Application 208677

Type
ANDA
Sponsor
SCIEGEN PHARMS INC

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 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
A208677-001PREGABALINPREGABALIN25MGCAPSULE / ORALAB2019-07-19
A208677-002PREGABALINPREGABALIN50MGCAPSULE / ORALAB2019-07-19
A208677-003PREGABALINPREGABALIN75MGCAPSULE / ORALAB2019-07-19
A208677-004PREGABALINPREGABALIN100MGCAPSULE / ORALAB2019-07-19
A208677-005PREGABALINPREGABALIN150MGCAPSULE / ORALAB2019-07-19
A208677-006PREGABALINPREGABALIN200MGCAPSULE / ORALAB2019-07-19
A208677-007PREGABALINPREGABALIN225MGCAPSULE / ORALAB2019-07-19
A208677-008PREGABALINPREGABALIN300MGCAPSULE / 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
A208677-001AB
A208677-002AB
A208677-003AB
A208677-004AB
A208677-005AB
A208677-006AB
A208677-007AB
A208677-008AB

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 · 336 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A208677-001PREGABALIN25MGCAPSULE / ORALAB2019-07-1984e616aacf4f…
2026-09-14 22:38:342026-08A208677-002PREGABALIN50MGCAPSULE / ORALAB2019-07-1984e616aacf4f…
2026-09-14 22:38:342026-08A208677-003PREGABALIN75MGCAPSULE / ORALAB2019-07-1984e616aacf4f…
2026-09-14 22:38:342026-08A208677-004PREGABALIN100MGCAPSULE / ORALAB2019-07-1984e616aacf4f…
2026-09-14 22:38:342026-08A208677-005PREGABALIN150MGCAPSULE / ORALAB2019-07-1984e616aacf4f…
2026-09-14 22:38:342026-08A208677-006PREGABALIN200MGCAPSULE / ORALAB2019-07-1984e616aacf4f…
2026-09-14 22:38:342026-08A208677-007PREGABALIN225MGCAPSULE / ORALAB2019-07-1984e616aacf4f…
2026-09-14 22:38:342026-08A208677-008PREGABALIN300MGCAPSULE / ORALAB2019-07-1984e616aacf4f…
2026-08-18 06:07:402026-07A208677-001PREGABALIN25MGCAPSULE / ORALAB2019-07-19caaa826d4ba7…
2026-08-18 06:07:402026-07A208677-002PREGABALIN50MGCAPSULE / ORALAB2019-07-19caaa826d4ba7…
2026-08-18 06:07:402026-07A208677-003PREGABALIN75MGCAPSULE / ORALAB2019-07-19caaa826d4ba7…
2026-08-18 06:07:402026-07A208677-004PREGABALIN100MGCAPSULE / ORALAB2019-07-19caaa826d4ba7…
2026-08-18 06:07:402026-07A208677-005PREGABALIN150MGCAPSULE / ORALAB2019-07-19caaa826d4ba7…
2026-08-18 06:07:402026-07A208677-006PREGABALIN200MGCAPSULE / ORALAB2019-07-19caaa826d4ba7…
2026-08-18 06:07:402026-07A208677-007PREGABALIN225MGCAPSULE / ORALAB2019-07-19caaa826d4ba7…
2026-08-18 06:07:402026-07A208677-008PREGABALIN300MGCAPSULE / ORALAB2019-07-19caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A208677-001PREGABALIN25MGCAPSULE / ORALAB2019-07-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02A208677-002PREGABALIN50MGCAPSULE / ORALAB2019-07-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02A208677-003PREGABALIN75MGCAPSULE / ORALAB2019-07-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02A208677-004PREGABALIN100MGCAPSULE / ORALAB2019-07-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02A208677-005PREGABALIN150MGCAPSULE / ORALAB2019-07-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02A208677-006PREGABALIN200MGCAPSULE / ORALAB2019-07-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02A208677-007PREGABALIN225MGCAPSULE / ORALAB2019-07-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02A208677-008PREGABALIN300MGCAPSULE / ORALAB2019-07-19011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208677-001PREGABALIN25MGCAPSULE / ORALAB2019-07-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208677-002PREGABALIN50MGCAPSULE / ORALAB2019-07-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208677-003PREGABALIN75MGCAPSULE / ORALAB2019-07-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208677-004PREGABALIN100MGCAPSULE / ORALAB2019-07-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208677-005PREGABALIN150MGCAPSULE / ORALAB2019-07-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208677-006PREGABALIN200MGCAPSULE / ORALAB2019-07-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208677-007PREGABALIN225MGCAPSULE / ORALAB2019-07-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208677-008PREGABALIN300MGCAPSULE / ORALAB2019-07-1931067a03dcf5…
