Application 207799

Type
ANDA
Sponsor
ALKEM LABS LTD

Application Products#

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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A207799-001PREGABALINPREGABALIN75MGCAPSULE / ORALAB2019-07-19
A207799-002PREGABALINPREGABALIN100MGCAPSULE / ORALAB2019-07-19
A207799-003PREGABALINPREGABALIN150MGCAPSULE / ORALAB2019-07-19
A207799-004PREGABALINPREGABALIN200MGCAPSULE / ORALAB2019-07-19
A207799-005PREGABALINPREGABALIN225MGCAPSULE / ORALAB2019-07-19
A207799-006PREGABALINPREGABALIN300MGCAPSULE / ORALAB2019-07-19
A207799-007PREGABALINPREGABALIN25MGCAPSULE / ORALAB2019-09-30
A207799-008PREGABALINPREGABALIN50MGCAPSULE / ORALAB2019-09-30

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A207799-001AB
A207799-002AB
A207799-003AB
A207799-004AB
A207799-005AB
A207799-006AB
A207799-007AB
A207799-008AB

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 · 324 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A207799-001PREGABALIN75MGCAPSULE / ORALAB2019-07-1984e616aacf4f…
2026-09-14 22:38:342026-08A207799-002PREGABALIN100MGCAPSULE / ORALAB2019-07-1984e616aacf4f…
2026-09-14 22:38:342026-08A207799-003PREGABALIN150MGCAPSULE / ORALAB2019-07-1984e616aacf4f…
2026-09-14 22:38:342026-08A207799-004PREGABALIN200MGCAPSULE / ORALAB2019-07-1984e616aacf4f…
2026-09-14 22:38:342026-08A207799-005PREGABALIN225MGCAPSULE / ORALAB2019-07-1984e616aacf4f…
2026-09-14 22:38:342026-08A207799-006PREGABALIN300MGCAPSULE / ORALAB2019-07-1984e616aacf4f…
2026-09-14 22:38:342026-08A207799-007PREGABALIN25MGCAPSULE / ORALAB2019-09-3084e616aacf4f…
2026-09-14 22:38:342026-08A207799-008PREGABALIN50MGCAPSULE / ORALAB2019-09-3084e616aacf4f…
2026-08-18 06:07:402026-07A207799-001PREGABALIN75MGCAPSULE / ORALAB2019-07-19caaa826d4ba7…
2026-08-18 06:07:402026-07A207799-002PREGABALIN100MGCAPSULE / ORALAB2019-07-19caaa826d4ba7…
2026-08-18 06:07:402026-07A207799-003PREGABALIN150MGCAPSULE / ORALAB2019-07-19caaa826d4ba7…
2026-08-18 06:07:402026-07A207799-004PREGABALIN200MGCAPSULE / ORALAB2019-07-19caaa826d4ba7…
2026-08-18 06:07:402026-07A207799-005PREGABALIN225MGCAPSULE / ORALAB2019-07-19caaa826d4ba7…
2026-08-18 06:07:402026-07A207799-006PREGABALIN300MGCAPSULE / ORALAB2019-07-19caaa826d4ba7…
2026-08-18 06:07:402026-07A207799-007PREGABALIN25MGCAPSULE / ORALAB2019-09-30caaa826d4ba7…
2026-08-18 06:07:402026-07A207799-008PREGABALIN50MGCAPSULE / ORALAB2019-09-30caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A207799-001PREGABALIN75MGCAPSULE / ORALAB2019-07-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207799-002PREGABALIN100MGCAPSULE / ORALAB2019-07-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207799-003PREGABALIN150MGCAPSULE / ORALAB2019-07-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207799-004PREGABALIN200MGCAPSULE / ORALAB2019-07-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207799-005PREGABALIN225MGCAPSULE / ORALAB2019-07-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207799-006PREGABALIN300MGCAPSULE / ORALAB2019-07-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207799-007PREGABALIN25MGCAPSULE / ORALAB2019-09-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207799-008PREGABALIN50MGCAPSULE / ORALAB2019-09-30011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207799-001PREGABALIN75MGCAPSULE / ORALAB2019-07-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207799-002PREGABALIN100MGCAPSULE / ORALAB2019-07-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207799-003PREGABALIN150MGCAPSULE / ORALAB2019-07-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207799-004PREGABALIN200MGCAPSULE / ORALAB2019-07-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207799-005PREGABALIN225MGCAPSULE / ORALAB2019-07-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207799-006PREGABALIN300MGCAPSULE / ORALAB2019-07-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207799-007PREGABALIN25MGCAPSULE / ORALAB2019-09-3031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207799-008PREGABALIN50MGCAPSULE / ORALAB2019-09-3031067a03dcf5…
2025-08-23 18:47 UTC2025-08A207799-001PREGABALIN75MGCAPSULE / ORALAB2019-07-196a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207799-002PREGABALIN100MGCAPSULE / ORALAB2019-07-196a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207799-003PREGABALIN150MGCAPSULE / ORALAB2019-07-196a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207799-004PREGABALIN200MGCAPSULE / ORALAB2019-07-196a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207799-005PREGABALIN225MGCAPSULE / ORALAB2019-07-196a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207799-006PREGABALIN300MGCAPSULE / ORALAB2019-07-196a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207799-007PREGABALIN25MGCAPSULE / ORALAB2019-09-306a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207799-008PREGABALIN50MGCAPSULE / ORALAB2019-09-306a471c1ec25d…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 9 · 324 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A207799-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A207799-002AB184e616aacf4f…
2026-09-14 22:38:342026-08A207799-003AB184e616aacf4f…
2026-09-14 22:38:342026-08A207799-004AB184e616aacf4f…
2026-09-14 22:38:342026-08A207799-005AB184e616aacf4f…
2026-09-14 22:38:342026-08A207799-006AB184e616aacf4f…
2026-09-14 22:38:342026-08A207799-007AB184e616aacf4f…
2026-09-14 22:38:342026-08A207799-008AB184e616aacf4f…
2026-08-18 06:07:402026-07A207799-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A207799-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A207799-003AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A207799-004AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A207799-005AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A207799-006AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A207799-007AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A207799-008AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A207799-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207799-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207799-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207799-004AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207799-005AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207799-006AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207799-007AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207799-008AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207799-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207799-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207799-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207799-004AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207799-005AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207799-006AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207799-007AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207799-008AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A207799-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207799-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207799-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207799-004AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207799-005AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207799-006AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207799-007AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207799-008AB16a471c1ec25d…

