Application 078889

Type
ANDA
Sponsor
REDDYS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001METOPROLOL SUCCINATEMETOPROLOL SUCCINATETABLET, EXTENDED RELEASE;ORALEQ 100MG TARTRATENoNo
002METOPROLOL 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 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A078889-001METOPROLOL SUCCINATEMETOPROLOL SUCCINATEEQ 100MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2012-08-15
A078889-002METOPROLOL SUCCINATEMETOPROLOL SUCCINATEEQ 200MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2012-08-15

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A078889-001AB
A078889-002AB

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 · 86 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A078889-001METOPROLOL SUCCINATEEQ 100MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2012-08-1584e616aacf4f…
2026-09-14 22:38:342026-08A078889-002METOPROLOL SUCCINATEEQ 200MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2012-08-1584e616aacf4f…
2026-08-18 06:07:402026-07A078889-001METOPROLOL SUCCINATEEQ 100MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2012-08-15caaa826d4ba7…
2026-08-18 06:07:402026-07A078889-002METOPROLOL SUCCINATEEQ 200MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2012-08-15caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A078889-001METOPROLOL SUCCINATEEQ 100MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2012-08-15011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078889-002METOPROLOL SUCCINATEEQ 200MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2012-08-15011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078889-001METOPROLOL SUCCINATEEQ 100MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2012-08-1531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078889-002METOPROLOL SUCCINATEEQ 200MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2012-08-1531067a03dcf5…
2025-08-23 18:47 UTC2025-08A078889-001METOPROLOL SUCCINATEEQ 100MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2012-08-156a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078889-002METOPROLOL SUCCINATEEQ 200MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2012-08-156a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078889-001METOPROLOL SUCCINATEEQ 100MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2012-08-15fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078889-002METOPROLOL SUCCINATEEQ 200MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2012-08-15fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078889-001METOPROLOL SUCCINATEEQ 100MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2012-08-15b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078889-002METOPROLOL SUCCINATEEQ 200MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2012-08-15b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078889-001METOPROLOL SUCCINATEEQ 100MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2012-08-1503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078889-002METOPROLOL SUCCINATEEQ 200MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2012-08-1503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078889-001METOPROLOL SUCCINATEEQ 100MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2012-08-152680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078889-002METOPROLOL SUCCINATEEQ 200MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2012-08-152680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078889-001METOPROLOL SUCCINATEEQ 100MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2012-08-155bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078889-002METOPROLOL SUCCINATEEQ 200MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2012-08-155bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078889-001METOPROLOL SUCCINATEEQ 100MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2012-08-15d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078889-002METOPROLOL SUCCINATEEQ 200MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2012-08-15d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A078889-001METOPROLOL SUCCINATEEQ 100MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2012-08-15d06236e962d9…
2024-10-29 15:01 UTC2024-10A078889-002METOPROLOL SUCCINATEEQ 200MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2012-08-15d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078889-001METOPROLOL SUCCINATEEQ 100MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2012-08-1579d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078889-002METOPROLOL SUCCINATEEQ 200MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2012-08-1579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078889-001METOPROLOL SUCCINATEEQ 100MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2012-08-15301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078889-002METOPROLOL SUCCINATEEQ 200MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2012-08-15301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078889-001METOPROLOL SUCCINATEEQ 100MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2012-08-151e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078889-002METOPROLOL SUCCINATEEQ 200MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2012-08-151e350fbaab3a…
2024-05-31 18:47 UTC2024-05A078889-001METOPROLOL SUCCINATEEQ 100MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2012-08-158072bd15b7f6…
2024-05-31 18:47 UTC2024-05A078889-002METOPROLOL SUCCINATEEQ 200MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2012-08-158072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A078889-001METOPROLOL SUCCINATEEQ 100MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2012-08-155c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A078889-002METOPROLOL SUCCINATEEQ 200MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2012-08-155c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A078889-001METOPROLOL SUCCINATEEQ 100MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2012-08-155d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A078889-002METOPROLOL SUCCINATEEQ 200MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2012-08-155d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A078889-001METOPROLOL SUCCINATEEQ 100MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2012-08-154b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A078889-002METOPROLOL SUCCINATEEQ 200MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2012-08-154b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A078889-001METOPROLOL SUCCINATEEQ 100MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2012-08-1574a2ff9319b5…
2019-12-13 00:20 UTC2019-12A078889-002METOPROLOL SUCCINATEEQ 200MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2012-08-1574a2ff9319b5…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 86 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A078889-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A078889-002AB184e616aacf4f…
2026-08-18 06:07:402026-07A078889-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A078889-002AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A078889-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078889-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078889-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078889-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A078889-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078889-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078889-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078889-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078889-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078889-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078889-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078889-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078889-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078889-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078889-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078889-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078889-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078889-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A078889-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A078889-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078889-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078889-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078889-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078889-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078889-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078889-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A078889-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A078889-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A078889-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A078889-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A078889-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A078889-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A078889-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A078889-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A078889-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A078889-002AB174a2ff9319b5…

