Application 209743

Type
ANDA
Sponsor
AMNEAL PHARMS CO

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 42.

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
A209743-001PREGABALINPREGABALIN25MGCAPSULE / ORALAB2019-07-19
A209743-002PREGABALINPREGABALIN50MGCAPSULE / ORALAB2019-07-19
A209743-003PREGABALINPREGABALIN75MGCAPSULE / ORALAB2019-07-19
A209743-004PREGABALINPREGABALIN100MGCAPSULE / ORALAB2019-07-19
A209743-005PREGABALINPREGABALIN150MGCAPSULE / ORALAB2019-07-19
A209743-006PREGABALINPREGABALIN200MGCAPSULE / ORALAB2019-07-19
A209743-007PREGABALINPREGABALIN225MGCAPSULE / ORALAB2019-07-19
A209743-008PREGABALINPREGABALIN300MGCAPSULE / ORALAB2019-07-19

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 8 matching rows.

Application-product, TE code table
Application-productTE code
A209743-001AB
A209743-002AB
A209743-003AB
A209743-004AB
A209743-005AB
A209743-006AB
A209743-007AB
A209743-008AB

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 9 · 328 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A209743-001PREGABALIN25MGCAPSULE / ORALAB2019-07-19caaa826d4ba7…
2026-08-18 06:07:402026-07A209743-002PREGABALIN50MGCAPSULE / ORALAB2019-07-19caaa826d4ba7…
2026-08-18 06:07:402026-07A209743-003PREGABALIN75MGCAPSULE / ORALAB2019-07-19caaa826d4ba7…
2026-08-18 06:07:402026-07A209743-004PREGABALIN100MGCAPSULE / ORALAB2019-07-19caaa826d4ba7…
2026-08-18 06:07:402026-07A209743-005PREGABALIN150MGCAPSULE / ORALAB2019-07-19caaa826d4ba7…
2026-08-18 06:07:402026-07A209743-006PREGABALIN200MGCAPSULE / ORALAB2019-07-19caaa826d4ba7…
2026-08-18 06:07:402026-07A209743-007PREGABALIN225MGCAPSULE / ORALAB2019-07-19caaa826d4ba7…
2026-08-18 06:07:402026-07A209743-008PREGABALIN300MGCAPSULE / ORALAB2019-07-19caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A209743-001PREGABALIN25MGCAPSULE / ORALAB2019-07-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209743-002PREGABALIN50MGCAPSULE / ORALAB2019-07-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209743-003PREGABALIN75MGCAPSULE / ORALAB2019-07-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209743-004PREGABALIN100MGCAPSULE / ORALAB2019-07-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209743-005PREGABALIN150MGCAPSULE / ORALAB2019-07-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209743-006PREGABALIN200MGCAPSULE / ORALAB2019-07-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209743-007PREGABALIN225MGCAPSULE / ORALAB2019-07-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209743-008PREGABALIN300MGCAPSULE / ORALAB2019-07-19011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209743-001PREGABALIN25MGCAPSULE / ORALAB2019-07-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209743-002PREGABALIN50MGCAPSULE / ORALAB2019-07-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209743-003PREGABALIN75MGCAPSULE / ORALAB2019-07-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209743-004PREGABALIN100MGCAPSULE / ORALAB2019-07-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209743-005PREGABALIN150MGCAPSULE / ORALAB2019-07-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209743-006PREGABALIN200MGCAPSULE / ORALAB2019-07-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209743-007PREGABALIN225MGCAPSULE / ORALAB2019-07-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209743-008PREGABALIN300MGCAPSULE / ORALAB2019-07-1931067a03dcf5…
2025-08-23 18:47 UTC2025-08A209743-001PREGABALIN25MGCAPSULE / ORALAB2019-07-196a471c1ec25d…
2025-08-23 18:47 UTC2025-08A209743-002PREGABALIN50MGCAPSULE / ORALAB2019-07-196a471c1ec25d…
2025-08-23 18:47 UTC2025-08A209743-003PREGABALIN75MGCAPSULE / ORALAB2019-07-196a471c1ec25d…
2025-08-23 18:47 UTC2025-08A209743-004PREGABALIN100MGCAPSULE / ORALAB2019-07-196a471c1ec25d…
2025-08-23 18:47 UTC2025-08A209743-005PREGABALIN150MGCAPSULE / ORALAB2019-07-196a471c1ec25d…
2025-08-23 18:47 UTC2025-08A209743-006PREGABALIN200MGCAPSULE / ORALAB2019-07-196a471c1ec25d…
2025-08-23 18:47 UTC2025-08A209743-007PREGABALIN225MGCAPSULE / ORALAB2019-07-196a471c1ec25d…
2025-08-23 18:47 UTC2025-08A209743-008PREGABALIN300MGCAPSULE / ORALAB2019-07-196a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209743-001PREGABALIN25MGCAPSULE / ORALAB2019-07-19fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209743-002PREGABALIN50MGCAPSULE / ORALAB2019-07-19fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209743-003PREGABALIN75MGCAPSULE / ORALAB2019-07-19fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209743-004PREGABALIN100MGCAPSULE / ORALAB2019-07-19fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209743-005PREGABALIN150MGCAPSULE / ORALAB2019-07-19fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209743-006PREGABALIN200MGCAPSULE / ORALAB2019-07-19fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209743-007PREGABALIN225MGCAPSULE / ORALAB2019-07-19fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209743-008PREGABALIN300MGCAPSULE / ORALAB2019-07-19fd3edfee7708…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 9 · 328 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A209743-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A209743-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A209743-003AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A209743-004AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A209743-005AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A209743-006AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A209743-007AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A209743-008AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A209743-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209743-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209743-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209743-004AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209743-005AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209743-006AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209743-007AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209743-008AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209743-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209743-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209743-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209743-004AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209743-005AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209743-006AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209743-007AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209743-008AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A209743-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A209743-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A209743-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A209743-004AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A209743-005AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A209743-006AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A209743-007AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A209743-008AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209743-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209743-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209743-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209743-004AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209743-005AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209743-006AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209743-007AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209743-008AB1fd3edfee7708…

