Application 204172

Type
ANDA
Sponsor
LUPIN LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DESVENLAFAXINE SUCCINATEDESVENLAFAXINE SUCCINATETABLET, EXTENDED RELEASE;ORALEQ 50MG BASENoNo
002DESVENLAFAXINE SUCCINATEDESVENLAFAXINE SUCCINATETABLET, EXTENDED RELEASE;ORALEQ 100MG BASENoNo
003DESVENLAFAXINE SUCCINATEDESVENLAFAXINE SUCCINATETABLET, EXTENDED RELEASE;ORALEQ 25MG BASENoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A204172-001DESVENLAFAXINE SUCCINATEDESVENLAFAXINE SUCCINATEEQ 50MG BASETABLET, EXTENDED RELEASE / ORALAB2015-06-29
A204172-002DESVENLAFAXINE SUCCINATEDESVENLAFAXINE SUCCINATEEQ 100MG BASETABLET, EXTENDED RELEASE / ORALAB2015-06-29
A204172-003DESVENLAFAXINE SUCCINATEDESVENLAFAXINE SUCCINATEEQ 25MG BASETABLET, EXTENDED RELEASE / ORALAB2022-04-13

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A204172-001AB
A204172-002AB
A204172-003AB

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 3 · 114 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A204172-001DESVENLAFAXINE SUCCINATEEQ 50MG BASETABLET, EXTENDED RELEASE / ORALAB2015-06-29caaa826d4ba7…
2026-08-18 06:07:402026-07A204172-002DESVENLAFAXINE SUCCINATEEQ 100MG BASETABLET, EXTENDED RELEASE / ORALAB2015-06-29caaa826d4ba7…
2026-08-18 06:07:402026-07A204172-003DESVENLAFAXINE SUCCINATEEQ 25MG BASETABLET, EXTENDED RELEASE / ORALAB2022-04-13caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A204172-001DESVENLAFAXINE SUCCINATEEQ 50MG BASETABLET, EXTENDED RELEASE / ORALAB2015-06-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204172-002DESVENLAFAXINE SUCCINATEEQ 100MG BASETABLET, EXTENDED RELEASE / ORALAB2015-06-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204172-003DESVENLAFAXINE SUCCINATEEQ 25MG BASETABLET, EXTENDED RELEASE / ORALAB2022-04-13011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204172-001DESVENLAFAXINE SUCCINATEEQ 50MG BASETABLET, EXTENDED RELEASE / ORALAB2015-06-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204172-002DESVENLAFAXINE SUCCINATEEQ 100MG BASETABLET, EXTENDED RELEASE / ORALAB2015-06-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204172-003DESVENLAFAXINE SUCCINATEEQ 25MG BASETABLET, EXTENDED RELEASE / ORALAB2022-04-1331067a03dcf5…
2025-08-23 18:47 UTC2025-08A204172-001DESVENLAFAXINE SUCCINATEEQ 50MG BASETABLET, EXTENDED RELEASE / ORALAB2015-06-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204172-002DESVENLAFAXINE SUCCINATEEQ 100MG BASETABLET, EXTENDED RELEASE / ORALAB2015-06-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204172-003DESVENLAFAXINE SUCCINATEEQ 25MG BASETABLET, EXTENDED RELEASE / ORALAB2022-04-136a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204172-001DESVENLAFAXINE SUCCINATEEQ 50MG BASETABLET, EXTENDED RELEASE / ORALAB2015-06-29fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204172-002DESVENLAFAXINE SUCCINATEEQ 100MG BASETABLET, EXTENDED RELEASE / ORALAB2015-06-29fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204172-003DESVENLAFAXINE SUCCINATEEQ 25MG BASETABLET, EXTENDED RELEASE / ORALAB2022-04-13fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204172-001DESVENLAFAXINE SUCCINATEEQ 50MG BASETABLET, EXTENDED RELEASE / ORALAB2015-06-29b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204172-002DESVENLAFAXINE SUCCINATEEQ 100MG BASETABLET, EXTENDED RELEASE / ORALAB2015-06-29b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204172-003DESVENLAFAXINE SUCCINATEEQ 25MG BASETABLET, EXTENDED RELEASE / ORALAB2022-04-13b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204172-001DESVENLAFAXINE SUCCINATEEQ 50MG BASETABLET, EXTENDED RELEASE / ORALAB2015-06-2903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204172-002DESVENLAFAXINE SUCCINATEEQ 100MG BASETABLET, EXTENDED RELEASE / ORALAB2015-06-2903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204172-003DESVENLAFAXINE SUCCINATEEQ 25MG BASETABLET, EXTENDED RELEASE / ORALAB2022-04-1303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204172-001DESVENLAFAXINE SUCCINATEEQ 50MG BASETABLET, EXTENDED RELEASE / ORALAB2015-06-292680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204172-002DESVENLAFAXINE SUCCINATEEQ 100MG BASETABLET, EXTENDED RELEASE / ORALAB2015-06-292680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204172-003DESVENLAFAXINE SUCCINATEEQ 25MG BASETABLET, EXTENDED RELEASE / ORALAB2022-04-132680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204172-001DESVENLAFAXINE SUCCINATEEQ 50MG BASETABLET, EXTENDED RELEASE / ORALAB2015-06-295bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204172-002DESVENLAFAXINE SUCCINATEEQ 