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 · 24 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PregabalinPREGABALINREMEDYREPACK INC.ab06a36d-9a2d-4eae-8991-4eab5bc8311c2026-09-11Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207799
application number: ANDA207799
PregabalinPREGABALINREMEDYREPACK INC.12309847-0857-4ff7-a7e7-edeadc3dfb612026-08-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207799
application number: ANDA207799
ndc (product): 70518-3597
PregabalinPREGABALINREMEDYREPACK INC.47d08b8f-a24d-4159-ab43-2eb67a93559b2026-08-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207799
application number: ANDA207799
PregabalinPREGABALINREMEDYREPACK INC.3c8ea6da-5771-4096-a915-700e51ced05c2026-08-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207799
application number: ANDA207799
PregabalinPREGABALINREMEDYREPACK INC.9c38abbc-2b3d-48d6-b629-4a163c803db52026-08-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207799
application number: ANDA207799
PregabalinPREGABALINREMEDYREPACK INC.efe06a26-30c5-437d-9fd1-4bd0062f12002026-08-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207799
application number: ANDA207799
PregabalinPREGABALINAscend Laboratories, LLCe48db3c2-7351-41f2-a451-5a8341c4125c2026-08-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207799
application number: ANDA207799
ndc (product): 67877-465
ndc (product): 67877-466
ndc (product): 67877-462
ndc (product): 67877-464
ndc (product): 67877-468
ndc (product): 67877-469
ndc (product): 67877-463
ndc (product): 67877-467
PregabalinPREGABALINSt. Mary's Medical Park Pharmacy35d3486c-c6ea-4d31-e063-6294a90a12192026-06-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207799
application number: ANDA207799
PregabalinPREGABALINSt. Mary's Medical Park Pharmacy35d387dd-bc7f-37a4-e063-6394a90abbbb2026-06-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207799
application number: ANDA207799
PregabalinPREGABALINClinical Solutions Wholesale, LLC150c8b71-98b0-4c6b-b20f-fd0fca2d3c262026-06-11Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207799
application number: ANDA207799
PregabalinPREGABALINST. MARY'S MEDICAL PARK PHARMACY3dd7930b-f544-f18b-e063-6294a90a05412026-03-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207799
application number: ANDA207799
PregabalinPREGABALINClinical Solutions Wholesale, LLC613a7a13-d5ba-4827-91ec-3ed5176602b72026-02-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207799
application number: ANDA207799
PregabalinPREGABALINBryant Ranch Prepackb5b22ec1-3fd8-4631-ba7e-98d8e5d030b32025-10-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207799
application number: ANDA207799
ndc (product): 71335-1758
PregabalinPREGABALINPreferred Pharmaceuticals Inc.e8e272a4-c181-4573-822b-2bb315b6ad372025-09-12Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207799
application number: ANDA207799
PregabalinPREGABALINPreferred Pharmaceuticals Inc.a0da0534-b386-4c93-ae89-03b0e3325e022025-09-11Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207799
application number: ANDA207799
PregabalinPREGABALINAdvanced Rx Pharmacy of Tennessee, LLCc89a3514-f637-e54f-e053-2a95a90a68812024-12-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207799
application number: ANDA207799
ndc (product): 80425-0160
PREGABALINPREGABALINAdvanced Rx Pharmacy of Tennessee, LLCd2813712-d7f6-6144-e053-2995a90a3c5d2024-11-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207799
application number: ANDA207799
ndc (product): 80425-0185
PregabalinPREGABALINBryant Ranch Prepack4cda70e8-9ae1-4958-8c86-1bc633be982b2024-09-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207799
application number: ANDA207799
PregabalinPREGABALINBryant Ranch Prepackcf7f0fd0-bac2-4836-9363-79d32ad0cc102024-09-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207799
application number: ANDA207799
ndc (product): 71335-1740
PregabalinPREGABALINBryant Ranch Prepack08ad87e3-e00c-46d1-98f8-df493cf1712e2024-09-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207799
application number: ANDA207799
ndc (product): 71335-1745