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 · 10 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PregabalinPREGABALINREMEDYREPACK INC.d095accf-9cea-4948-b43d-ae1b8fbce7c22026-08-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209743
application number: ANDA209743
PregabalinPREGABALINAmneal Pharmaceuticals NY LLC3d9d7123-5886-4b61-a7ea-471b213e77d92026-04-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209743
application number: ANDA209743
ndc (product): 69238-1314
ndc (product): 69238-1312
ndc (product): 69238-1317
ndc (product): 69238-1316
ndc (product): 69238-1311
ndc (product): 69238-1310
ndc (product): 69238-1315
ndc (product): 69238-1313
PregabalinPREGABALINAmneal Pharmaceuticals NY LLC3099759f-cb24-40e8-b482-9388c38c73b92025-06-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209743
application number: ANDA209743
ndc (product): 60219-1313
ndc (product): 60219-1315
ndc (product): 60219-1317
ndc (product): 60219-1316
ndc (product): 60219-1311
ndc (product): 60219-1314
ndc (product): 60219-1310
ndc (product): 60219-1312
PREGABALINPREGABALINDirect_Rx91cf12b1-e1a6-dbc2-e053-2a95a90a8d5d2025-01-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209743
application number: ANDA209743
ndc (product): 72189-033
PregabalinPREGABALINAdvanced Rx of Tennessee, LLCafc89ca3-5597-1c75-e053-2a95a90a3ff22024-12-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209743
application number: ANDA209743
PregabalinPREGABALINAdvanced Rx of Tennessee, LLCaf739a0d-a3cd-754f-e053-2a95a90ad6552024-12-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209743
application number: ANDA209743
PregabalinPREGABALINAdvanced Rx Pharmacy of Tennessee, LLCb8172d6b-a646-e559-e053-2a95a90ac24d2024-12-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209743
application number: ANDA209743
PregabalinPREGABALINAdvanced Rx Pharmacy of Tennessee, LLCbc1b143d-feaf-9498-e053-2995a90acf502024-12-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209743
application number: ANDA209743
PregabalinPREGABALINAdvanced Rx Pharmacy of Tennessee, LLCb817083c-b535-2269-e053-2a95a90af5b92024-12-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209743
application number: ANDA209743
PregabalinPREGABALINProficient Rx LPa17f03ea-9375-48fe-be32-f8df509f5fba2023-06-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209743
application number: ANDA209743

