACurrent
63629-6884Venlafaxine HydrochlorideVenlafaxine HydrochlorideBryant Ranch PrepackANDACurrent
63629-6885Venlafaxine HydrochlorideVenlafaxine HydrochlorideBryant Ranch PrepackANDACurrent
63629-6885Venlafaxine HydrochlorideVenlafaxine HydrochlorideBryant Ranch PrepackANDACurrent
63629-6885Venlafaxine HydrochlorideVenlafaxine HydrochlorideBryant Ranch PrepackANDACurrent
63629-6885Venlafaxine HydrochlorideVenlafaxine HydrochlorideBryant Ranch PrepackANDACurrent
63629-6932Venlafaxine HydrochlorideVenlafaxine HydrochlorideBryant Ranch PrepackANDACurrent
63629-6932Venlafaxine HydrochlorideVenlafaxine HydrochlorideBryant Ranch PrepackANDACurrent
63629-6932Venlafaxine HydrochlorideVenlafaxine HydrochlorideBryant Ranch PrepackANDACurrent
63629-6932Venlafaxine HydrochlorideVenlafaxine HydrochlorideBryant Ranch PrepackANDACurrent
63739-512Venlafaxine HydrochlorideVenlafaxine HydrochlorideMcKesson CorporationANDACurrent
63739-512Venlafaxine HydrochlorideVenlafaxine HydrochlorideMcKesson Corporation dba SKY PackagingANDACurrent
66116-447Venlafaxine HydrochlorideVenlafaxine HydrochlorideMedVantx, Inc.ANDACurrent
68071-1673Venlafaxine HydrochlorideVenlafaxine Hydrochloride E-RNuCare Pharmaceuticals,Inc.ANDACurrent
68071-1673Venlafaxine HydrochlorideVenlafaxine Hydrochloride E-RNuCare Pharmaceuticals,Inc.ANDACurrent
68071-1673Venlafaxine HydrochlorideVenlafaxine Hydrochloride E-RNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4250Venlafaxine HydrochlorideVenlafaxine HydrochlorideNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4250Venlafaxine HydrochlorideVenlafaxine HydrochlorideNuCare Pharmaceuticals,Inc.ANDACurrent
70518-3427Venlafaxine HydrochlorideVenlafaxine HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-3563Venlafaxine HydrochlorideVenlafaxine HydrochlorideREMEDYREPACK INC.ANDACurrent
70934-735Venlafaxine HydrochlorideVenlafaxine HydrochlorideDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
71335-0563Venlafaxine HydrochlorideVenlafaxine HydrochlorideBryant Ranch PrepackANDACurrent
71335-0563Venlafaxine HydrochlorideVenlafaxine HydrochlorideBryant Ranch PrepackANDACurrent
71335-0563Venlafaxine HydrochlorideVenlafaxine HydrochlorideBryant Ranch PrepackANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
22571ORIG2015-03-09
31139ORIG2010-07-02