Application 201507

Type
ANDA
Sponsor
HERITAGE PHARMA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001HYDROXYZINE PAMOATEHYDROXYZINE PAMOATECAPSULE;ORALEQ 25MG HYDROCHLORIDENoNo
002HYDROXYZINE PAMOATEHYDROXYZINE PAMOATECAPSULE;ORALEQ 50MG HYDROCHLORIDENoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A201507-001HYDROXYZINE PAMOATEHYDROXYZINE PAMOATEEQ 25MG HYDROCHLORIDECAPSULE / ORALAB2013-06-03
A201507-002HYDROXYZINE PAMOATEHYDROXYZINE PAMOATEEQ 50MG HYDROCHLORIDECAPSULE / ORALABRS2013-06-03

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A201507-001AB
A201507-002AB

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 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A201507-001HYDROXYZINE PAMOATEEQ 25MG HYDROCHLORIDECAPSULE / ORALAB2013-06-03011fe1cb6892…
2026-02-19 14:30 UTC2026-02A201507-002HYDROXYZINE PAMOATEEQ 50MG HYDROCHLORIDECAPSULE / ORALABRS2013-06-03011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A201507-001HYDROXYZINE PAMOATEEQ 25MG HYDROCHLORIDECAPSULE / ORALAB2013-06-0331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A201507-002HYDROXYZINE PAMOATEEQ 50MG HYDROCHLORIDECAPSULE / ORALABRS2013-06-0331067a03dcf5…
2025-08-23 18:47 UTC2025-08A201507-001HYDROXYZINE PAMOATEEQ 25MG HYDROCHLORIDECAPSULE / ORALAB2013-06-036a471c1ec25d…
2025-08-23 18:47 UTC2025-08A201507-002HYDROXYZINE PAMOATEEQ 50MG HYDROCHLORIDECAPSULE / ORALABRS2013-06-036a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A201507-001HYDROXYZINE PAMOATEEQ 25MG HYDROCHLORIDECAPSULE / ORALAB2013-06-03fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A201507-002HYDROXYZINE PAMOATEEQ 50MG HYDROCHLORIDECAPSULE / ORALABRS2013-06-03fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A201507-001HYDROXYZINE PAMOATEEQ 25MG HYDROCHLORIDECAPSULE / ORALAB2013-06-03b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A201507-002HYDROXYZINE PAMOATEEQ 50MG HYDROCHLORIDECAPSULE / ORALABRS2013-06-03b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A201507-001HYDROXYZINE PAMOATEEQ 25MG HYDROCHLORIDECAPSULE / ORALAB2013-06-0303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A201507-002HYDROXYZINE PAMOATEEQ 50MG HYDROCHLORIDECAPSULE / ORALABRS2013-06-0303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A201507-001HYDROXYZINE PAMOATEEQ 25MG HYDROCHLORIDECAPSULE / ORALAB2013-06-032680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A201507-002HYDROXYZINE PAMOATEEQ 50MG HYDROCHLORIDECAPSULE / ORALABRS2013-06-032680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A201507-001HYDROXYZINE PAMOATEEQ 25MG HYDROCHLORIDECAPSULE / ORALAB2013-06-035bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A201507-002HYDROXYZINE PAMOATEEQ 50MG HYDROCHLORIDECAPSULE / ORALABRS2013-06-035bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A201507-001HYDROXYZINE PAMOATEEQ 25MG HYDROCHLORIDECAPSULE / ORALAB2013-06-03d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A201507-002HYDROXYZINE PAMOATEEQ 50MG HYDROCHLORIDECAPSULE / ORALABRS2013-06-03d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A201507-001HYDROXYZINE PAMOATEEQ 25MG HYDROCHLORIDECAPSULE / ORALAB2013-06-03d06236e962d9…
2024-10-29 15:01 UTC2024-10A201507-002HYDROXYZINE PAMOATEEQ 50MG HYDROCHLORIDECAPSULE / ORALABRS2013-06-03d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A201507-001HYDROXYZINE PAMOATEEQ 25MG HYDROCHLORIDECAPSULE / ORALAB2013-06-0379d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A201507-002HYDROXYZINE PAMOATEEQ 50MG HYDROCHLORIDECAPSULE / ORALABRS2013-06-0379d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A201507-001HYDROXYZINE PAMOATEEQ 25MG HYDROCHLORIDECAPSULE / ORALAB2013-06-03301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A201507-002HYDROXYZINE PAMOATEEQ 50MG HYDROCHLORIDECAPSULE / ORALAB2013-06-03301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A201507-001HYDROXYZINE PAMOATEEQ 25MG HYDROCHLORIDECAPSULE / ORALAB2013-06-031e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A201507-002HYDROXYZINE PAMOATEEQ 50MG HYDROCHLORIDECAPSULE / ORALAB2013-06-031e350fbaab3a…
2024-05-31 18:47 UTC2024-05A201507-001HYDROXYZINE PAMOATEEQ 25MG HYDROCHLORIDECAPSULE / ORALAB2013-06-038072bd15b7f6…
2024-05-31 18:47 UTC2024-05A201507-002HYDROXYZINE PAMOATEEQ 50MG HYDROCHLORIDECAPSULE / ORALAB2013-06-038072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A201507-001HYDROXYZINE PAMOATEEQ 25MG HYDROCHLORIDECAPSULE / ORALBX2013-06-035c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A201507-002HYDROXYZINE PAMOATEEQ 50MG HYDROCHLORIDECAPSULE / ORALBX2013-06-035c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A201507-001HYDROXYZINE PAMOATEEQ 25MG HYDROCHLORIDECAPSULE / ORALBX2013-06-035d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A201507-002HYDROXYZINE PAMOATEEQ 50MG HYDROCHLORIDECAPSULE / ORALBX2013-06-035d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A201507-001HYDROXYZINE PAMOATEEQ 25MG HYDROCHLORIDECAPSULE / ORALBX2013-06-034b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A201507-002HYDROXYZINE PAMOATEEQ 50MG HYDROCHLORIDECAPSULE / ORALBX2013-06-034b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A201507-001HYDROXYZINE PAMOATEEQ 25MG HYDROCHLORIDECAPSULE / ORALAB2013-06-0374a2ff9319b5…
2019-12-13 00:20 UTC2019-12A201507-002HYDROXYZINE PAMOATEEQ 50MG HYDROCHLORIDECAPSULE / ORALAB2013-06-0374a2ff9319b5…
2022-03-09 01:35 UTC2022-03A201507-001HYDROXYZINE PAMOATEEQ 25MG HYDROCHLORIDECAPSULE / ORALBX2013-06-03bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A201507-002HYDROXYZINE PAMOATEEQ 50MG HYDROCHLORIDECAPSULE / ORALBX2013-06-03bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A201507-001HYDROXYZINE PAMOATEEQ 25MG HYDROCHLORIDECAPSULE / ORALBX2013-06-03782e0a99824c…
2021-12-28 21:50 UTC2021-12A201507-002HYDROXYZINE PAMOATEEQ 50MG HYDROCHLORIDECAPSULE / ORALBX2013-06-03782e0a99824c…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A201507-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A201507-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A201507-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A201507-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A201507-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A201507-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A201507-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A201507-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A201507-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A201507-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A201507-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A201507-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A201507-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A201507-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A201507-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A201507-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A201507-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A201507-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A201507-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A201507-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A201507-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A201507-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A201507-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A201507-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A201507-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A201507-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A201507-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A201507-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A201507-001BX15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A201507-002BX15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A201507-001BX15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A201507-002BX15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A201507-001BX14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A201507-002BX14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A201507-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A201507-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A201507-001BX1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A201507-002BX1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A201507-001BX1782e0a99824c…
2021-12-28 21:50 UTC2021-12A201507-002BX1782e0a99824c…

