Application 091025

Type
ANDA
Sponsor
ACTAVIS ELIZABETH

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001PREGABALINPREGABALINCAPSULE; ORAL25MGNoNo
002PREGABALINPREGABALINCAPSULE; ORAL50MGNoNo
003PREGABALINPREGABALINCAPSULE; ORAL75MGNoNo
004PREGABALINPREGABALINCAPSULE; ORAL100MGNoNo
005PREGABALINPREGABALINCAPSULE; ORAL150MGNoNo
006PREGABALINPREGABALINCAPSULE; ORAL200MGNoNo
007PREGABALINPREGABALINCAPSULE; ORAL225MGNoNo
008PREGABALINPREGABALINCAPSULE; ORAL300MGNoNo

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

Orange Book products#

Current product rows page 1 of 1 · 8 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A091025-001PREGABALINPREGABALIN25MGCAPSULE / ORAL2020-07-09
A091025-002PREGABALINPREGABALIN50MGCAPSULE / ORAL2020-07-09
A091025-003PREGABALINPREGABALIN75MGCAPSULE / ORAL2020-07-09
A091025-004PREGABALINPREGABALIN100MGCAPSULE / ORAL2020-07-09
A091025-005PREGABALINPREGABALIN150MGCAPSULE / ORAL2020-07-09
A091025-006PREGABALINPREGABALIN200MGCAPSULE / ORAL2020-07-09
A091025-007PREGABALINPREGABALIN225MGCAPSULE / ORAL2020-07-09
A091025-008PREGABALINPREGABALIN300MGCAPSULE / ORAL2020-07-09

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 8 · 296 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A091025-001PREGABALIN25MGCAPSULE / ORAL2020-07-09011fe1cb6892…
2026-02-19 14:30 UTC2026-02A091025-002PREGABALIN50MGCAPSULE / ORAL2020-07-09011fe1cb6892…
2026-02-19 14:30 UTC2026-02A091025-003PREGABALIN75MGCAPSULE / ORAL2020-07-09011fe1cb6892…
2026-02-19 14:30 UTC2026-02A091025-004PREGABALIN100MGCAPSULE / ORAL2020-07-09011fe1cb6892…
2026-02-19 14:30 UTC2026-02A091025-005PREGABALIN150MGCAPSULE / ORAL2020-07-09011fe1cb6892…
2026-02-19 14:30 UTC2026-02A091025-006PREGABALIN200MGCAPSULE / ORAL2020-07-09011fe1cb6892…
2026-02-19 14:30 UTC2026-02A091025-007PREGABALIN225MGCAPSULE / ORAL2020-07-09011fe1cb6892…
2026-02-19 14:30 UTC2026-02A091025-008PREGABALIN300MGCAPSULE / ORAL2020-07-09011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091025-001PREGABALIN25MGCAPSULE / ORAL2020-07-0931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091025-002PREGABALIN50MGCAPSULE / ORAL2020-07-0931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091025-003PREGABALIN75MGCAPSULE / ORAL2020-07-0931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091025-004PREGABALIN100MGCAPSULE / ORAL2020-07-0931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091025-005PREGABALIN150MGCAPSULE / ORAL2020-07-0931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091025-006PREGABALIN200MGCAPSULE / ORAL2020-07-0931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091025-007PREGABALIN225MGCAPSULE / ORAL2020-07-0931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091025-008PREGABALIN300MGCAPSULE / ORAL2020-07-0931067a03dcf5…
2025-08-23 18:47 UTC2025-08A091025-001PREGABALIN25MGCAPSULE / ORAL2020-07-096a471c1ec25d…
2025-08-23 18:47 UTC2025-08A091025-002PREGABALIN50MGCAPSULE / ORAL2020-07-096a471c1ec25d…
2025-08-23 18:47 UTC2025-08A091025-003PREGABALIN75MGCAPSULE / ORAL2020-07-096a471c1ec25d…
2025-08-23 18:47 UTC2025-08A091025-004PREGABALIN100MGCAPSULE / ORAL2020-07-096a471c1ec25d…
2025-08-23 18:47 UTC2025-08A091025-005PREGABALIN150MGCAPSULE / ORAL2020-07-096a471c1ec25d…
2025-08-23 18:47 UTC2025-08A091025-006PREGABALIN200MGCAPSULE / ORAL2020-07-096a471c1ec25d…
2025-08-23 18:47 UTC2025-08A091025-007PREGABALIN225MGCAPSULE / ORAL2020-07-096a471c1ec25d…
2025-08-23 18:47 UTC2025-08A091025-008PREGABALIN300MGCAPSULE / ORAL2020-07-096a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091025-001PREGABALIN25MGCAPSULE / ORALAB2020-07-09fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091025-002PREGABALIN50MGCAPSULE / ORALAB2020-07-09fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091025-003PREGABALIN75MGCAPSULE / ORALAB2020-07-09fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091025-004PREGABALIN100MGCAPSULE / ORALAB2020-07-09fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091025-005PREGABALIN150MGCAPSULE / ORALAB2020-07-09fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091025-006PREGABALIN200MGCAPSULE / ORALAB2020-07-09fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091025-007PREGABALIN225MGCAPSULE / ORALAB2020-07-09fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091025-008PREGABALIN300MGCAPSULE / ORALAB2020-07-09fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091025-001PREGABALIN25MGCAPSULE / ORALAB2020-07-09b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091025-002PREGABALIN50MGCAPSULE / ORALAB2020-07-09b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091025-003PREGABALIN75MGCAPSULE / ORALAB2020-07-09b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091025-004PREGABALIN100MGCAPSULE / ORALAB2020-07-09b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091025-005PREGABALIN150MGCAPSULE / ORALAB2020-07-09b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091025-006PREGABALIN200MGCAPSULE / ORALAB2020-07-09b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091025-007PREGABALIN225MGCAPSULE / ORALAB2020-07-09b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091025-008PREGABALIN300MGCAPSULE / ORALAB2020-07-09b8a1b40f171c…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 7 · 264 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091025-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091025-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091025-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091025-004AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091025-005AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091025-006AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091025-007AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091025-008AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091025-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091025-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091025-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091025-004AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091025-005AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091025-006AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091025-007AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091025-008AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091025-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091025-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091025-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091025-004AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091025-005AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091025-006AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091025-007AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091025-008AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091025-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091025-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091025-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091025-004AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091025-005AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091025-006AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091025-007AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091025-008AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091025-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091025-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091025-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091025-004AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091025-005AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091025-006AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091025-007AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091025-008AB15bbf6a4d5a75…