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 2 of 2 · 22 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Metoprolol succinateMETOPROLOL SUCCINATEProficient Rx LP8e39601f-ada5-4ef7-9b53-083cffec79ec2020-02-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078889
application number: ANDA078889
ndc (product): 63187-768
Metoprolol succinateMETOPROLOL SUCCINATEBluePoint Laboratories5ef12832-15cd-40f4-bf11-6cea7e48ff7f2019-03-26Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078889
application number: ANDA078889
ndc (product): 68001-120
ndc (product): 68001-119

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 1 of 1 · 66 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0615-7825Metoprolol succinateMetoprolol succinateNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-7825Metoprolol succinateMetoprolol succinateNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-7825Metoprolol succinateMetoprolol succinateNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0904-6324Metoprolol succinateMetoprolol succinateMajor PharmaceuticalsANDACurrent
0904-6324Metoprolol succinateMetoprolol succinateMajor PharmaceuticalsANDACurrent
0904-6324Metoprolol succinateMetoprolol succinateMajor PharmaceuticalsANDACurrent
0904-6324Metoprolol succinateMetoprolol succinateMajor PharmaceuticalsANDACurrent
43063-841Metoprolol succinateMetoprolol succinatePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-841Metoprolol succinateMetoprolol succinatePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-841Metoprolol succinateMetoprolol succinatePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-841Metoprolol succinateMetoprolol succinatePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-841Metoprolol succinateMetoprolol succinatePD-Rx Pharmaceuticals, Inc.ANDACurrent
50268-542Metoprolol succinateMetoprolol succinateAvPAKANDACurrent
50268-542Metoprolol succinateMetoprolol succinateAvPAKANDACurrent
50268-542Metoprolol succinateMetoprolol succinateAvPAKANDACurrent
50268-542Metoprolol succinateMetoprolol succinateAvPAKANDACurrent
50268-542Metoprolol succinateMetoprolol succinateAvPAKANDACurrent
50268-543Metoprolol succinateMetoprolol succinateAvPAKANDACurrent
50268-543Metoprolol succinateMetoprolol succinateAvPAKANDACurrent
50268-543Metoprolol succinateMetoprolol succinateAvPAKANDACurrent
50268-543Metoprolol succinateMetoprolol succinateAvPAKANDACurrent
50268-543Metoprolol succinateMetoprolol succinateAvPAKANDACurrent
51655-573Metoprolol Succinate ERMetoprolol Succinate ERNorthwind PharmaceuticalsANDACurrent
55111-468Metoprolol succinateMetoprolol succinateDr. Reddy's Laboratories LimitedANDACurrent
55111-468Metoprolol succinateMetoprolol succinateDr. Reddy's Laboratories LimitedANDACurrent
55111-469Metoprolol succinateMetoprolol succinateDr. Reddy's Laboratories LimitedANDACurrent
55111-469Metoprolol succinateMetoprolol succinateDr. Reddy's Laboratories LimitedANDACurrent
55154-7134Metoprolol succinateMetoprolol succinateCardinal HealthANDACurrent
55154-7134Metoprolol succinateMetoprolol succinateCardinal HealthANDACurrent
55154-7279Metoprolol succinateMetoprolol succinateCardinal Health 107, LLCANDACurrent