100MG BASETABLET, EXTENDED RELEASE / ORALAB2015-06-295bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204172-003DESVENLAFAXINE SUCCINATEEQ 25MG BASETABLET, EXTENDED RELEASE / ORALAB2022-04-135bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204172-001DESVENLAFAXINE SUCCINATEEQ 50MG BASETABLET, EXTENDED RELEASE / ORALAB2015-06-29d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204172-002DESVENLAFAXINE SUCCINATEEQ 100MG BASETABLET, EXTENDED RELEASE / ORALAB2015-06-29d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204172-003DESVENLAFAXINE SUCCINATEEQ 25MG BASETABLET, EXTENDED RELEASE / ORALAB2022-04-13d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A204172-001DESVENLAFAXINE SUCCINATEEQ 50MG BASETABLET, EXTENDED RELEASE / ORALAB2015-06-29d06236e962d9…
2024-10-29 15:01 UTC2024-10A204172-002DESVENLAFAXINE SUCCINATEEQ 100MG BASETABLET, EXTENDED RELEASE / ORALAB2015-06-29d06236e962d9…
2024-10-29 15:01 UTC2024-10A204172-003DESVENLAFAXINE SUCCINATEEQ 25MG BASETABLET, EXTENDED RELEASE / ORALAB2022-04-13d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A204172-001DESVENLAFAXINE SUCCINATEEQ 50MG BASETABLET, EXTENDED RELEASE / ORALAB2015-06-2979d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A204172-002DESVENLAFAXINE SUCCINATEEQ 100MG BASETABLET, EXTENDED RELEASE / ORALAB2015-06-2979d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A204172-003DESVENLAFAXINE SUCCINATEEQ 25MG BASETABLET, EXTENDED RELEASE / ORALAB2022-04-1379d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A204172-001DESVENLAFAXINE SUCCINATEEQ 50MG BASETABLET, EXTENDED RELEASE / ORALAB2015-06-29301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A204172-002DESVENLAFAXINE SUCCINATEEQ 100MG BASETABLET, EXTENDED RELEASE / ORALAB2015-06-29301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A204172-003DESVENLAFAXINE SUCCINATEEQ 25MG BASETABLET, EXTENDED RELEASE / ORALAB2022-04-13301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A204172-001DESVENLAFAXINE SUCCINATEEQ 50MG BASETABLET, EXTENDED RELEASE / ORALAB2015-06-291e350fbaab3a…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 114 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A204172-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A204172-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A204172-003AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A204172-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204172-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204172-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204172-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204172-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204172-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A204172-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204172-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204172-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204172-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204172-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204172-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204172-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204172-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204172-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204172-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204172-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204172-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204172-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204172-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204172-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204172-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204172-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204172-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204172-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204172-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204172-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A204172-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A204172-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A204172-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A204172-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A204172-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A204172-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A204172-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A204172-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A204172-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A204172-001AB11e350fbaab3a…

