FDA.reportPublic FDA data

Application 217857

Type
ANDA
Sponsor
AIPING PHARM INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001PREGABALINPREGABALINTABLET, EXTENDED RELEASE;ORAL330MGNoNo

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

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
A217857-001PREGABALINPREGABALIN330MGTABLET, EXTENDED RELEASE / ORALAB2025-01-28
A217857-002PREGABALINPREGABALIN165MGTABLET, EXTENDED RELEASE / ORALAB2026-06-24

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A217857-001AB
A217857-002AB

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A217857-001PREGABALIN330MGTABLET, EXTENDED RELEASE / ORALAB2025-01-28caaa826d4ba7…
2026-08-18 06:07:402026-07A217857-002PREGABALIN165MGTABLET, EXTENDED RELEASE / ORALAB2026-06-24caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A217857-001PREGABALIN330MGTABLET, EXTENDED RELEASE / ORALAB2025-01-28011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A217857-001PREGABALIN330MGTABLET, EXTENDED RELEASE / ORALAB2025-01-2831067a03dcf5…
2025-08-23 18:47 UTC2025-08A217857-001PREGABALIN330MGTABLET, EXTENDED RELEASE / ORALAB2025-01-286a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A217857-001PREGABALIN330MGTABLET, EXTENDED RELEASE / ORALAB2025-01-28fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A217857-001PREGABALIN330MGTABLET, EXTENDED RELEASE / ORALAB2025-01-28b8a1b40f171c…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A217857-001PREGABALIN330MGTABLET, EXTENDED RELEASE / ORALAB2025-01-28a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A217857-002PREGABALIN165MGTABLET, EXTENDED RELEASE / ORALAB2026-06-24a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A217857-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A217857-002AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A217857-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A217857-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A217857-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A217857-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A217857-001AB1b8a1b40f171c…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A217857-001AB1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A217857-002AB1a50c72e98297…

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 12 · 226 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PregabalinPREGABALINREMEDYREPACK INC.12309847-0857-4ff7-a7e7-edeadc3dfb612026-08-14Warnings, Adverse reactionsName fallback
brand name: Pregabalin
generic name: PREGABALIN
PregabalinPREGABALINREMEDYREPACK INC.47d08b8f-a24d-4159-ab43-2eb67a93559b2026-08-14Warnings, Adverse reactionsName fallback
brand name: Pregabalin
generic name: PREGABALIN
PregabalinPREGABALINREMEDYREPACK INC.3c8ea6da-5771-4096-a915-700e51ced05c2026-08-14Warnings, Adverse reactionsName fallback
brand name: Pregabalin
generic name: PREGABALIN
PregabalinPREGABALINREMEDYREPACK INC.9c38abbc-2b3d-48d6-b629-4a163c803db52026-08-14Warnings, Adverse reactionsName fallback
brand name: Pregabalin
generic name: PREGABALIN
PregabalinPREGABALINREMEDYREPACK INC.efe06a26-30c5-437d-9fd1-4bd0062f12002026-08-14Warnings, Adverse reactionsName fallback
brand name: Pregabalin
generic name: PREGABALIN
PregabalinPREGABALINREMEDYREPACK INC.f30a7a3b-d45e-4e0b-ab1b-1369b2f023202026-08-06Warnings, Adverse reactionsName fallback
brand name: Pregabalin
generic name: PREGABALIN
PregabalinPREGABALINREMEDYREPACK INC.326c643a-23c5-4dab-9266-abc22ca1f8742026-08-06Warnings, Adverse reactionsName fallback
brand name: Pregabalin
generic name: PREGABALIN
PregabalinPREGABALINREMEDYREPACK INC.5d738807-7f88-4943-9c3b-01f1e52ea72d2026-08-05Warnings, Adverse reactionsName fallback
brand name: Pregabalin
generic name: PREGABALIN
PregabalinPREGABALINAscend Laboratories, LLCe48db3c2-7351-41f2-a451-5a8341c4125c2026-08-04Warnings, Adverse reactionsName fallback
brand name: Pregabalin
generic name: PREGABALIN
PregabalinPREGABALINREMEDYREPACK INC.9685792b-911d-4cf9-9881-d21abca48c662026-08-03Warnings, Adverse reactionsName fallback
brand name: Pregabalin
generic name: PREGABALIN
PregabalinPREGABALINREMEDYREPACK INC.c60752f8-20d5-4333-bf33-a656eab01d6b2026-08-03Warnings, Adverse reactionsName fallback
brand name: Pregabalin
generic name: PREGABALIN
PregabalinPREGABALINREMEDYREPACK INC.0f72ec70-314c-4c9f-86be-54f3e010356d2026-08-03Warnings, Adverse reactionsName fallback
brand name: Pregabalin
generic name: PREGABALIN
PregabalinPREGABALINREMEDYREPACK INC.91edbe87-cd22-43a5-9952-1cd523b138202026-07-29Warnings, Adverse reactionsName fallback
brand name: Pregabalin
generic name: PREGABALIN
PregabalinPREGABALINREMEDYREPACK INC.14f3f9ba-7a4a-45d5-a25e-efe5cdff117d2026-07-28Warnings, Adverse reactionsName fallback
brand name: Pregabalin
generic name: PREGABALIN
PregabalinPREGABALINREMEDYREPACK INC.44ec2918-4e0c-4e2d-9157-81295a15df572026-07-28Warnings, Adverse reactionsName fallback
brand name: Pregabalin
generic name: PREGABALIN
PregabalinPREGABALINBryant Ranch Prepack1e6fa742-f658-495f-88bb-8eddf9a45ffe2026-07-27Warnings, Adverse reactionsName fallback
brand name: Pregabalin
generic name: PREGABALIN
PregabalinPREGABALINBryant Ranch Prepack48798c13-3ef4-4e7f-9f73-92dccac0af142026-07-24Warnings, Adverse reactionsName fallback
brand name: Pregabalin
generic name: PREGABALIN
PREGABALINPREGABALINCardinal Health 107, LLC124176c7-d8ab-4bbe-b468-3e5d12f03e442026-07-21Warnings, Adverse reactionsName fallback
brand name: PREGABALIN
generic name: PREGABALIN
PregabalinPREGABALINSt. Mary's Medical Park Pharmacyfc5dd378-950f-949b-e053-6394a90a3ca22026-07-17Warnings, Adverse reactionsName fallback
brand name: Pregabalin
generic name: PREGABALIN
PregabalinPREGABALINSt. Mary's Medical Park Pharmacy9235cd08-7a25-4b81-e053-2995a90a539c2026-07-02Warnings, Adverse reactionsName fallback
brand name: Pregabalin
generic name: PREGABALIN