55154-7279Metoprolol succinateMetoprolol succinateCardinal HealthANDACurrent
55154-7279Metoprolol succinateMetoprolol succinateCardinal HealthANDACurrent
55700-232Metoprolol succinateMetoprolol succinateLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-232Metoprolol succinateMetoprolol succinateLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-232Metoprolol succinateMetoprolol succinateLake Erie Medical DBA Quality Care Products LLCANDACurrent
60687-413Metoprolol SuccinateMetoprolol SuccinateAmerican Health PackagingANDACurrent
60687-413Metoprolol SuccinateMetoprolol SuccinateAmerican Health PackagingANDACurrent
60687-413Metoprolol SuccinateMetoprolol SuccinateAmerican Health PackagingANDACurrent
60687-413Metoprolol SuccinateMetoprolol SuccinateAmerican Health PackagingANDACurrent
60760-468Metoprolol succinateMetoprolol succinateSt. Mary's Medical Park PharmacyANDACurrent
61919-334METOPROLOL SUCCINATEMETOPROLOL SUCCINATEDirect_RxANDACurrent
63187-768Metoprolol succinateMetoprolol succinateProficient Rx LPANDACurrent
63187-768Metoprolol succinateMetoprolol succinateProficient Rx LPANDACurrent
63187-768Metoprolol succinateMetoprolol succinateProficient Rx LPANDACurrent
63629-7153Metoprolol succinateMetoprolol succinateBryant Ranch PrepackANDACurrent
63629-7153Metoprolol succinateMetoprolol succinateBryant Ranch PrepackANDACurrent
68001-119Metoprolol succinateMetoprolol succinateBluePoint LaboratoriesANDACurrent
68001-120Metoprolol succinateMetoprolol succinateBluePoint LaboratoriesANDACurrent
68071-1921Metoprolol succinateMetoprolol succinateNuCare Pharmaceuticals, Inc.ANDACurrent
68071-1921Metoprolol succinateMetoprolol succinateNuCare Pharmaceuticals, Inc.ANDACurrent
68071-1921Metoprolol succinateMetoprolol succinateNuCare Pharmaceuticals, Inc.ANDACurrent
68084-673Metoprolol succinateMetoprolol succinateAmerican Health PackagingANDACurrent
68645-479Metoprolol succinateMetoprolol succinateLegacy Pharmaceutical Packaging, LLCANDACurrent
68645-479Metoprolol succinateMetoprolol succinateLegacy Pharmaceutical Packaging, LLCANDACurrent
68645-479Metoprolol succinateMetoprolol succinateLegacy Pharmaceutical Packaging, LLCANDACurrent
68645-479Metoprolol succinateMetoprolol succinateLegacy Pharmaceutical Packaging, LLCANDACurrent
68788-8255Metoprolol succinateMetoprolol succinatePreferred Pharmaceuticals Inc.ANDACurrent
70518-1642Metoprolol succinateMetoprolol succinateREMEDYREPACK INC.ANDACurrent
70518-1642Metoprolol succinateMetoprolol succinateREMEDYREPACK INC.ANDACurrent
70518-2080Metoprolol succinateMetoprolol succinateREMEDYREPACK INC.ANDACurrent
70934-319Metoprolol succinateMetoprolol succinateDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-319Metoprolol succinateMetoprolol succinateDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-319Metoprolol succinateMetoprolol succinateDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
71335-0167Metoprolol succinateMetoprolol succinateBryant Ranch PrepackANDACurrent
71335-0167Metoprolol succinateMetoprolol succinateBryant Ranch PrepackANDACurrent
71335-0167Metoprolol succinateMetoprolol succinateBryant Ranch PrepackANDACurrent