Application 203894

Type
ANDA
Sponsor
ZYDUS PHARMS

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 43.

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
A203894-001METOPROLOL SUCCINATEMETOPROLOL SUCCINATEEQ 25MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2018-03-23
A203894-002METOPROLOL SUCCINATEMETOPROLOL SUCCINATEEQ 50MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2018-03-23
A203894-003METOPROLOL SUCCINATEMETOPROLOL SUCCINATEEQ 100MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2018-03-23
A203894-004METOPROLOL SUCCINATEMETOPROLOL SUCCINATEEQ 200MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2018-03-23

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A203894-001AB
A203894-002AB
A203894-003AB
A203894-004AB

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 · 172 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A203894-001METOPROLOL SUCCINATEEQ 25MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2018-03-2384e616aacf4f…
2026-09-14 22:38:342026-08A203894-002METOPROLOL SUCCINATEEQ 50MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2018-03-2384e616aacf4f…
2026-09-14 22:38:342026-08A203894-003METOPROLOL SUCCINATEEQ 100MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2018-03-2384e616aacf4f…
2026-09-14 22:38:342026-08A203894-004METOPROLOL SUCCINATEEQ 200MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2018-03-2384e616aacf4f…
2026-08-18 06:07:402026-07A203894-001METOPROLOL SUCCINATEEQ 25MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2018-03-23caaa826d4ba7…
2026-08-18 06:07:402026-07A203894-002METOPROLOL SUCCINATEEQ 50MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2018-03-23caaa826d4ba7…
2026-08-18 06:07:402026-07A203894-003METOPROLOL SUCCINATEEQ 100MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2018-03-23caaa826d4ba7…
2026-08-18 06:07:402026-07A203894-004METOPROLOL SUCCINATEEQ 200MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2018-03-23caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A203894-001METOPROLOL SUCCINATEEQ 25MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2018-03-23011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203894-002METOPROLOL SUCCINATEEQ 50MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2018-03-23011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203894-003METOPROLOL SUCCINATEEQ 100MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2018-03-23011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203894-004METOPROLOL SUCCINATEEQ 200MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2018-03-23011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203894-001METOPROLOL SUCCINATEEQ 25MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2018-03-2331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203894-002METOPROLOL SUCCINATEEQ 50MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2018-03-2331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203894-003METOPROLOL SUCCINATEEQ 100MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2018-03-2331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203894-004METOPROLOL SUCCINATEEQ 200MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2018-03-2331067a03dcf5…
2025-08-23 18:47 UTC2025-08A203894-001METOPROLOL SUCCINATEEQ 25MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2018-03-236a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203894-002METOPROLOL SUCCINATEEQ 50MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2018-03-236a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203894-003METOPROLOL SUCCINATEEQ 100MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2018-03-236a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203894-004METOPROLOL SUCCINATEEQ 200MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2018-03-236a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203894-001METOPROLOL SUCCINATEEQ 25MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2018-03-23fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203894-002METOPROLOL SUCCINATEEQ 50MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2018-03-23fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203894-003METOPROLOL SUCCINATEEQ 100MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2018-03-23fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203894-004METOPROLOL SUCCINATEEQ 200MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2018-03-23fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203894-001METOPROLOL SUCCINATEEQ 25MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2018-03-23b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203894-002METOPROLOL SUCCINATEEQ 50MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2018-03-23b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203894-003METOPROLOL SUCCINATEEQ 100MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2018-03-23b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203894-004METOPROLOL SUCCINATEEQ 200MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2018-03-23b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203894-001METOPROLOL SUCCINATEEQ 25MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2018-03-2303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203894-002METOPROLOL SUCCINATEEQ 50MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2018-03-2303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203894-003METOPROLOL SUCCINATEEQ 100MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2018-03-2303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203894-004METOPROLOL SUCCINATEEQ 200MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2018-03-2303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203894-001METOPROLOL SUCCINATEEQ 25MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2018-03-232680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203894-002METOPROLOL SUCCINATEEQ 50MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2018-03-232680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203894-003METOPROLOL SUCCINATEEQ 100MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2018-03-232680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203894-004METOPROLOL SUCCINATEEQ 200MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2018-03-232680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203894-001METOPROLOL SUCCINATEEQ 25MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2018-03-235bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203894-002METOPROLOL SUCCINATEEQ 50MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2018-03-235bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203894-003METOPROLOL SUCCINATEEQ 100MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2018-03-235bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203894-004METOPROLOL SUCCINATEEQ 200MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2018-03-235bbf6a4d5a75…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 172 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A203894-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A203894-002AB184e616aacf4f…
2026-09-14 22:38:342026-08A203894-003AB184e616aacf4f…
2026-09-14 22:38:342026-08A203894-004AB184e616aacf4f…
2026-08-18 06:07:402026-07A203894-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A203894-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A203894-003AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A203894-004AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A203894-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203894-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203894-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203894-004AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203894-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203894-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203894-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203894-004AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A203894-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203894-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203894-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203894-004AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203894-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203894-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203894-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203894-004AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203894-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203894-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203894-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203894-004AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203894-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203894-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203894-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203894-004AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203894-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203894-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203894-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203894-004AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203894-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203894-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203894-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203894-004AB15bbf6a4d5a75…

