Application 204161

Type
ANDA
Sponsor
ACTAVIS ELIZABETH

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001METOPROLOL SUCCINATEMETOPROLOL SUCCINATETABLET, EXTENDED RELEASE;ORALEQ 25MG TARTRATENoNo
002METOPROLOL SUCCINATEMETOPROLOL SUCCINATETABLET, EXTENDED RELEASE;ORALEQ 50MG TARTRATENoNo
003METOPROLOL SUCCINATEMETOPROLOL SUCCINATETABLET, EXTENDED RELEASE;ORALEQ 100MG TARTRATENoNo
004METOPROLOL SUCCINATEMETOPROLOL SUCCINATETABLET, EXTENDED RELEASE;ORALEQ 200MG TARTRATENoNo

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

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A204161-001METOPROLOL SUCCINATEMETOPROLOL SUCCINATEEQ 25MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2016-11-25
A204161-002METOPROLOL SUCCINATEMETOPROLOL SUCCINATEEQ 50MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2016-11-25
A204161-003METOPROLOL SUCCINATEMETOPROLOL SUCCINATEEQ 100MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2016-11-25
A204161-004METOPROLOL SUCCINATEMETOPROLOL SUCCINATEEQ 200MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2016-11-25

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-productTE code
A204161-001AB
A204161-002AB
A204161-003AB
A204161-004AB

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 5 · 164 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A204161-001METOPROLOL SUCCINATEEQ 25MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2016-11-25011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204161-002METOPROLOL SUCCINATEEQ 50MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2016-11-25011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204161-003METOPROLOL SUCCINATEEQ 100MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2016-11-25011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204161-004METOPROLOL SUCCINATEEQ 200MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2016-11-25011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204161-001METOPROLOL SUCCINATEEQ 25MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2016-11-2531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204161-002METOPROLOL SUCCINATEEQ 50MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2016-11-2531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204161-003METOPROLOL SUCCINATEEQ 100MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2016-11-2531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204161-004METOPROLOL SUCCINATEEQ 200MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2016-11-2531067a03dcf5…
2025-08-23 18:47 UTC2025-08A204161-001METOPROLOL SUCCINATEEQ 25MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2016-11-256a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204161-002METOPROLOL SUCCINATEEQ 50MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2016-11-256a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204161-003METOPROLOL SUCCINATEEQ 100MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2016-11-256a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204161-004METOPROLOL SUCCINATEEQ 200MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2016-11-256a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204161-001METOPROLOL SUCCINATEEQ 25MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2016-11-25fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204161-002METOPROLOL SUCCINATEEQ 50MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2016-11-25fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204161-003METOPROLOL SUCCINATEEQ 100MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2016-11-25fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204161-004METOPROLOL SUCCINATEEQ 200MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2016-11-25fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204161-001METOPROLOL SUCCINATEEQ 25MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2016-11-25b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204161-002METOPROLOL SUCCINATEEQ 50MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2016-11-25b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204161-003METOPROLOL SUCCINATEEQ 100MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2016-11-25b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204161-004METOPROLOL SUCCINATEEQ 200MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2016-11-25b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204161-001METOPROLOL SUCCINATEEQ 25MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2016-11-2503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204161-002METOPROLOL SUCCINATEEQ 50MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2016-11-2503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204161-003METOPROLOL SUCCINATEEQ 100MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2016-11-2503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204161-004METOPROLOL SUCCINATEEQ 200MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2016-11-2503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204161-001METOPROLOL SUCCINATEEQ 25MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2016-11-252680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204161-002METOPROLOL SUCCINATEEQ 50MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2016-11-252680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204161-003METOPROLOL SUCCINATEEQ 100MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2016-11-252680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204161-004METOPROLOL SUCCINATEEQ 200MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2016-11-252680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204161-001METOPROLOL SUCCINATEEQ 25MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2016-11-255bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204161-002METOPROLOL SUCCINATEEQ 50MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2016-11-255bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204161-003METOPROLOL SUCCINATEEQ 100MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2016-11-255bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204161-004METOPROLOL SUCCINATEEQ 200MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2016-11-255bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204161-001METOPROLOL SUCCINATEEQ 25MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2016-11-25d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204161-002METOPROLOL SUCCINATEEQ 50MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2016-11-25d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204161-003METOPROLOL SUCCINATEEQ 100MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2016-11-25d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204161-004METOPROLOL SUCCINATEEQ 200MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2016-11-25d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A204161-001METOPROLOL SUCCINATEEQ 25MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2016-11-25d06236e962d9…
2024-10-29 15:01 UTC2024-10A204161-002METOPROLOL SUCCINATEEQ 50MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2016-11-25d06236e962d9…
2024-10-29 15:01 UTC2024-10A204161-003METOPROLOL SUCCINATEEQ 100MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2016-11-25d06236e962d9…
2024-10-29 15:01 UTC2024-10A204161-004METOPROLOL SUCCINATEEQ 200MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2016-11-25d06236e962d9…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 148 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A204161-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204161-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204161-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204161-004AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204161-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204161-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204161-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204161-004AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A204161-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204161-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204161-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204161-004AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204161-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204161-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204161-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204161-004AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204161-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204161-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204161-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204161-004AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204161-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204161-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204161-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204161-004AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204161-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204161-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204161-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204161-004AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204161-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204161-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204161-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204161-004AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204161-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204161-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204161-003AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204161-004AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A204161-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A204161-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A204161-003AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A204161-004AB1d06236e962d9…