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 2 · 21 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
hydroxyzine pamoateHYDROXYZINE PAMOATECardinal Health 107, LLC6ffb7c82-f780-4527-a7c3-e7d0f7b3b91e2026-05-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201507
application number: ANDA201507
hydroxyzine pamoateHYDROXYZINE PAMOATECoupler LLC5020c699-6fc5-b166-e063-6294a90a58812026-04-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201507
application number: ANDA201507
hydroxyzine pamoateHYDROXYZINE PAMOATEPreferred Pharmaceuticals Inc.b903f7e1-250d-46d8-a1ec-3f1dabc597f12026-01-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201507
application number: ANDA201507
hydroxyzine pamoateHYDROXYZINE PAMOATENorthwind Health Company, LLC127617c2-9775-3859-e063-6394a90a77cd2026-01-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201507
application number: ANDA201507
hydroxyzine pamoateHYDROXYZINE PAMOATENorthwind Health Company, LLCdb8987d6-9814-50f6-e053-2a95a90a82a92026-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201507
application number: ANDA201507
Hydroxyzine pamoateHYDROXYZINE PAMOATEChartwell RX, LLCabe7280a-1f6a-404b-9874-7710121e20902025-12-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201507
application number: ANDA201507
hydroxyzine pamoateHYDROXYZINE PAMOATEMajor Pharmaceuticalsf28f2a1b-8d65-4646-bd99-6e77617f9e1f2025-12-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201507
application number: ANDA201507
hydroxyzine pamoateHYDROXYZINE PAMOATEBryant Ranch Prepack7996dfa3-7f34-4d20-acaa-7f6fc021fc802025-09-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201507
application number: ANDA201507
ndc (product): 71335-1325
hydroxyzine pamoateHYDROXYZINE PAMOATEREMEDYREPACK INC.c0f7f48d-e39c-4981-9c0e-5c2eccaba4242025-09-11Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201507
application number: ANDA201507
hydroxyzine pamoateHYDROXYZINE PAMOATEGolden State Medical Supply, Inc.240fd428-15af-e7d0-e063-6394a90acbc52025-08-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201507
application number: ANDA201507
hydroxyzine pamoateHYDROXYZINE PAMOATEHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.734d32c8-38d3-430f-a2b3-539e03a3687a2025-07-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201507
application number: ANDA201507
hydroxyzine pamoateHYDROXYZINE PAMOATEPreferred Pharmaceuticals, Inc.2a66117a-fcd4-4094-927c-3a7699ef96602025-06-27Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201507
application number: ANDA201507
hydroxyzine pamoateHYDROXYZINE PAMOATEA-S Medication Solutions74bf62c3-b444-46dc-aab6-af74b101a68a2025-04-28Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201507
application number: ANDA201507
hydroxyzine pamoateHYDROXYZINE PAMOATEAphena Pharma Solutions - Tennessee, LLC308cd178-a9d2-3132-e063-6394a90a73572025-04-28Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201507
application number: ANDA201507
Hydroxyzine PamoateHYDROXYZINE PAMOATEDirect_Rx8c395a13-9da3-7b77-e053-2995a90a19162025-01-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201507
application number: ANDA201507
ndc (product): 72189-009
hydroxyzine pamoateHYDROXYZINE PAMOATEA-S Medication Solutionsa31271f0-ac60-4fda-b1f5-ddf7241c8a0e2024-10-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201507
application number: ANDA201507
hydroxyzine pamoateHYDROXYZINE PAMOATENuCare Pharmaceuticals,Inc.8cb94f1d-1e45-531a-e053-2a95a90a1ba02024-06-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201507
application number: ANDA201507
hydroxyzine pamoateHYDROXYZINE PAMOATEBryant Ranch Prepackdde576e9-fb6b-40d2-a81f-ebb8656c4c9c2024-05-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201507
application number: ANDA201507
ndc (product): 71335-1265
hydroxyzine pamoateHYDROXYZINE PAMOATENuCare Pharmaceuticals,Inc.1302c511-eb25-5818-e063-6394a90a92252024-03-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201507
application number: ANDA201507
hydroxyzine pamoateHYDROXYZINE PAMOATEAphena Pharma Solutions - Tennessee, LLC78005ad7-290c-4716-937f-f0ec82f4e6072024-02-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201507
application number: ANDA201507

