Application 202870

Type
ANDA
Sponsor
ALEMBIC PHARMS LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDE; METOPROLOL TARTRATETABLET;ORAL25MG;50MGNoNo
002METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDE; METOPROLOL TARTRATETABLET;ORAL25MG;100MGNoNo
003METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDE; METOPROLOL TARTRATETABLET;ORAL50MG;100MGNoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A202870-001METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDE; METOPROLOL TARTRATE25MG;50MGTABLET / ORALAB2013-11-06
A202870-002METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDE; METOPROLOL TARTRATE25MG;100MGTABLET / ORALAB2013-11-06
A202870-003METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDE; METOPROLOL TARTRATE50MG;100MGTABLET / ORALAB2013-11-06

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A202870-001AB
A202870-002AB
A202870-003AB

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 4 · 129 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A202870-001METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE25MG;50MGTABLET / ORALAB2013-11-0684e616aacf4f…
2026-09-14 22:38:342026-08A202870-002METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE25MG;100MGTABLET / ORALAB2013-11-0684e616aacf4f…
2026-09-14 22:38:342026-08A202870-003METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE50MG;100MGTABLET / ORALAB2013-11-0684e616aacf4f…
2026-08-18 06:07:402026-07A202870-001METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE25MG;50MGTABLET / ORALAB2013-11-06caaa826d4ba7…
2026-08-18 06:07:402026-07A202870-002METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE25MG;100MGTABLET / ORALAB2013-11-06caaa826d4ba7…
2026-08-18 06:07:402026-07A202870-003METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE50MG;100MGTABLET / ORALAB2013-11-06caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A202870-001METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE25MG;50MGTABLET / ORALAB2013-11-06011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202870-002METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE25MG;100MGTABLET / ORALABRS2013-11-06011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202870-003METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE50MG;100MGTABLET / ORALAB2013-11-06011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202870-001METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE25MG;50MGTABLET / ORALAB2013-11-0631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202870-002METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE25MG;100MGTABLET / ORALABRS2013-11-0631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202870-003METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE50MG;100MGTABLET / ORALAB2013-11-0631067a03dcf5…
2025-08-23 18:47 UTC2025-08A202870-001METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE25MG;50MGTABLET / ORALAB2013-11-066a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202870-002METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE25MG;100MGTABLET / ORALABRS2013-11-066a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202870-003METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE50MG;100MGTABLET / ORALAB2013-11-066a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202870-001METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE25MG;50MGTABLET / ORALAB2013-11-06fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202870-002METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE25MG;100MGTABLET / ORALABRS2013-11-06fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202870-003METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE50MG;100MGTABLET / ORALAB2013-11-06fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202870-001METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE25MG;50MGTABLET / ORALAB2013-11-06b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202870-002METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE25MG;100MGTABLET / ORALABRS2013-11-06b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202870-003METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE50MG;100MGTABLET / ORALAB2013-11-06b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202870-001METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE25MG;50MGTABLET / ORALAB2013-11-0603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202870-002METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE25MG;100MGTABLET / ORALABRS2013-11-0603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202870-003METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE50MG;100MGTABLET / ORALAB2013-11-0603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202870-001METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE25MG;50MGTABLET / ORALAB2013-11-062680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202870-002METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE25MG;100MGTABLET / ORALABRS2013-11-062680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202870-003METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE50MG;100MGTABLET / ORALAB2013-11-062680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202870-001METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE25MG;50MGTABLET / ORALAB2013-11-065bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202870-002METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE25MG;100MGTABLET / ORALABRS2013-11-065bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202870-003METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE50MG;100MGTABLET / ORALAB2013-11-065bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202870-001METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE25MG;50MGTABLET / ORALAB2013-11-06d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202870-002METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE25MG;100MGTABLET / ORALABRS2013-11-06d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202870-003METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE50MG;100MGTABLET / ORALAB2013-11-06d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A202870-001METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE25MG;50MGTABLET / ORALAB2013-11-06d06236e962d9…
2024-10-29 15:01 UTC2024-10A202870-002METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE25MG;100MGTABLET / ORALABRS2013-11-06d06236e962d9…
2024-10-29 15:01 UTC2024-10A202870-003METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE50MG;100MGTABLET / ORALAB2013-11-06d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202870-001METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE25MG;50MGTABLET / ORALAB2013-11-0679d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202870-002METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE25MG;100MGTABLET / ORALABRS2013-11-0679d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202870-003METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE50MG;100MGTABLET / ORALAB2013-11-0679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202870-001METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE25MG;50MGTABLET / ORALAB2013-11-06301d65b070ca…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 129 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A202870-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A202870-002AB184e616aacf4f…
2026-09-14 22:38:342026-08A202870-003AB184e616aacf4f…
2026-08-18 06:07:402026-07A202870-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A202870-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A202870-003AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A202870-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202870-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202870-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202870-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202870-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202870-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A202870-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202870-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202870-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202870-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202870-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202870-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202870-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202870-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202870-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202870-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202870-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202870-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202870-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202870-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202870-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202870-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202870-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202870-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202870-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202870-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202870-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A202870-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A202870-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A202870-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202870-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202870-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202870-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202870-001AB1301d65b070ca…

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Metoprolol Tartrate and HydrochlorothiazideMETOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDEAlembic Pharmaceuticals Inc.2b77f66f-6891-4977-be8f-7955473d2f922024-01-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202870
application number: ANDA202870
ndc (product): 62332-116
ndc (product): 62332-117
ndc (product): 62332-115
Metoprolol Tartrate and HydrochlorothiazideMETOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDEAlembic Pharmaceuticals Limited538ea34a-1ac3-48c8-b841-43be09285e122023-01-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202870
application number: ANDA202870
ndc (product): 46708-117
ndc (product): 46708-115
ndc (product): 46708-116