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 · 20 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
metoprolol succinateMETOPROLOL SUCCINATEBryant Ranch Prepacka1997b48-8d66-437a-a253-ca996331b0c32026-06-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203894
application number: ANDA203894
metoprolol succinateMETOPROLOL SUCCINATEBryant Ranch Prepackadc8234b-192a-4ca4-a949-3eabc11af5252026-06-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203894
application number: ANDA203894
metoprolol succinateMETOPROLOL SUCCINATEBryant Ranch Prepack9c33fc53-35d1-4b01-a805-ae737405db3f2026-06-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203894
application number: ANDA203894
metoprolol succinateMETOPROLOL SUCCINATEBryant Ranch Prepack6da0e3dc-1b11-4975-b35c-5a6ca13cf9902026-06-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203894
application number: ANDA203894
metoprolol succinateMETOPROLOL SUCCINATEBryant Ranch Prepackd58b56cc-1a3d-4147-afc2-12e8236c37662026-06-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203894
application number: ANDA203894
ndc (product): 71335-1951
metoprolol succinateMETOPROLOL SUCCINATENorthwind Health Company, LLC471bca3e-3401-6814-e063-6394a90a9cb12026-06-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203894
application number: ANDA203894
metoprolol succinateMETOPROLOL SUCCINATEREMEDYREPACK INC.c2eb2a77-761a-49c0-9eca-8eb57d8532d22026-06-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203894
application number: ANDA203894
metoprolol succinateMETOPROLOL SUCCINATESt. Mary's Medical Park Pharmacy0a99ed82-2ee8-6f9c-e063-6394a90ac7ba2026-06-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203894
application number: ANDA203894
metoprolol succinateMETOPROLOL SUCCINATESt Mary's Medical Park Pharmacycdb69427-0489-3751-e053-2995a90a36672026-06-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203894
application number: ANDA203894
metoprolol succinateMETOPROLOL SUCCINATEREMEDYREPACK INC.ea67ed64-47df-4728-8e62-c5d7316a71aa2026-05-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203894
application number: ANDA203894
metoprolol succinateMETOPROLOL SUCCINATEREMEDYREPACK INC.eea82ccb-876b-4fe8-9270-dcea509029a52026-05-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203894
application number: ANDA203894
metoprolol succinateMETOPROLOL SUCCINATEZydus Pharmaceuticals (USA) Inc.bd77ec6e-c58c-440b-81d6-8a462b2fdc9c2026-05-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203894
application number: ANDA203894
metoprolol succinateMETOPROLOL SUCCINATEZydus Lifesciences Limited1098f26d-8319-4dba-ad66-3df22db2b3992026-05-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203894
application number: ANDA203894
metoprolol succinateMETOPROLOL SUCCINATEA-S Medication Solutionscbc32a80-717b-4cf2-b76a-6d03a37204192025-05-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203894
application number: ANDA203894
metoprolol succinateMETOPROLOL SUCCINATEProficient Rx LPe29d6ea1-1374-4572-ad7e-b0c2ea48ca042025-02-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203894
application number: ANDA203894
metoprolol succinateMETOPROLOL SUCCINATERedpharm Drug0b25ce23-6d78-bc88-e063-6294a90abb782025-01-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203894
application number: ANDA203894
metoprolol succinateMETOPROLOL SUCCINATEA-S Medication Solutions712e8b44-c659-4344-8550-ce43f94223002024-12-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203894
application number: ANDA203894
metoprolol succinateMETOPROLOL SUCCINATENuCare Pharmaceuticals,Inc.ca8dbdc1-0137-8a89-e053-2995a90a66fd2024-07-30Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203894
application number: ANDA203894
Metoprolol Succinate ERMETOPROLOL SUCCINATE ERDirect_Rx15d5c223-af4e-e803-e063-6294a90af3d82024-04-11Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203894
application number: ANDA203894
metoprolol succinateMETOPROLOL SUCCINATENuCare Pharmaceuticals,Inc.d96a039f-c3e5-4749-e053-2995a90abcb22024-03-25Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203894
application number: ANDA203894

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 2 of 2 · 81 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
71335-1951metoprolol succinatemetoprolol succinateBryant Ranch PrepackANDACurrent