Application 077746

Type
ANDA
Sponsor
APOTEX

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001MIDODRINE HYDROCHLORIDEMIDODRINE HYDROCHLORIDETABLET;ORAL2.5MGNoNo
002MIDODRINE HYDROCHLORIDEMIDODRINE HYDROCHLORIDETABLET;ORAL5MGNoNo
003MIDODRINE HYDROCHLORIDEMIDODRINE HYDROCHLORIDETABLET;ORAL10MGNoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A077746-001MIDODRINE HYDROCHLORIDEMIDODRINE HYDROCHLORIDE2.5MGTABLET / ORALAB2006-09-12
A077746-002MIDODRINE HYDROCHLORIDEMIDODRINE HYDROCHLORIDE5MGTABLET / ORALAB2006-09-12
A077746-003MIDODRINE HYDROCHLORIDEMIDODRINE HYDROCHLORIDE10MGTABLET / ORALAB2006-09-12

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A077746-001AB
A077746-002AB
A077746-003AB

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 · 126 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A077746-001MIDODRINE HYDROCHLORIDE2.5MGTABLET / ORALAB2006-09-12caaa826d4ba7…
2026-08-18 06:07:402026-07A077746-002MIDODRINE HYDROCHLORIDE5MGTABLET / ORALAB2006-09-12caaa826d4ba7…
2026-08-18 06:07:402026-07A077746-003MIDODRINE HYDROCHLORIDE10MGTABLET / ORALAB2006-09-12caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A077746-001MIDODRINE HYDROCHLORIDE2.5MGTABLET / ORALAB2006-09-12011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077746-002MIDODRINE HYDROCHLORIDE5MGTABLET / ORALAB2006-09-12011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077746-003MIDODRINE HYDROCHLORIDE10MGTABLET / ORALAB2006-09-12011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077746-001MIDODRINE HYDROCHLORIDE2.5MGTABLET / ORALAB2006-09-1231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077746-002MIDODRINE HYDROCHLORIDE5MGTABLET / ORALAB2006-09-1231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077746-003MIDODRINE HYDROCHLORIDE10MGTABLET / ORALAB2006-09-1231067a03dcf5…
2025-08-23 18:47 UTC2025-08A077746-001MIDODRINE HYDROCHLORIDE2.5MGTABLET / ORALAB2006-09-126a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077746-002MIDODRINE HYDROCHLORIDE5MGTABLET / ORALAB2006-09-126a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077746-003MIDODRINE HYDROCHLORIDE10MGTABLET / ORALAB2006-09-126a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077746-001MIDODRINE HYDROCHLORIDE2.5MGTABLET / ORALAB2006-09-12fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077746-002MIDODRINE HYDROCHLORIDE5MGTABLET / ORALAB2006-09-12fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077746-003MIDODRINE HYDROCHLORIDE10MGTABLET / ORALAB2006-09-12fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077746-001MIDODRINE HYDROCHLORIDE2.5MGTABLET / ORALAB2006-09-12b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077746-002MIDODRINE HYDROCHLORIDE5MGTABLET / ORALAB2006-09-12b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077746-003MIDODRINE HYDROCHLORIDE10MGTABLET / ORALAB2006-09-12b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077746-001MIDODRINE HYDROCHLORIDE2.5MGTABLET / ORALAB2006-09-1203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077746-002MIDODRINE HYDROCHLORIDE5MGTABLET / ORALAB2006-09-1203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077746-003MIDODRINE HYDROCHLORIDE10MGTABLET / ORALAB2006-09-1203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077746-001MIDODRINE HYDROCHLORIDE2.5MGTABLET / ORALAB2006-09-122680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077746-002MIDODRINE HYDROCHLORIDE5MGTABLET / ORALAB2006-09-122680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077746-003MIDODRINE HYDROCHLORIDE10MGTABLET / ORALAB2006-09-122680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077746-001MIDODRINE HYDROCHLORIDE2.5MGTABLET / ORALAB2006-09-125bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077746-002MIDODRINE HYDROCHLORIDE5MGTABLET / ORALAB2006-09-125bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077746-003MIDODRINE HYDROCHLORIDE10MGTABLET / ORALAB2006-09-125bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077746-001MIDODRINE HYDROCHLORIDE2.5MGTABLET / ORALAB2006-09-12d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077746-002MIDODRINE HYDROCHLORIDE5MGTABLET / ORALAB2006-09-12d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077746-003MIDODRINE HYDROCHLORIDE10MGTABLET / ORALAB2006-09-12d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077746-001MIDODRINE HYDROCHLORIDE2.5MGTABLET / ORALAB2006-09-12d06236e962d9…
2024-10-29 15:01 UTC2024-10A077746-002MIDODRINE HYDROCHLORIDE5MGTABLET / ORALAB2006-09-12d06236e962d9…
2024-10-29 15:01 UTC2024-10A077746-003MIDODRINE HYDROCHLORIDE10MGTABLET / ORALAB2006-09-12d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077746-001MIDODRINE HYDROCHLORIDE2.5MGTABLET / ORALAB2006-09-1279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077746-002MIDODRINE HYDROCHLORIDE5MGTABLET / ORALAB2006-09-1279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077746-003MIDODRINE HYDROCHLORIDE10MGTABLET / ORALAB2006-09-1279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077746-001MIDODRINE HYDROCHLORIDE2.5MGTABLET / ORALAB2006-09-12301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077746-002MIDODRINE HYDROCHLORIDE5MGTABLET / ORALAB2006-09-12301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077746-003MIDODRINE HYDROCHLORIDE10MGTABLET / ORALAB2006-09-12301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077746-001MIDODRINE HYDROCHLORIDE2.5MGTABLET / ORALAB2006-09-121e350fbaab3a…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 126 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A077746-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A077746-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A077746-003AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A077746-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077746-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077746-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077746-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077746-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077746-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A077746-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077746-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077746-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077746-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077746-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077746-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077746-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077746-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077746-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077746-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077746-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077746-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077746-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077746-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077746-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077746-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077746-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077746-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077746-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077746-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077746-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077746-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A077746-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A077746-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077746-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077746-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077746-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077746-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077746-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077746-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077746-001AB11e350fbaab3a…

