Application 206912

Type
ANDA
Sponsor
HETERO LABS LTD III

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
A206912-001PREGABALINPREGABALIN25MGCAPSULE / ORALAB2019-10-08
A206912-002PREGABALINPREGABALIN50MGCAPSULE / ORALAB2019-10-08
A206912-003PREGABALINPREGABALIN75MGCAPSULE / ORALAB2019-10-08
A206912-004PREGABALINPREGABALIN100MGCAPSULE / ORALAB2019-10-08
A206912-005PREGABALINPREGABALIN150MGCAPSULE / ORALAB2019-10-08
A206912-006PREGABALINPREGABALIN200MGCAPSULE / ORALAB2019-10-08
A206912-007PREGABALINPREGABALIN225MGCAPSULE / ORALAB2019-10-08
A206912-008PREGABALINPREGABALIN300MGCAPSULE / ORALAB2019-10-08

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A206912-001AB
A206912-002AB
A206912-003AB
A206912-004AB
A206912-005AB
A206912-006AB
A206912-007AB
A206912-008AB

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 8 · 312 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A206912-001PREGABALIN25MGCAPSULE / ORALAB2019-10-08011fe1cb6892…
2026-02-19 14:30 UTC2026-02A206912-002PREGABALIN50MGCAPSULE / ORALAB2019-10-08011fe1cb6892…
2026-02-19 14:30 UTC2026-02A206912-003PREGABALIN75MGCAPSULE / ORALAB2019-10-08011fe1cb6892…
2026-02-19 14:30 UTC2026-02A206912-004PREGABALIN100MGCAPSULE / ORALAB2019-10-08011fe1cb6892…
2026-02-19 14:30 UTC2026-02A206912-005PREGABALIN150MGCAPSULE / ORALAB2019-10-08011fe1cb6892…
2026-02-19 14:30 UTC2026-02A206912-006PREGABALIN200MGCAPSULE / ORALAB2019-10-08011fe1cb6892…
2026-02-19 14:30 UTC2026-02A206912-007PREGABALIN225MGCAPSULE / ORALAB2019-10-08011fe1cb6892…
2026-02-19 14:30 UTC2026-02A206912-008PREGABALIN300MGCAPSULE / ORALAB2019-10-08011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206912-001PREGABALIN25MGCAPSULE / ORALAB2019-10-0831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206912-002PREGABALIN50MGCAPSULE / ORALAB2019-10-0831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206912-003PREGABALIN75MGCAPSULE / ORALAB2019-10-0831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206912-004PREGABALIN100MGCAPSULE / ORALAB2019-10-0831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206912-005PREGABALIN150MGCAPSULE / ORALAB2019-10-0831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206912-006PREGABALIN200MGCAPSULE / ORALAB2019-10-0831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206912-007PREGABALIN225MGCAPSULE / ORALAB2019-10-0831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206912-008PREGABALIN300MGCAPSULE / ORALAB2019-10-0831067a03dcf5…
2025-08-23 18:47 UTC2025-08A206912-001PREGABALIN25MGCAPSULE / ORALAB2019-10-086a471c1ec25d…
2025-08-23 18:47 UTC2025-08A206912-002PREGABALIN50MGCAPSULE / ORALAB2019-10-086a471c1ec25d…
2025-08-23 18:47 UTC2025-08A206912-003PREGABALIN75MGCAPSULE / ORALAB2019-10-086a471c1ec25d…
2025-08-23 18:47 UTC2025-08A206912-004PREGABALIN100MGCAPSULE / ORALAB2019-10-086a471c1ec25d…
2025-08-23 18:47 UTC2025-08A206912-005PREGABALIN150MGCAPSULE / ORALAB2019-10-086a471c1ec25d…
2025-08-23 18:47 UTC2025-08A206912-006PREGABALIN200MGCAPSULE / ORALAB2019-10-086a471c1ec25d…
2025-08-23 18:47 UTC2025-08A206912-007PREGABALIN225MGCAPSULE / ORALAB2019-10-086a471c1ec25d…
2025-08-23 18:47 UTC2025-08A206912-008PREGABALIN300MGCAPSULE / ORALAB2019-10-086a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206912-001PREGABALIN25MGCAPSULE / ORALAB2019-10-08fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206912-002PREGABALIN50MGCAPSULE / ORALAB2019-10-08fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206912-003PREGABALIN75MGCAPSULE / ORALAB2019-10-08fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206912-004PREGABALIN100MGCAPSULE / ORALAB2019-10-08fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206912-005PREGABALIN150MGCAPSULE / ORALAB2019-10-08fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206912-006PREGABALIN200MGCAPSULE / ORALAB2019-10-08fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206912-007PREGABALIN225MGCAPSULE / ORALAB2019-10-08fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206912-008PREGABALIN300MGCAPSULE / ORALAB2019-10-08fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206912-001PREGABALIN25MGCAPSULE / ORALAB2019-10-08b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206912-002PREGABALIN50MGCAPSULE / ORALAB2019-10-08b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206912-003PREGABALIN75MGCAPSULE / ORALAB2019-10-08b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206912-004PREGABALIN100MGCAPSULE / ORALAB2019-10-08b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206912-005PREGABALIN150MGCAPSULE / ORALAB2019-10-08b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206912-006PREGABALIN200MGCAPSULE / ORALAB2019-10-08b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206912-007PREGABALIN225MGCAPSULE / ORALAB2019-10-08b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206912-008PREGABALIN300MGCAPSULE / ORALAB2019-10-08b8a1b40f171c…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 8 · 312 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A206912-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A206912-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A206912-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A206912-004AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A206912-005AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A206912-006AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A206912-007AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A206912-008AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206912-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206912-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206912-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206912-004AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206912-005AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206912-006AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206912-007AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206912-008AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A206912-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A206912-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A206912-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A206912-004AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A206912-005AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A206912-006AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A206912-007AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A206912-008AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206912-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206912-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206912-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206912-004AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206912-005AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206912-006AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206912-007AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206912-008AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206912-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206912-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206912-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206912-004AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206912-005AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206912-006AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206912-007AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206912-008AB1b8a1b40f171c…