NDC Listings For This Application#

NDC listings for this application page 1 of 2 · 122 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
60219-1310PregabalinPregabalinAmneal Pharmaceuticals NY LLCANDACurrent
60219-1310PregabalinPregabalinAmneal Pharmaceuticals NY LLCANDACurrent
60219-1311PregabalinPregabalinAmneal Pharmaceuticals NY LLCANDACurrent
60219-1311PregabalinPregabalinAmneal Pharmaceuticals NY LLCANDACurrent
60219-1312PregabalinPregabalinAmneal Pharmaceuticals NY LLCANDACurrent
60219-1312PregabalinPregabalinAmneal Pharmaceuticals NY LLCANDACurrent
60219-1313PregabalinPregabalinAmneal Pharmaceuticals NY LLCANDACurrent
60219-1313PregabalinPregabalinAmneal Pharmaceuticals NY LLCANDACurrent
60219-1314PregabalinPregabalinAmneal Pharmaceuticals NY LLCANDACurrent
60219-1314PregabalinPregabalinAmneal Pharmaceuticals NY LLCANDACurrent
60219-1315PregabalinPregabalinAmneal Pharmaceuticals NY LLCANDACurrent
60219-1315PregabalinPregabalinAmneal Pharmaceuticals NY LLCANDACurrent
60219-1316PregabalinPregabalinAmneal Pharmaceuticals NY LLCANDACurrent
60219-1316PregabalinPregabalinAmneal Pharmaceuticals NY LLCANDACurrent
60219-1317PregabalinPregabalinAmneal Pharmaceuticals NY LLCANDACurrent
60219-1317PregabalinPregabalinAmneal Pharmaceuticals NY LLCANDACurrent
69238-1310PregabalinPregabalinAmneal Pharmaceuticals NY LLCANDACurrent
69238-1310PregabalinPregabalinAmneal Pharmaceuticals NY LLCANDACurrent
69238-1310PregabalinPregabalinAmneal Pharmaceuticals NY LLCANDACurrent
69238-1311PregabalinPregabalinAmneal Pharmaceuticals NY LLCANDACurrent
69238-1311PregabalinPregabalinAmneal Pharmaceuticals NY LLCANDACurrent
69238-1311PregabalinPregabalinAmneal Pharmaceuticals NY LLCANDACurrent
69238-1312PregabalinPregabalinAmneal Pharmaceuticals NY LLCANDACurrent
69238-1312PregabalinPregabalinAmneal Pharmaceuticals NY LLCANDACurrent
69238-1312PregabalinPregabalinAmneal Pharmaceuticals NY LLCANDACurrent
69238-1313PregabalinPregabalinAmneal Pharmaceuticals NY LLCANDACurrent
69238-1313PregabalinPregabalinAmneal Pharmaceuticals NY LLCANDACurrent
69238-1313PregabalinPregabalinAmneal Pharmaceuticals NY LLCANDACurrent
69238-1314PregabalinPregabalinAmneal Pharmaceuticals NY LLCANDACurrent
69238-1314PregabalinPregabalinAmneal Pharmaceuticals NY LLCANDACurrent
69238-1314PregabalinPregabalinAmneal Pharmaceuticals NY LLCANDACurrent
69238-1315PregabalinPregabalinAmneal Pharmaceuticals NY LLCANDACurrent
69238-1315PregabalinPregabalinAmneal Pharmaceuticals NY LLCANDACurrent
69238-1315PregabalinPregabalinAmneal Pharmaceuticals NY LLCANDACurrent
