Home Applications 202033 Application 202033
Type ANDA
Sponsor MYLAN PHARMS INC Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 METOPROLOL SUCCINATE METOPROLOL SUCCINATE TABLET, EXTENDED RELEASE;ORAL EQ 25MG TARTRATE No No 002 METOPROLOL SUCCINATE METOPROLOL SUCCINATE TABLET, EXTENDED RELEASE;ORAL EQ 50MG TARTRATE No No 003 METOPROLOL SUCCINATE METOPROLOL SUCCINATE TABLET, EXTENDED RELEASE;ORAL EQ 100MG TARTRATE No No 004 METOPROLOL SUCCINATE METOPROLOL SUCCINATE TABLET, EXTENDED RELEASE;ORAL EQ 200MG TARTRATE No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
Orange Book products# Current product rows page 1 of 1 · 4 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A202033-001 METOPROLOL SUCCINATE METOPROLOL SUCCINATE EQ 25MG TARTRATE TABLET, EXTENDED RELEASE / ORAL 2011-12-15 A202033-002 METOPROLOL SUCCINATE METOPROLOL SUCCINATE EQ 50MG TARTRATE TABLET, EXTENDED RELEASE / ORAL 2011-12-15 A202033-003 METOPROLOL SUCCINATE METOPROLOL SUCCINATE EQ 100MG TARTRATE TABLET, EXTENDED RELEASE / ORAL 2011-12-15 A202033-004 METOPROLOL SUCCINATE METOPROLOL SUCCINATE EQ 200MG TARTRATE TABLET, EXTENDED RELEASE / ORAL 2011-12-15
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 5 of 5 · 176 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2022-10-28 04:53 UTC 2022-10 A202033-001 METOPROLOL SUCCINATE EQ 25MG TARTRATE TABLET, EXTENDED RELEASE / ORAL AB 2011-12-15 f41ea6bd6efb…2022-10-28 04:53 UTC 2022-10 A202033-002 METOPROLOL SUCCINATE EQ 50MG TARTRATE TABLET, EXTENDED RELEASE / ORAL AB 2011-12-15 f41ea6bd6efb…2022-10-28 04:53 UTC 2022-10 A202033-003 METOPROLOL SUCCINATE EQ 100MG TARTRATE TABLET, EXTENDED RELEASE / ORAL AB 2011-12-15 f41ea6bd6efb…2022-10-28 04:53 UTC 2022-10 A202033-004 METOPROLOL SUCCINATE EQ 200MG TARTRATE TABLET, EXTENDED RELEASE / ORAL AB 2011-12-15 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A202033-001 METOPROLOL SUCCINATE EQ 25MG TARTRATE TABLET, EXTENDED RELEASE / ORAL AB 2011-12-15 e64feba35796…2022-09-29 23:25 UTC 2022-09 A202033-002 METOPROLOL SUCCINATE EQ 50MG TARTRATE TABLET, EXTENDED RELEASE / ORAL AB 2011-12-15 e64feba35796…2022-09-29 23:25 UTC 2022-09 A202033-003 METOPROLOL SUCCINATE EQ 100MG TARTRATE TABLET, EXTENDED RELEASE / ORAL AB 2011-12-15 e64feba35796…2022-09-29 23:25 UTC 2022-09 A202033-004 METOPROLOL SUCCINATE EQ 200MG TARTRATE TABLET, EXTENDED RELEASE / ORAL AB 2011-12-15 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A202033-001 METOPROLOL SUCCINATE EQ 25MG TARTRATE TABLET, EXTENDED RELEASE / ORAL AB 2011-12-15 cb3db0bc1861…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A202033-002 METOPROLOL SUCCINATE EQ 50MG TARTRATE TABLET, EXTENDED RELEASE / ORAL AB 2011-12-15 cb3db0bc1861…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A202033-003 METOPROLOL SUCCINATE EQ 100MG TARTRATE TABLET, EXTENDED RELEASE / ORAL AB 2011-12-15 cb3db0bc1861…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A202033-004 METOPROLOL SUCCINATE EQ 200MG TARTRATE TABLET, EXTENDED RELEASE / ORAL AB 2011-12-15 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A202033-001 METOPROLOL SUCCINATE EQ 25MG TARTRATE TABLET, EXTENDED RELEASE / ORAL 2011-12-15 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A202033-002 METOPROLOL SUCCINATE EQ 50MG TARTRATE TABLET, EXTENDED RELEASE / ORAL 2011-12-15 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A202033-003 METOPROLOL SUCCINATE EQ 100MG TARTRATE TABLET, EXTENDED RELEASE / ORAL 2011-12-15 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A202033-004 METOPROLOL SUCCINATE EQ 200MG TARTRATE TABLET, EXTENDED RELEASE / ORAL 2011-12-15 a50c72e98297…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 160 observed states.