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 30 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
13811-669Metoprolol Tartrate and HydrochlorothiazideMetoprolol Tartrate and HydrochlorothiazideTrigen Laboratories, LLCANDACurrent
13811-670Metoprolol Tartrate and HydrochlorothiazideMetoprolol Tartrate and HydrochlorothiazideTrigen Laboratories, LLCANDACurrent
13811-671Metoprolol Tartrate and HydrochlorothiazideMetoprolol Tartrate and HydrochlorothiazideTrigen Laboratories, LLCANDACurrent
46708-115Metoprolol Tartrate and HydrochlorothiazideMetoprolol Tartrate and HydrochlorothiazideAlembic Pharmaceuticals LimitedANDACurrent
46708-115Metoprolol Tartrate and HydrochlorothiazideMetoprolol Tartrate and HydrochlorothiazideAlembic Pharmaceuticals LimitedANDACurrent
46708-116Metoprolol Tartrate and HydrochlorothiazideMetoprolol Tartrate and HydrochlorothiazideAlembic Pharmaceuticals LimitedANDACurrent
46708-116Metoprolol Tartrate and HydrochlorothiazideMetoprolol Tartrate and HydrochlorothiazideAlembic Pharmaceuticals LimitedANDACurrent
46708-117Metoprolol Tartrate and HydrochlorothiazideMetoprolol Tartrate and HydrochlorothiazideAlembic Pharmaceuticals LimitedANDACurrent
46708-117Metoprolol Tartrate and HydrochlorothiazideMetoprolol Tartrate and HydrochlorothiazideAlembic Pharmaceuticals LimitedANDACurrent
62332-115Metoprolol Tartrate and HydrochlorothiazideMetoprolol Tartrate and HydrochlorothiazideAlembic Pharmaceuticals Inc.ANDACurrent
62332-115Metoprolol Tartrate and HydrochlorothiazideMetoprolol Tartrate and HydrochlorothiazideAlembic Pharmaceuticals Inc.ANDACurrent
62332-115Metoprolol Tartrate and HydrochlorothiazideMetoprolol Tartrate and HydrochlorothiazideAlembic Pharmaceuticals Inc.ANDACurrent
62332-115Metoprolol Tartrate and HydrochlorothiazideMetoprolol Tartrate and HydrochlorothiazideAlembic Pharmaceuticals Inc.ANDACurrent
62332-115Metoprolol Tartrate and HydrochlorothiazideMetoprolol Tartrate and HydrochlorothiazideAlembic Pharmaceuticals Inc.ANDACurrent
62332-116Metoprolol Tartrate and HydrochlorothiazideMetoprolol Tartrate and HydrochlorothiazideAlembic Pharmaceuticals Inc.ANDACurrent
62332-116Metoprolol Tartrate and HydrochlorothiazideMetoprolol Tartrate and HydrochlorothiazideAlembic Pharmaceuticals Inc.ANDACurrent
62332-116Metoprolol Tartrate and HydrochlorothiazideMetoprolol Tartrate and HydrochlorothiazideAlembic Pharmaceuticals Inc.ANDACurrent
62332-116Metoprolol Tartrate and HydrochlorothiazideMetoprolol Tartrate and HydrochlorothiazideAlembic Pharmaceuticals Inc.ANDACurrent
62332-116Metoprolol Tartrate and HydrochlorothiazideMetoprolol Tartrate and HydrochlorothiazideAlembic Pharmaceuticals Inc.ANDACurrent
62332-117Metoprolol Tartrate and HydrochlorothiazideMetoprolol Tartrate and HydrochlorothiazideAlembic Pharmaceuticals Inc.ANDACurrent
62332-117Metoprolol Tartrate and HydrochlorothiazideMetoprolol Tartrate and HydrochlorothiazideAlembic Pharmaceuticals Inc.ANDACurrent
62332-117Metoprolol Tartrate and HydrochlorothiazideMetoprolol Tartrate and HydrochlorothiazideAlembic Pharmaceuticals Inc.ANDACurrent
62332-117Metoprolol Tartrate and HydrochlorothiazideMetoprolol Tartrate and HydrochlorothiazideAlembic Pharmaceuticals Inc.ANDACurrent
62332-117Metoprolol Tartrate and HydrochlorothiazideMetoprolol Tartrate and HydrochlorothiazideAlembic Pharmaceuticals Inc.ANDACurrent
63629-7331Metoprolol Tartrate and HydrochlorothiazideMetoprolol Tartrate and HydrochlorothiazideBryant Ranch PrepackANDACurrent
63629-7331Metoprolol Tartrate and HydrochlorothiazideMetoprolol Tartrate and HydrochlorothiazideBryant Ranch PrepackANDACurrent
63629-7331Metoprolol Tartrate and HydrochlorothiazideMetoprolol Tartrate and HydrochlorothiazideBryant Ranch PrepackANDACurrent
63629-7331Metoprolol Tartrate and HydrochlorothiazideMetoprolol Tartrate and HydrochlorothiazideBryant Ranch PrepackANDACurrent
63629-7332Metoprolol Tartrate and HydrochlorothiazideMetoprolol Tartrate and HydrochlorothiazideBryant Ranch PrepackANDACurrent
63629-7332Metoprolol Tartrate and HydrochlorothiazideMetoprolol Tartrate and HydrochlorothiazideBryant Ranch PrepackANDACurrent