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 39 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
67877-462PregabalinPregabalinAscend Laboratories, LLCANDACurrent
67877-463PregabalinPregabalinAscend Laboratories, LLCANDACurrent
67877-464PregabalinPregabalinAscend Laboratories, LLCANDACurrent
67877-464PregabalinPregabalinAscend Laboratories, LLCANDACurrent
67877-464PregabalinPregabalinAscend Laboratories, LLCANDACurrent
67877-465PregabalinPregabalinAscend Laboratories, LLCANDACurrent
67877-465PregabalinPregabalinAscend Laboratories, LLCANDACurrent
67877-465PregabalinPregabalinAscend Laboratories, LLCANDACurrent
67877-466PregabalinPregabalinAscend Laboratories, LLCANDACurrent
67877-466PregabalinPregabalinAscend Laboratories, LLCANDACurrent
67877-466PregabalinPregabalinAscend Laboratories, LLCANDACurrent
67877-467PregabalinPregabalinAscend Laboratories, LLCANDACurrent
67877-467PregabalinPregabalinAscend Laboratories, LLCANDACurrent
67877-467PregabalinPregabalinAscend Laboratories, LLCANDACurrent
67877-468PregabalinPregabalinAscend Laboratories, LLCANDACurrent
67877-468PregabalinPregabalinAscend Laboratories, LLCANDACurrent
67877-468PregabalinPregabalinAscend Laboratories, LLCANDACurrent
67877-469PregabalinPregabalinAscend Laboratories, LLCANDACurrent
67877-469PregabalinPregabalinAscend Laboratories, LLCANDACurrent
67877-469PregabalinPregabalinAscend Laboratories, LLCANDACurrent
70518-3597PregabalinPregabalinREMEDYREPACK INC.ANDACurrent
71205-608PregabalinPregabalinProficient Rx LPANDACurrent
71205-608PregabalinPregabalinProficient Rx LPANDACurrent
71205-621PregabalinPregabalinProficient Rx LPANDACurrent
71205-621PregabalinPregabalinProficient Rx LPANDACurrent
71205-639PregabalinPregabalinProficient Rx LPANDACurrent
71205-639PregabalinPregabalinProficient Rx LPANDACurrent
71335-1740PregabalinPregabalinBryant Ranch PrepackANDACurrent
71335-1740PregabalinPregabalinBryant Ranch PrepackANDACurrent
71335-1745PregabalinPregabalinBryant Ranch PrepackANDACurrent
71335-1745PregabalinPregabalinBryant Ranch PrepackANDACurrent
71335-1758PregabalinPregabalinBryant Ranch PrepackANDACurrent
71335-1758PregabalinPregabalinBryant Ranch PrepackANDACurrent
80425-0160LyricaPregabalin 300mgAdvanced Rx Pharmacy of Tennessee, LLCANDACurrent
80425-0160PregabalinPregabalinAdvanced Rx Pharmacy of Tennessee, LLCANDACurrent
80425-0160PregabalinPregabalinAdvanced Rx Pharmacy of Tennessee, LLCANDACurrent
80425-0160PregabalinPregabalinAdvanced Rx Pharmacy of Tennessee, LLCANDACurrent
80425-0185PREGABALINPREGABALINAdvanced Rx Pharmacy of Tennessee, LLCANDACurrent
80425-0185PREGABALINPREGABALINAdvanced Rx Pharmacy of Tennessee, LLCANDACurrent