2025-08-23 18:47 UTC2025-08A208677-001PREGABALIN25MGCAPSULE / ORALAB2019-07-196a471c1ec25d…
2025-08-23 18:47 UTC2025-08A208677-002PREGABALIN50MGCAPSULE / ORALAB2019-07-196a471c1ec25d…
2025-08-23 18:47 UTC2025-08A208677-003PREGABALIN75MGCAPSULE / ORALAB2019-07-196a471c1ec25d…
2025-08-23 18:47 UTC2025-08A208677-004PREGABALIN100MGCAPSULE / ORALAB2019-07-196a471c1ec25d…
2025-08-23 18:47 UTC2025-08A208677-005PREGABALIN150MGCAPSULE / ORALAB2019-07-196a471c1ec25d…
2025-08-23 18:47 UTC2025-08A208677-006PREGABALIN200MGCAPSULE / ORALAB2019-07-196a471c1ec25d…
2025-08-23 18:47 UTC2025-08A208677-007PREGABALIN225MGCAPSULE / ORALAB2019-07-196a471c1ec25d…
2025-08-23 18:47 UTC2025-08A208677-008PREGABALIN300MGCAPSULE / ORALAB2019-07-196a471c1ec25d…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 9 · 336 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A208677-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A208677-002AB184e616aacf4f…
2026-09-14 22:38:342026-08A208677-003AB184e616aacf4f…
2026-09-14 22:38:342026-08A208677-004AB184e616aacf4f…
2026-09-14 22:38:342026-08A208677-005AB184e616aacf4f…
2026-09-14 22:38:342026-08A208677-006AB184e616aacf4f…
2026-09-14 22:38:342026-08A208677-007AB184e616aacf4f…
2026-09-14 22:38:342026-08A208677-008AB184e616aacf4f…
2026-08-18 06:07:402026-07A208677-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A208677-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A208677-003AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A208677-004AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A208677-005AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A208677-006AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A208677-007AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A208677-008AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A208677-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A208677-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A208677-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A208677-004AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A208677-005AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A208677-006AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A208677-007AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A208677-008AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208677-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208677-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208677-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208677-004AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208677-005AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208677-006AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208677-007AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208677-008AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A208677-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A208677-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A208677-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A208677-004AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A208677-005AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A208677-006AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A208677-007AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A208677-008AB16a471c1ec25d…