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 · 6 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
metoprolol succinateMETOPROLOL SUCCINATENorthwind Health Company, LLCf2b4b132-54a5-c875-e053-2a95a90af4432026-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204161
application number: ANDA204161
metoprolol succinateMETOPROLOL SUCCINATENorthwind Health Company, LLCf3192894-6298-1b54-e053-2995a90ab2e02026-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204161
application number: ANDA204161
metoprolol succinateMETOPROLOL SUCCINATENorthwind Health Company, LLCf76d782a-59fe-2093-e053-6394a90a86682026-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204161
application number: ANDA204161
metoprolol succinateMETOPROLOL SUCCINATEActavis Pharma, Inc.b798601e-a369-4c8b-8235-08900e1b751d2024-12-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204161
application number: ANDA204161
ndc (product): 45963-678
ndc (product): 45963-709
ndc (product): 45963-676
ndc (product): 45963-677
metoprolol succinateMETOPROLOL SUCCINATEProficient Rx LP57e33bcf-b380-44bb-b96e-3a637af6233a2023-05-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204161
application number: ANDA204161
metoprolol succinateMETOPROLOL SUCCINATEProficient Rx LP64c65611-d5c9-4802-9edd-32c7c67ce6f42023-05-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204161
application number: ANDA204161
ndc (product): 71205-368

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 44 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
45963-676metoprolol succinatemetoprolol succinateActavis Pharma, Inc.ANDACurrent
45963-676metoprolol succinatemetoprolol succinateActavis Pharma, Inc.ANDACurrent
45963-676metoprolol succinatemetoprolol succinateActavis Pharma, Inc.ANDACurrent
45963-676metoprolol succinatemetoprolol succinateActavis Pharma, Inc.ANDACurrent
45963-676metoprolol succinatemetoprolol succinateActavis Pharma, Inc.ANDACurrent
45963-676metoprolol succinatemetoprolol succinateActavis Pharma, Inc.ANDACurrent
45963-676metoprolol succinatemetoprolol succinateActavis Pharma, Inc.ANDACurrent
45963-677metoprolol succinatemetoprolol succinateActavis Pharma, Inc.ANDACurrent
45963-677metoprolol succinatemetoprolol succinateActavis Pharma, Inc.ANDACurrent
45963-677metoprolol succinatemetoprolol succinateActavis Pharma, Inc.ANDACurrent
45963-677metoprolol succinatemetoprolol succinateActavis Pharma, Inc.ANDACurrent
45963-677metoprolol succinatemetoprolol succinateActavis Pharma, Inc.ANDACurrent
45963-677metoprolol succinatemetoprolol succinateActavis Pharma, Inc.ANDACurrent
45963-677metoprolol succinatemetoprolol succinateActavis Pharma, Inc.ANDACurrent
45963-677metoprolol succinatemetoprolol succinateActavis Pharma, Inc.ANDACurrent
45963-677metoprolol succinatemetoprolol succinateActavis Pharma, Inc.ANDACurrent
45963-678metoprolol succinatemetoprolol succinateActavis Pharma, Inc.ANDACurrent
45963-678metoprolol succinatemetoprolol succinateActavis Pharma, Inc.ANDACurrent
45963-678metoprolol succinatemetoprolol succinateActavis Pharma, Inc.ANDACurrent
45963-678metoprolol succinatemetoprolol succinateActavis Pharma, Inc.ANDACurrent
45963-678metoprolol succinatemetoprolol succinateActavis Pharma, Inc.ANDACurrent
45963-678metoprolol succinatemetoprolol succinateActavis Pharma, Inc.ANDACurrent
45963-678metoprolol succinatemetoprolol succinateActavis Pharma, Inc.ANDACurrent
45963-678metoprolol succinatemetoprolol succinateActavis Pharma, Inc.ANDACurrent
45963-678metoprolol succinatemetoprolol succinateActavis Pharma, Inc.ANDACurrent
45963-709metoprolol succinatemetoprolol succinateActavis Pharma, Inc.ANDACurrent
45963-709metoprolol succinatemetoprolol succinateActavis Pharma, Inc.ANDACurrent
45963-709metoprolol succinatemetoprolol succinateActavis Pharma, Inc.ANDACurrent
45963-709metoprolol succinatemetoprolol succinateActavis Pharma, Inc.ANDACurrent
45963-709metoprolol succinatemetoprolol succinateActavis Pharma, Inc.ANDACurrent
45963-709metoprolol succinatemetoprolol succinateActavis Pharma, Inc.ANDACurrent
45963-709metoprolol succinatemetoprolol succinateActavis Pharma, Inc.ANDACurrent
45963-709metoprolol succinatemetoprolol succinateActavis Pharma, Inc.ANDACurrent
45963-709metoprolol succinatemetoprolol succinateActavis Pharma, Inc.ANDACurrent
50090-5394metoprolol succinatemetoprolol succinateA-S Medication SolutionsANDACurrent
50090-5394metoprolol succinatemetoprolol succinateA-S Medication SolutionsANDACurrent
50090-5395metoprolol succinatemetoprolol succinateA-S Medication SolutionsANDACurrent
50090-5413metoprolol succinatemetoprolol succinateA-S Medication SolutionsANDACurrent
50090-5413metoprolol succinatemetoprolol succinateA-S Medication SolutionsANDACurrent
53002-2612metoprolol succinatemetoprolol succinateRPK Pharmaceuticals, Inc.ANDACurrent
53002-2781metoprolol succinatemetoprolol succinateRPK Pharmaceuticals, Inc.ANDACurrent
70518-2770metoprolol succinatemetoprolol succinateREMEDYREPACK INC.ANDACurrent
70518-2770metoprolol succinatemetoprolol succinateREMEDYREPACK INC.ANDACurrent
71205-368metoprolol succinatemetoprolol succinateProficient Rx LPANDACurrent