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 · 7 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Midodrine HydrochlorideMIDODRINE HYDROCHLORIDEAmerican Health Packaging159cb0cb-4b27-4a1c-8ad4-dc93604c79c72026-06-24Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077746
application number: ANDA077746
ndc (product): 60687-398
ndc (product): 60687-409
ndc (product): 60687-387
Midodrine HydrochlorideMIDODRINE HYDROCHLORIDEAvKARE1c2e8707-550f-430f-87f3-4bb3d55f4aba2026-01-14Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077746
application number: ANDA077746
ndc (product): 42291-561
ndc (product): 42291-562
ndc (product): 42291-560
Midodrine HydrochlorideMIDODRINE HYDROCHLORIDECardinal Health 107, LLC5e2443c2-f714-4b1d-bf2d-22742f4119612025-11-06Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077746
application number: ANDA077746
ndc (product): 55154-8086
Midodrine HydrochlorideMIDODRINE HYDROCHLORIDEMajor Pharmaceuticals164dce3b-1927-497e-884a-a2c72958beb92025-07-15Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077746
application number: ANDA077746
ndc (product): 0904-6818
ndc (product): 0904-6817
ndc (product): 0904-6819
Midodrine HydrochlorideMIDODRINE HYDROCHLORIDEApotex Corpaec0d2de-ce83-b7c2-5d10-740607d505212025-07-10Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077746
application number: ANDA077746
ndc (product): 60505-1325
ndc (product): 60505-1320
ndc (product): 60505-1321
Midodrine HydrochlorideMIDODRINE HYDROCHLORIDEAvPAK9106776e-601a-4e3c-e053-2995a90a54352025-04-17Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077746
application number: ANDA077746
ndc (product): 50268-562
ndc (product): 50268-563
ndc (product): 50268-561
Midodrine HydrochlorideMIDODRINE HYDROCHLORIDEBryant Ranch Prepackc41f7ec2-a3d7-4ff0-b51d-feda49717e7b2024-10-07Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077746
application number: ANDA077746
ndc (product): 71335-1433