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 9 · 172 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Metoprolol Succinate METOPROLOL SUCCINATE REMEDYREPACK INC. a46cbf09-20e3-4f0d-ab41-221f60fde068 2026-09-16 Warnings, Adverse reactions Name fallback brand name: Metoprolol Succinate generic name: METOPROLOL SUCCINATE Metoprolol Succinate METOPROLOL SUCCINATE Granules India Ltd c5431c8a-d92c-489e-b63b-4b9cc8f32a1a 2026-09-04 Warnings, Adverse reactions Name fallback brand name: Metoprolol Succinate generic name: METOPROLOL SUCCINATE Metoprolol succinate METOPROLOL SUCCINATE Redpharm Drug 5a65a60c-4c0d-e89b-e063-6394a90ac689 2026-09-01 Warnings, Adverse reactions Name fallback brand name: Metoprolol succinate generic name: METOPROLOL SUCCINATE Metoprolol Succinate METOPROLOL SUCCINATE REMEDYREPACK INC. 565bcddd-0720-484b-9316-d8fc0dc3ffab 2026-08-31 Warnings, Adverse reactions Name fallback brand name: Metoprolol Succinate generic name: METOPROLOL SUCCINATE Metoprolol Succinate METOPROLOL SUCCINATE ER TABLETS REMEDYREPACK INC. 76c69d7c-e90c-4f96-a45b-e9dad9444263 2026-08-31 Warnings, Adverse reactions Name fallback brand name: Metoprolol Succinate Metoprolol Succinate METOPROLOL SUCCINATE REMEDYREPACK INC. c1d1726f-75c6-4c07-b5ff-565c4c4ca904 2026-08-27 Warnings, Adverse reactions Name fallback brand name: Metoprolol Succinate generic name: METOPROLOL SUCCINATE Metoprolol succinate METOPROLOL SUCCINATE Redpharm Drug 59ed0d9a-54c8-4c13-e063-6394a90a2aaa 2026-08-26 Warnings, Adverse reactions Name fallback brand name: Metoprolol succinate generic name: METOPROLOL SUCCINATE Metoprolol Succinate METOPROLOL SUCCINATE ER TABLETS REMEDYREPACK INC. 28c22fb6-6cc9-4c41-b781-88b33b6c8cee 2026-08-14 Warnings, Adverse reactions Name fallback brand name: Metoprolol Succinate Metoprolol succinate METOPROLOL SUCCINATE Redpharm Drug 58be9439-7943-3e41-e063-6394a90adddc 2026-08-11 Warnings, Adverse reactions Name fallback brand name: Metoprolol succinate generic name: METOPROLOL SUCCINATE Metoprolol succinate METOPROLOL SUCCINATE Bryant Ranch Prepack a693bef9-cdfa-4012-ac87-873b9c5bf1cd 2026-08-04 Warnings, Adverse reactions Name fallback brand name: Metoprolol succinate generic name: METOPROLOL SUCCINATE Metoprolol Succinate METOPROLOL SUCCINATE Proficient Rx LP f2d7c4da-9df0-44d4-9db3-e47e9cce9254 2026-08-01 Warnings, Adverse reactions Name fallback brand name: Metoprolol Succinate generic name: METOPROLOL SUCCINATE Metoprolol Succinate METOPROLOL SUCCINATE ER TABLETS BluePoint Laboratories 6588d77c-090f-4722-9c91-437887d4624a 2026-07-10 Warnings, Adverse reactions Name fallback brand name: Metoprolol Succinate Metoprolol succinate METOPROLOL SUCCINATE Aphena Pharma Solutions - Tennessee, LLC 52bdc5cc-973f-4af6-e063-6294a90aba22 2026-07-10 Warnings, Adverse reactions Name fallback brand name: Metoprolol succinate generic name: METOPROLOL SUCCINATE Metoprolol succinate METOPROLOL SUCCINATE Coupler LLC 55f1a53b-8ec1-8373-e063-6394a90a896c 2026-07-06 Warnings, Adverse reactions Name fallback brand name: Metoprolol succinate generic name: METOPROLOL SUCCINATE METOPROLOL SUCCINATE METOPROLOL SUCCINATE Coupler LLC 55f20cc3-d958-bd74-e063-6394a90a7850 2026-07-06 Warnings, Adverse reactions Name fallback brand name: METOPROLOL SUCCINATE generic name: METOPROLOL SUCCINATE Metoprolol Succinate METOPROLOL SUCCINATE Coupler LLC 55f47fad-ddc9-d9e6-e063-6394a90a48cf 2026-07-06 Warnings, Adverse reactions Name fallback brand name: Metoprolol Succinate generic name: METOPROLOL SUCCINATE Metoprolol Succinate