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 · 22 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PregabalinPREGABALINBryant Ranch Prepack1e6fa742-f658-495f-88bb-8eddf9a45ffe2026-07-27Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206912
application number: ANDA206912
PregabalinPREGABALINBryant Ranch Prepack48798c13-3ef4-4e7f-9f73-92dccac0af142026-07-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206912
application number: ANDA206912
ndc (product): 71335-1790
PregabalinPREGABALINSt. Mary's Medical Park Pharmacy2c62e63a-fe81-a463-e063-6394a90a65ee2026-06-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206912
application number: ANDA206912
PregabalinPREGABALINA-S Medication Solutionsb740832a-6e90-4b20-bfed-be0415f1aebe2026-06-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206912
application number: ANDA206912
PregabalinPREGABALINProficient Rx LPefc36145-fffd-44de-9a42-f277d0ff39c92026-06-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206912
application number: ANDA206912
PregabalinPREGABALINREMEDYREPACK INC.c60752f8-20d5-4333-bf33-a656eab01d6b2026-03-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206912
application number: ANDA206912
PregabalinPREGABALINNorthStar RxLLC4a4d4c76-31c5-413b-be7c-82cb8091c19d2025-12-12Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206912
application number: ANDA206912
PregabalinPREGABALINREMEDYREPACK INC.e897d7e8-2743-4512-8417-375cb11ceec62025-10-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206912
application number: ANDA206912
PregabalinPREGABALINCamber Pharmaceuticals, Inc.241c4b7e-f719-4828-8639-ea613b8a65832025-09-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206912
application number: ANDA206912
ndc (product): 31722-613
ndc (product): 31722-614
ndc (product): 31722-617
ndc (product): 31722-615
ndc (product): 31722-616
ndc (product): 31722-611
ndc (product): 31722-610
ndc (product): 31722-612
PregabalinPREGABALINPreferred Pharmaceuticals Inc.dc50f01d-1802-4666-8f2f-35980a40990f2025-09-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206912
application number: ANDA206912
PregabalinPREGABALINPreferred Pharmaceuticals Inc.7f29991e-3bf5-4e48-8fa3-6d4e932ed6de2025-09-11Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206912
application number: ANDA206912
PregabalinPREGABALINProficient Rx LPa025e4fc-e0c1-4c5b-a1c8-bd8e578a737e2025-03-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206912
application number: ANDA206912
PregabalinPREGABALINProficient Rx LP2b87989d-6411-4996-8f05-05806ab805252025-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206912
application number: ANDA206912
PregabalinPREGABALINAdvanced Rx Pharmacy of Tennessee, LLCd28168cd-9b7a-f8df-e053-2995a90ad97f2024-12-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206912
application number: ANDA206912
ndc (product): 80425-0178
PregabalinPREGABALINAdvanced Rx Pharmacy of Tennessee, LLCc6b456ca-9d07-7789-e053-2a95a90a20c52024-12-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206912
application number: ANDA206912
ndc (product): 80425-0147
PregabalinPREGABALINAdvanced Rx Pharmacy of Tennessee, LLCc8bfc4f9-6208-4eaa-e053-2a95a90ada972024-12-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206912
application number: ANDA206912
ndc (product): 80425-0170
PregabalinPREGABALINAdvanced Rx Pharmacy of Tennessee, LLCc8acdbcf-3076-63b2-e053-2a95a90aa3c42024-12-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206912
application number: ANDA206912
ndc (product): 80425-0152
PregabalinPREGABALINBryant Ranch Prepackfac0eb4e-12ef-4e8e-8cbe-c43c26f0faee2024-08-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206912
application number: ANDA206912
ndc (product): 71335-1791
PregabalinPREGABALINBryant Ranch Prepackc72b0bed-b7b4-4ae1-914e-756d76b66ed92024-08-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206912
application number: ANDA206912
ndc (product): 71335-1788
PregabalinPREGABALINBryant Ranch Prepackaac1f2f4-5ef5-49dd-b914-54f2cf2b1bc12024-08-12Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206912
application number: ANDA206912
ndc (product): 71335-1789