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 2 of 12 · 222 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PregabalinPREGABALINSt. Mary's Medical Park Pharmacy923745e9-17a2-a5f7-e053-2a95a90aed382026-06-04Warnings, Adverse reactionsName fallback
brand name: Pregabalin
generic name: PREGABALIN
PregabalinPREGABALINA-S Medication Solutionsb740832a-6e90-4b20-bfed-be0415f1aebe2026-06-03Warnings, Adverse reactionsName fallback
brand name: Pregabalin
generic name: PREGABALIN
PregabalinPREGABALINProficient Rx LPefc36145-fffd-44de-9a42-f277d0ff39c92026-06-01Warnings, Adverse reactionsName fallback
brand name: Pregabalin
generic name: PREGABALIN
PregabalinPREGABALINBryant Ranch Prepack45abbcb4-6a38-469d-9671-24b2c25e5b182026-05-15Warnings, Adverse reactionsName fallback
brand name: Pregabalin
generic name: PREGABALIN
PregabalinPREGABALINAphena Pharma Solutions - Tennessee, LLC4ddf9ede-5e8b-b5e1-e063-6394a90ac7f32026-05-05Warnings, Adverse reactionsName fallback
brand name: Pregabalin
generic name: PREGABALIN
PregabalinPREGABALINProficient Rx LP34846423-e747-42c5-9bcd-f99c557c4f672026-05-01Warnings, Adverse reactionsName fallback
brand name: Pregabalin
generic name: PREGABALIN
PregabalinPREGABALINAphena Pharma Solutions - Tennessee, LLC4d53c8e2-f03f-0f5b-e063-6294a90a23c62026-04-27Warnings, Adverse reactionsName fallback
brand name: Pregabalin
generic name: PREGABALIN
PregabalinPREGABALINAphena Pharma Solutions - Tennessee, LLC4ef59b1c-1273-5e54-e063-6294a90a0ec92026-04-21Warnings, Adverse reactionsName fallback
brand name: Pregabalin
generic name: PREGABALIN
PregabalinPREGABALINAurobindo Pharma Limited11034861-eef2-4996-8082-afc3c17691712026-04-15Warnings, Adverse reactionsName fallback
brand name: Pregabalin
generic name: PREGABALIN
PregabalinPREGABALINREMEDYREPACK INC.47d08b8f-a24d-4159-ab43-2eb67a93559b2026-04-14Warnings, Adverse reactionsName fallback
brand name: Pregabalin
generic name: PREGABALIN
PregabalinPREGABALINREMEDYREPACK INC.3c8ea6da-5771-4096-a915-700e51ced05c2026-04-14Warnings, Adverse reactionsName fallback
brand name: Pregabalin
generic name: PREGABALIN
PregabalinPREGABALINREMEDYREPACK INC.9c38abbc-2b3d-48d6-b629-4a163c803db52026-04-14Warnings, Adverse reactionsName fallback
brand name: Pregabalin
generic name: PREGABALIN
PregabalinPREGABALINREMEDYREPACK INC.efe06a26-30c5-437d-9fd1-4bd0062f12002026-04-14Warnings, Adverse reactionsName fallback
brand name: Pregabalin
generic name: PREGABALIN
PregabalinPREGABALINAmneal Pharmaceuticals NY LLC3d9d7123-5886-4b61-a7ea-471b213e77d92026-04-14Warnings, Adverse reactionsName fallback
brand name: Pregabalin
generic name: PREGABALIN
PregabalinPREGABALINREMEDYREPACK INC.12309847-0857-4ff7-a7e7-edeadc3dfb612026-04-13Warnings, Adverse reactionsName fallback
brand name: Pregabalin
generic name: PREGABALIN
PregabalinPREGABALINBryant Ranch Prepack1a8d8292-1f94-46da-bade-8c40542013432026-04-13Warnings, Adverse reactionsName fallback
brand name: Pregabalin
generic name: PREGABALIN
PregabalinPREGABALINBryant Ranch Prepackb977269a-7d62-44a2-bd0d-11c54b8728362026-04-10Warnings, Adverse reactionsName fallback
brand name: Pregabalin
generic name: PREGABALIN
PregabalinPREGABALINBryant Ranch Prepackfd01590e-5b90-4a77-ad5f-76adabf3c32e2026-04-09Warnings, Adverse reactionsName fallback
brand name: Pregabalin
generic name: PREGABALIN
PregabalinPREGABALINREMEDYREPACK INC.f30a7a3b-d45e-4e0b-ab1b-1369b2f023202026-04-08Warnings, Adverse reactionsName fallback
brand name: Pregabalin
generic name: PREGABALIN
PregabalinPREGABALINAphena Pharma Solutions - Tennessee, LLC4d63908b-96be-554c-e063-6394a90af5102026-04-08Warnings, Adverse reactionsName fallback
brand name: Pregabalin
generic name: PREGABALIN