METOPROLOL SUCCINATE PD-Rx Pharmaceuticals, Inc. 98a39051-be63-4120-b247-50796656bd7c 2026-07-02 Warnings, Adverse reactions Name fallback brand name: Metoprolol Succinate generic name: METOPROLOL SUCCINATE Metoprolol Succinate METOPROLOL SUCCINATE American Health Packaging 74e3b4dc-eb30-4d7c-a558-cf58f6470496 2026-06-30 Warnings, Adverse reactions Name fallback brand name: Metoprolol Succinate generic name: METOPROLOL SUCCINATE metoprolol succinate METOPROLOL SUCCINATE Bryant Ranch Prepack a1997b48-8d66-437a-a253-ca996331b0c3 2026-06-29 Warnings, Adverse reactions Name fallback brand name: metoprolol succinate generic name: METOPROLOL SUCCINATE metoprolol succinate METOPROLOL SUCCINATE Bryant Ranch Prepack adc8234b-192a-4ca4-a949-3eabc11af525 2026-06-29 Warnings, Adverse reactions Name fallback brand name: metoprolol succinate generic name: METOPROLOL SUCCINATE
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 · 29 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0378-4595 Metoprolol Succinate metoprolol succinate Mylan Pharmaceuticals Inc. ANDA Current 0378-4595 Metoprolol Succinate metoprolol succinate Mylan Pharmaceuticals Inc. ANDA Current 0378-4595 Metoprolol Succinate metoprolol succinate Mylan Pharmaceuticals Inc. ANDA Current 0378-4596 Metoprolol Succinate metoprolol succinate Mylan Pharmaceuticals Inc. ANDA Current 0378-4596 Metoprolol Succinate metoprolol succinate Mylan Pharmaceuticals Inc. ANDA Current 0378-4596 Metoprolol Succinate metoprolol succinate Mylan Pharmaceuticals Inc. ANDA Current 0378-4597 Metoprolol Succinate metoprolol succinate Mylan Pharmaceuticals Inc. ANDA Current 0378-4597 Metoprolol Succinate metoprolol succinate Mylan Pharmaceuticals Inc. ANDA Current 0378-4597 Metoprolol Succinate metoprolol succinate Mylan Pharmaceuticals Inc. ANDA Current 0378-4598 Metoprolol Succinate metoprolol succinate Mylan Pharmaceuticals Inc. ANDA Current 0378-4598 Metoprolol Succinate metoprolol succinate Mylan Pharmaceuticals Inc. ANDA Current 0378-4598 Metoprolol Succinate metoprolol succinate Mylan Pharmaceuticals Inc. ANDA Current 51079-169 Metoprolol Succinate metoprolol succinate Mylan Institutional Inc. ANDA Current 51079-169 Metoprolol Succinate metoprolol succinate Mylan Institutional ANDA Current 51079-169 Metoprolol Succinate metoprolol succinate Mylan Institutional Inc. ANDA Current 51079-169 Metoprolol Succinate metoprolol succinate Mylan Institutional Inc. ANDA Current 51079-170 Metoprolol Succinate metoprolol succinate Mylan Institutional Inc. ANDA Current 51079-170 Metoprolol Succinate metoprolol succinate Mylan Institutional ANDA Current 51079-170 Metoprolol Succinate metoprolol succinate Mylan Institutional Inc. ANDA Current 51079-170 Metoprolol Succinate metoprolol succinate Mylan Institutional Inc. ANDA Current 51079-171 Metoprolol Succinate metoprolol succinate Mylan Institutional ANDA Current 51079-171 Metoprolol Succinate metoprolol succinate Mylan Institutional Inc. ANDA Current 51079-171 Metoprolol Succinate metoprolol succinate Mylan Institutional Inc. ANDA Current 55154-4385 Metoprolol Succinate metoprolol succinate Cardinal Health ANDA Current 55154-4385 Metoprolol Succinate metoprolol succinate Cardinal Health ANDA Current 55154-4385 Metoprolol Succinate metoprolol succinate Cardinal Health ANDA Current 55154-4388 Metoprolol Succinate metoprolol succinate Cardinal Health ANDA Current 55154-4388 Metoprolol Succinate metoprolol succinate Cardinal Health ANDA Current 55154-4388 Metoprolol Succinate metoprolol succinate Cardinal Health ANDA Current