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 33 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
31722-610PregabalinPregabalinCamber Pharmaceuticals, Inc.ANDACurrent
31722-611PregabalinPregabalinCamber Pharmaceuticals, Inc.ANDACurrent
31722-612PregabalinPregabalinCamber Pharmaceuticals, Inc.ANDACurrent
31722-613PregabalinPregabalinCamber Pharmaceuticals, Inc.ANDACurrent
31722-614PregabalinPregabalinCamber Pharmaceuticals, Inc.ANDACurrent
31722-615PregabalinPregabalinCamber Pharmaceuticals, Inc.ANDACurrent
31722-616PregabalinPregabalinCamber Pharmaceuticals, Inc.ANDACurrent
31722-617PregabalinPregabalinCamber Pharmaceuticals, Inc.ANDACurrent
71335-1788PregabalinPregabalinBryant Ranch PrepackANDACurrent
71335-1788PregabalinPregabalinBryant Ranch PrepackANDACurrent
71335-1789PregabalinPregabalinBryant Ranch PrepackANDACurrent
71335-1789PregabalinPregabalinBryant Ranch PrepackANDACurrent
71335-1789PregabalinPregabalinBryant Ranch PrepackANDACurrent
71335-1790PregabalinPregabalinBryant Ranch PrepackANDACurrent
71335-1790PregabalinPregabalinBryant Ranch PrepackANDACurrent
71335-1790PregabalinPregabalinBryant Ranch PrepackANDACurrent
71335-1791PregabalinPregabalinBryant Ranch PrepackANDACurrent
71335-1791PregabalinPregabalinBryant Ranch PrepackANDACurrent
71335-1792PregabalinPregabalinBryant Ranch PrepackANDACurrent
71335-1792PregabalinPregabalinBryant Ranch PrepackANDACurrent
71335-1822PregabalinPregabalinBryant Ranch PrepackANDACurrent
71335-1822PregabalinPregabalinBryant Ranch PrepackANDACurrent
80425-0147LyricaPregabalin 75mgAdvanced Rx Pharmacy of Tennessee, LLCANDACurrent
80425-0147PregabalinPregabalinAdvanced Rx Pharmacy of Tennessee, LLCANDACurrent
80425-0147PregabalinPregabalinAdvanced Rx Pharmacy of Tennessee, LLCANDACurrent
80425-0152LyricaPregabalin 50mgAdvanced Rx Pharmacy of Tennessee, LLCANDACurrent
80425-0152PregabalinPregabalinAdvanced Rx Pharmacy of Tennessee, LLCANDACurrent
80425-0152PregabalinPregabalinAdvanced Rx Pharmacy of Tennessee, LLCANDACurrent
80425-0170LyricaPregabalin 100mgAdvanced Rx Pharmacy of Tennessee, LLCANDACurrent
80425-0170PregabalinPregabalinAdvanced Rx Pharmacy of Tennessee, LLCANDACurrent
80425-0170PregabalinPregabalinAdvanced Rx Pharmacy of Tennessee, LLCANDACurrent
80425-0178PregabalinPregabalinAdvanced Rx Pharmacy of Tennessee, LLCANDACurrent
80425-0178PregabalinPregabalinAdvanced Rx Pharmacy of Tennessee, LLCANDACurrent