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 28 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0228-2856PregabalinPregabalinActavis Pharma, Inc.ANDACurrent
0228-2856PregabalinPregabalinActavis Pharma, Inc.ANDACurrent
0228-2856PregabalinPregabalinActavis Pharma, Inc.ANDACurrent
0228-2856PregabalinPregabalinActavis Pharma, Inc.ANDACurrent
0228-2857PregabalinPregabalinActavis Pharma, Inc.ANDACurrent
0228-2857PregabalinPregabalinActavis Pharma, Inc.ANDACurrent
0228-2857PregabalinPregabalinActavis Pharma, Inc.ANDACurrent
0228-2857PregabalinPregabalinActavis Pharma, Inc.ANDACurrent
0228-2858PregabalinPregabalinActavis Pharma, Inc.ANDACurrent
0228-2858PregabalinPregabalinActavis Pharma, Inc.ANDACurrent
0228-2858PregabalinPregabalinActavis Pharma, Inc.ANDACurrent
0228-2858PregabalinPregabalinActavis Pharma, Inc.ANDACurrent
0228-2859PregabalinPregabalinActavis Pharma, Inc.ANDACurrent
0228-2859PregabalinPregabalinActavis Pharma, Inc.ANDACurrent
0228-2859PregabalinPregabalinActavis Pharma, Inc.ANDACurrent
0228-2859PregabalinPregabalinActavis Pharma, Inc.ANDACurrent
0228-2860PregabalinPregabalinActavis Pharma, Inc.ANDACurrent
0228-2860PregabalinPregabalinActavis Pharma, Inc.ANDACurrent
0228-2860PregabalinPregabalinActavis Pharma, Inc.ANDACurrent
0228-2861PregabalinPregabalinActavis Pharma, Inc.ANDACurrent
0228-2861PregabalinPregabalinActavis Pharma, Inc.ANDACurrent
0228-2861PregabalinPregabalinActavis Pharma, Inc.ANDACurrent
0228-2862PregabalinPregabalinActavis Pharma, Inc.ANDACurrent
0228-2862PregabalinPregabalinActavis Pharma, Inc.ANDACurrent
0228-2862PregabalinPregabalinActavis Pharma, Inc.ANDACurrent
0228-2863PregabalinPregabalinActavis Pharma, Inc.ANDACurrent
0228-2863PregabalinPregabalinActavis Pharma, Inc.ANDACurrent
0228-2863PregabalinPregabalinActavis Pharma, Inc.ANDACurrent