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 · 8 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Desvenlafaxine SuccinateDESVENLAFAXINE SUCCINATEBryant Ranch Prepack56c9e8ee-1460-4a4c-8033-65d9afb358c82026-06-12Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204172
application number: ANDA204172
ndc (product): 71335-1331
Desvenlafaxine SuccinateDESVENLAFAXINE SUCCINATEBryant Ranch Prepack593d340b-f49a-455b-aeb2-5a1eaf7b6cbe2026-06-05Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204172
application number: ANDA204172
ndc (product): 71335-1150
Desvenlafaxine SuccinateDESVENLAFAXINE SUCCINATEA-S Medication Solutions5755f1b2-c10b-47f6-a08d-38d1c05bd3532026-05-08Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204172
application number: ANDA204172
Desvenlafaxine SuccinateDESVENLAFAXINE SUCCINATEBryant Ranch Prepack5f349cc5-b803-462d-b323-d681bd1a02f02026-05-08Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204172
application number: ANDA204172
Desvenlafaxine SuccinateDESVENLAFAXINE SUCCINATEPreferred Pharmaceuticals Inc.453a5759-2f0d-421d-be78-81ab97c8ce772026-04-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204172
application number: ANDA204172
DESVENLAFAXINE ERDESVENLAFAXINE ERDirect_Rx8a834c66-846e-38a8-e053-2a95a90a40352026-03-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204172
application number: ANDA204172
ndc (product): 61919-882
Desvenlafaxine SuccinateDESVENLAFAXINE SUCCINATELupin Pharmaceuticals, Inc.e96272a2-8f73-4fbe-a8d4-a78d4ad688312025-12-29Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204172
application number: ANDA204172
ndc (product): 68180-604
ndc (product): 68180-592
ndc (product): 68180-593
Desvenlafaxine SuccinateDESVENLAFAXINE SUCCINATEA-S Medication Solutions7ee04e8c-ce6c-450d-9122-2bffd170bfd72024-12-05Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204172
application number: ANDA204172

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 26 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
61919-882DESVENLAFAXINE ERDESVENLAFAXINE ERDirect_RxANDACurrent
68180-592Desvenlafaxine SuccinateDesvenlafaxine SuccinateLupin Pharmaceuticals, Inc.ANDACurrent
68180-592Desvenlafaxine SuccinateDesvenlafaxine SuccinateLupin Pharmaceuticals, Inc.ANDACurrent
68180-592Desvenlafaxine SuccinateDesvenlafaxine SuccinateLupin Pharmaceuticals, Inc.ANDACurrent
68180-592Desvenlafaxine SuccinateDesvenlafaxine SuccinateLupin Pharmaceuticals, Inc.ANDACurrent
68180-592Desvenlafaxine SuccinateDesvenlafaxine SuccinateLupin Pharmaceuticals, Inc.ANDACurrent
68180-593Desvenlafaxine SuccinateDesvenlafaxine SuccinateLupin Pharmaceuticals, Inc.ANDACurrent
68180-593Desvenlafaxine SuccinateDesvenlafaxine SuccinateLupin Pharmaceuticals, Inc.ANDACurrent
68180-593Desvenlafaxine SuccinateDesvenlafaxine SuccinateLupin Pharmaceuticals, Inc.ANDACurrent
68180-593Desvenlafaxine SuccinateDesvenlafaxine SuccinateLupin Pharmaceuticals, Inc.ANDACurrent
68180-593Desvenlafaxine SuccinateDesvenlafaxine SuccinateLupin Pharmaceuticals, Inc.ANDACurrent
68180-604Desvenlafaxine SuccinateDesvenlafaxine SuccinateLupin Pharmaceuticals, Inc.ANDACurrent
68180-604Desvenlafaxine SuccinateDesvenlafaxine SuccinateLupin Pharmaceuticals, Inc.ANDACurrent
68788-7448Desvenlafaxine SuccinateDesvenlafaxine SuccinatePreferred Pharmaceuticals Inc.ANDACurrent
68788-7448Desvenlafaxine SuccinateDesvenlafaxine SuccinatePreferred Pharmaceuticals Inc.ANDACurrent
68788-7448Desvenlafaxine SuccinateDesvenlafaxine SuccinatePreferred Pharmaceuticals Inc.ANDACurrent
68788-7488Desvenlafaxine SuccinateDesvenlafaxine SuccinatePreferred Pharmaceuticals Inc.ANDACurrent
68788-7488Desvenlafaxine SuccinateDesvenlafaxine SuccinatePreferred Pharmaceuticals Inc.ANDACurrent
71335-1150Desvenlafaxine SuccinateDesvenlafaxine SuccinateBryant Ranch PrepackANDACurrent
71335-1150Desvenlafaxine SuccinateDesvenlafaxine SuccinateBryant Ranch PrepackANDACurrent
71335-1150Desvenlafaxine SuccinateDesvenlafaxine SuccinateBryant Ranch PrepackANDACurrent
71335-1150Desvenlafaxine SuccinateDesvenlafaxine SuccinateBryant Ranch PrepackANDACurrent
71335-1150Desvenlafaxine SuccinateDesvenlafaxine SuccinateBryant Ranch PrepackANDACurrent
71335-1331Desvenlafaxine SuccinateDesvenlafaxine SuccinateBryant Ranch PrepackANDACurrent
71335-1331Desvenlafaxine SuccinateDesvenlafaxine SuccinateBryant Ranch PrepackANDACurrent
71335-1331Desvenlafaxine SuccinateDesvenlafaxine SuccinateBryant Ranch PrepackANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
10305ORIG2015-07-08