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 1 of 12 · 222 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
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
PregabalinPREGABALINProficient Rx LP189b610e-3e29-42fa-ab6e-73effbe0d0542026-07-01Warnings, Adverse reactionsName fallback
brand name: Pregabalin
generic name: PREGABALIN
PregabalinPREGABALINSt. Mary's Medical Park Pharmacy35d3486c-c6ea-4d31-e063-6294a90a12192026-06-30Warnings, Adverse reactionsName fallback
brand name: Pregabalin
generic name: PREGABALIN
PregabalinPREGABALINSt. Mary's Medical Park Pharmacy35d387dd-bc7f-37a4-e063-6394a90abbbb2026-06-30Warnings, Adverse reactionsName fallback
brand name: Pregabalin
generic name: PREGABALIN
PregabalinPREGABALINSt. Mary's Medical Park Pharmacy36c3dda1-67fb-4dc5-e063-6294a90a1c3e2026-06-26Warnings, Adverse reactionsName fallback
brand name: Pregabalin
generic name: PREGABALIN
PregabalinPREGABALINSt. Mary's Medical Park Pharmacy2c62e63a-fe81-a463-e063-6394a90a65ee2026-06-26Warnings, Adverse reactionsName fallback
brand name: Pregabalin
generic name: PREGABALIN
PregabalinPREGABALINSt. Mary's Medical Park Pharmacy2e6e6f9c-a14c-2d75-e063-6294a90a827e2026-06-20Warnings, Adverse reactionsName fallback
brand name: Pregabalin
generic name: PREGABALIN
PregabalinPREGABALINREMEDYREPACK INC.ba3006b7-991f-4ae0-b908-5910e827e5bf2026-06-12Warnings, Adverse reactionsName fallback
brand name: Pregabalin
generic name: PREGABALIN
PregabalinPREGABALINREMEDYREPACK INC.d095accf-9cea-4948-b43d-ae1b8fbce7c22026-06-11Warnings, Adverse reactionsName fallback
brand name: Pregabalin
generic name: PREGABALIN
PregabalinPREGABALINClinical Solutions Wholesale, LLC150c8b71-98b0-4c6b-b20f-fd0fca2d3c262026-06-11Warnings, Adverse reactionsName fallback
brand name: Pregabalin
generic name: PREGABALIN
PREGABALINPREGABALINNovadoz Pharmaceuticals LLCf6aa5977-97c8-4a56-8e35-d9ab5cc243692026-06-10Warnings, Adverse reactionsName fallback
brand name: PREGABALIN
generic name: PREGABALIN
PregabalinPREGABALINCoupler LLC5383c0de-0c85-f702-e063-6294a90a1d8d2026-06-05Warnings, Adverse reactionsName fallback
brand name: Pregabalin
generic name: PREGABALIN
PregabalinPREGABALINST. MARY'S MEDICAL PARK PHARMACY923743f0-f557-9143-e053-2a95a90a21ae2026-06-05Warnings, 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