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 49 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0615-8291Midodrine HydrochlorideMidodrine HydrochlorideNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-8291Midodrine HydrochlorideMidodrine HydrochlorideNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-8291Midodrine HydrochlorideMidodrine HydrochlorideNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-8293Midodrine HydrochlorideMidodrine HydrochlorideNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-8293Midodrine HydrochlorideMidodrine HydrochlorideNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-8293Midodrine HydrochlorideMidodrine HydrochlorideNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-8358midodrine hydrochloridemidodrineNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-8358midodrine hydrochloridemidodrineNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0904-6817Midodrine HydrochlorideMidodrine HydrochlorideMajor PharmaceuticalsANDACurrent
0904-6817Midodrine HydrochlorideMidodrine HydrochlorideMajor PharmaceuticalsANDACurrent
0904-6817Midodrine HydrochlorideMidodrine HydrochlorideMajor PharmaceuticalsANDACurrent
0904-6817Midodrine HydrochlorideMidodrine HydrochlorideMajor PharmaceuticalsANDACurrent
0904-6817Midodrine HydrochlorideMidodrine HydrochlorideMajor PharmaceuticalsANDACurrent
0904-6818Midodrine HydrochlorideMidodrine HydrochlorideMajor PharmaceuticalsANDACurrent
0904-6818Midodrine HydrochlorideMidodrine HydrochlorideMajor PharmaceuticalsANDACurrent
0904-6818Midodrine HydrochlorideMidodrine HydrochlorideMajor PharmaceuticalsANDACurrent
0904-6818Midodrine HydrochlorideMidodrine HydrochlorideMajor PharmaceuticalsANDACurrent
0904-6818Midodrine HydrochlorideMidodrine HydrochlorideMajor PharmaceuticalsANDACurrent
0904-6819Midodrine HydrochlorideMidodrine HydrochlorideMajor PharmaceuticalsANDACurrent
0904-6819Midodrine HydrochlorideMidodrine HydrochlorideMajor PharmaceuticalsANDACurrent
0904-6819Midodrine HydrochlorideMidodrine HydrochlorideMajor PharmaceuticalsANDACurrent
0904-6819Midodrine HydrochlorideMidodrine HydrochlorideMajor PharmaceuticalsANDACurrent
42291-560Midodrine HydrochlorideMidodrine HydrochlorideAvKARE, Inc.ANDACurrent
42291-560Midodrine HydrochlorideMidodrine HydrochlorideAvKAREANDACurrent
42291-561Midodrine HydrochlorideMidodrine HydrochlorideAvKARE, Inc.ANDACurrent
42291-561Midodrine HydrochlorideMidodrine HydrochlorideAvKAREANDACurrent
42291-562Midodrine HydrochlorideMidodrine HydrochlorideAvKARE, Inc.ANDACurrent
42291-562Midodrine HydrochlorideMidodrine HydrochlorideAvKAREANDACurrent
50268-561Midodrine HydrochlorideMidodrine HydrochlorideAvPAKANDACurrent
50268-561Midodrine HydrochlorideMidodrine HydrochlorideAvPAKANDACurrent
50268-562Midodrine HydrochlorideMidodrine HydrochlorideAvPAKANDACurrent
50268-562Midodrine HydrochlorideMidodrine HydrochlorideAvPAKANDACurrent
50268-563Midodrine HydrochlorideMidodrine HydrochlorideAvPAKANDACurrent
50268-563Midodrine HydrochlorideMidodrine HydrochlorideAvPAKANDACurrent
55154-8086Midodrine HydrochlorideMidodrine HydrochlorideCardinal HealthANDACurrent
55154-8086Midodrine HydrochlorideMidodrine HydrochlorideCardinal Health 107, LLCANDACurrent
60505-1320Midodrine HydrochlorideMidodrine HydrochlorideApotex CorpANDACurrent
60505-1321Midodrine HydrochlorideMidodrine HydrochlorideApotex CorpANDACurrent
60505-1325Midodrine HydrochlorideMidodrine HydrochlorideApotex CorpANDACurrent
60687-387Midodrine HydrochlorideMidodrine HydrochlorideAmerican Health PackagingANDACurrent
60687-387Midodrine HydrochlorideMidodrine HydrochlorideAmerican Health PackagingANDACurrent
60687-387Midodrine HydrochlorideMidodrine HydrochlorideAmerican Health PackagingANDACurrent
60687-398Midodrine HydrochlorideMidodrine HydrochlorideAmerican Health PackagingANDACurrent
60687-398Midodrine HydrochlorideMidodrine HydrochlorideAmerican Health PackagingANDACurrent
60687-398Midodrine HydrochlorideMidodrine HydrochlorideAmerican Health PackagingANDACurrent
60687-409Midodrine HydrochlorideMidodrine HydrochlorideAmerican Health PackagingANDACurrent
60687-409Midodrine HydrochlorideMidodrine HydrochlorideAmerican Health PackagingANDACurrent
60687-409Midodrine HydrochlorideMidodrine HydrochlorideAmerican Health PackagingANDACurrent
71335-1433Midodrine HydrochlorideMidodrine HydrochlorideBryant Ranch PrepackANDACurrent