69238-1316PregabalinPregabalinAmneal Pharmaceuticals NY LLCANDACurrent
69238-1316PregabalinPregabalinAmneal Pharmaceuticals NY LLCANDACurrent
69238-1316PregabalinPregabalinAmneal Pharmaceuticals NY LLCANDACurrent
69238-1317PregabalinPregabalinAmneal Pharmaceuticals NY LLCANDACurrent
69238-1317PregabalinPregabalinAmneal Pharmaceuticals NY LLCANDACurrent
69238-1317PregabalinPregabalinAmneal Pharmaceuticals NY LLCANDACurrent
70518-2364PregabalinPregabalinREMEDYREPACK INC.ANDACurrent
70518-2364PregabalinPregabalinREMEDYREPACK INC.ANDACurrent
70518-2364PregabalinPregabalinREMEDYREPACK INC.ANDACurrent
70518-2364PregabalinPregabalinREMEDYREPACK INC.ANDACurrent
70518-2364PregabalinPregabalinREMEDYREPACK INC.ANDACurrent
70518-2483PregabalinPregabalinREMEDYREPACK INC.ANDACurrent
70518-2483PregabalinPregabalinREMEDYREPACK INC.ANDACurrent
70518-2483PregabalinPregabalinREMEDYREPACK INC.ANDACurrent
70518-2483PregabalinPregabalinREMEDYREPACK INC.ANDACurrent
70518-2571PregabalinPregabalinREMEDYREPACK INC.ANDACurrent
70518-2571PregabalinPregabalinREMEDYREPACK INC.ANDACurrent
70518-2571PregabalinPregabalinREMEDYREPACK INC.ANDACurrent
70518-2571PregabalinPregabalinREMEDYREPACK INC.ANDACurrent
70518-2571PregabalinPregabalinREMEDYREPACK INC.ANDACurrent
70518-2948PregabalinPregabalinREMEDYREPACK INC.ANDACurrent
70518-2948PregabalinPregabalinREMEDYREPACK INC.ANDACurrent
70518-2948PregabalinPregabalinREMEDYREPACK INC.ANDACurrent
70518-2948PregabalinPregabalinREMEDYREPACK INC.ANDACurrent
70518-2978PregabalinPregabalinREMEDYREPACK INC.ANDACurrent
70518-2978PregabalinPregabalinREMEDYREPACK INC.ANDACurrent
70518-2980PregabalinPregabalinREMEDYREPACK INC.ANDACurrent
70518-2980PregabalinPregabalinREMEDYREPACK INC.ANDACurrent
72189-028PREGABALINPREGABALINDirect_RxANDACurrent
72189-028PREGABALINPREGABALINDirect_RxANDACurrent
72189-028PREGABALINPREGABALINDirect_RxANDACurrent
72189-032PREGABALINPREGABALINDirect_RxANDACurrent
72189-032PREGABALINPREGABALINDirect_RxANDACurrent
72189-032PREGABALINPREGABALINDirect_RxANDACurrent
72189-033PREGABALINPREGABALINDirect_RxANDACurrent
72189-033PREGABALINPREGABALINDirect_RxANDACurrent
72189-033PREGABALINPREGABALINDirect_RxANDACurrent
72189-033PREGABALINPREGABALINDirect_RxANDACurrent
72189-033PREGABALINPREGABALINDirect_RxANDACurrent
72189-033PREGABALINPREGABALINDirect_RxANDACurrent
72189-033PREGABALINPREGABALINDirect_RxANDACurrent
72189-033PREGABALINPREGABALINDirect_RxANDACurrent
72189-033PREGABALINPREGABALINDirect_RxANDACurrent
72189-033PREGABALINPREGABALINDirect_RxANDACurrent
72189-034PREGABALINPREGABALINDirect_RxANDACurrent
72189-034PREGABALINPREGABALINDirect_RxANDACurrent