NDC Listings For This Application#

NDC listings for this application page 2 of 2 · 96 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
71205-433hydroxyzine pamoatehydroxyzine pamoateProficient Rx LPANDACurrent
71335-0224HYDROXYZINE PAMOATEHYDROXYZINE PAMOATEBryant Ranch PrepackANDACurrent
71335-0438HYDROXYZINE PAMOATEHYDROXYZINE PAMOATEBryant Ranch PrepackANDACurrent
71335-1265hydroxyzine pamoatehydroxyzine pamoateBryant Ranch PrepackANDACurrent
71335-1265hydroxyzine pamoatehydroxyzine pamoateBryant Ranch PrepackANDACurrent
71335-1265hydroxyzine pamoatehydroxyzine pamoateBryant Ranch PrepackANDACurrent
71335-1265hydroxyzine pamoatehydroxyzine pamoateBryant Ranch PrepackANDACurrent
71335-1325hydroxyzine pamoatehydroxyzine pamoateBryant Ranch PrepackANDACurrent
71335-1325hydroxyzine pamoatehydroxyzine pamoateBryant Ranch PrepackANDACurrent
71335-1325hydroxyzine pamoatehydroxyzine pamoateBryant Ranch PrepackANDACurrent
71335-1325hydroxyzine pamoatehydroxyzine pamoateBryant Ranch PrepackANDACurrent
71610-397hydroxyzine pamoatehydroxyzine pamoateAphena Pharma Solutions - Tennessee, LLCANDACurrent
71610-397hydroxyzine pamoatehydroxyzine pamoateAphena Pharma Solutions - Tennessee, LLCANDACurrent
72189-009Hydroxyzine PamoateHydroxyzine PamoateDirect_RxANDACurrent
72189-009Hydroxyzine PamoateHydroxyzine PamoateDirect_RxANDACurrent
72189-009Hydroxyzine PamoateHydroxyzine PamoateDirect_RxANDACurrent