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 5 · 87 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PregabalinPREGABALINSt. Mary's Medical Park Pharmacy923745e9-17a2-a5f7-e053-2a95a90aed382026-09-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208677
application number: ANDA208677
PregabalinPREGABALINPreferred Pharmaceuticals, Inc.ce1419bc-c348-4407-b320-e0598d5a7b192026-08-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208677
application number: ANDA208677
PregabalinPREGABALINSt. Mary's Medical Park Pharmacyfc5dd378-950f-949b-e053-6394a90a3ca22026-07-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208677
application number: ANDA208677
PregabalinPREGABALINSt. Mary's Medical Park Pharmacy9235cd08-7a25-4b81-e053-2995a90a539c2026-07-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208677
application number: ANDA208677
PregabalinPREGABALINST. MARY'S MEDICAL PARK PHARMACY923743f0-f557-9143-e053-2a95a90a21ae2026-06-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208677
application number: ANDA208677
PregabalinPREGABALINBryant Ranch Prepack45abbcb4-6a38-469d-9671-24b2c25e5b182026-05-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208677
application number: ANDA208677
PregabalinPREGABALINAphena Pharma Solutions - Tennessee, LLC4ddf9ede-5e8b-b5e1-e063-6394a90ac7f32026-05-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208677
application number: ANDA208677
PregabalinPREGABALINAphena Pharma Solutions - Tennessee, LLC4d53c8e2-f03f-0f5b-e063-6294a90a23c62026-04-27Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208677
application number: ANDA208677
PregabalinPREGABALINAphena Pharma Solutions - Tennessee, LLC4ef59b1c-1273-5e54-e063-6294a90a0ec92026-04-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208677
application number: ANDA208677
PregabalinPREGABALINBryant Ranch Prepack1a8d8292-1f94-46da-bade-8c40542013432026-04-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208677
application number: ANDA208677
PregabalinPREGABALINBryant Ranch Prepackb977269a-7d62-44a2-bd0d-11c54b8728362026-04-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208677
application number: ANDA208677
PregabalinPREGABALINBryant Ranch Prepackfd01590e-5b90-4a77-ad5f-76adabf3c32e2026-04-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208677
application number: ANDA208677
PregabalinPREGABALINAphena Pharma Solutions - Tennessee, LLC4d63908b-96be-554c-e063-6394a90af5102026-04-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208677
application number: ANDA208677
PregabalinPREGABALINBryant Ranch Prepack8a7acea4-108d-40d2-a2a7-36088be972482026-04-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208677
application number: ANDA208677
PregabalinPREGABALINBryant Ranch Prepack025c3adb-5f6b-45f5-a4c6-cea8e57102e32026-04-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208677
application number: ANDA208677
PregabalinPREGABALINBryant Ranch Prepack2ceccc4d-97e2-4eb0-841f-23609187710c2026-04-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208677
application number: ANDA208677
PregabalinPREGABALINBryant Ranch Prepack247aedca-ae27-44c6-b32c-c95d264545662026-04-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208677
application number: ANDA208677
PregabalinPREGABALINBryant Ranch Prepacke1ed81bc-1597-4bc5-80cd-09977a154e4b2026-04-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208677
application number: ANDA208677
PregabalinPREGABALINBryant Ranch Prepackfd568ede-dac7-4910-bb18-65fb00f2636e2026-04-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208677
application number: ANDA208677
PregabalinPREGABALINProficient Rx LP32789571-a566-46fa-ba41-bd3c86276ecf2026-04-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208677
application number: ANDA208677

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 3 of 4 · 266 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
68788-7524PregabalinPREGABALINPreferred Pharmaceuticals, Inc.ANDACurrent
68788-7524PregabalinPREGABALINPreferred Pharmaceuticals, Inc.ANDACurrent
68788-7524PregabalinPREGABALINPreferred Pharmaceuticals, Inc.ANDACurrent
68788-7527PregabalinPREGABALINPreferred Pharmaceuticals, Inc.ANDACurrent
68788-7527PregabalinPREGABALINPreferred Pharmaceuticals, Inc.ANDACurrent
68788-7527PregabalinPREGABALINPreferred Pharmaceuticals, Inc.ANDACurrent
68788-7527PregabalinPREGABALINPreferred Pharmaceuticals, Inc.ANDACurrent
68788-7656PregabalinPREGABALINPreferred Pharmaceuticals, Inc.ANDACurrent
68788-7656PregabalinPREGABALINPreferred Pharmaceuticals, Inc.ANDACurrent
68788-7656PregabalinPREGABALINPreferred Pharmaceuticals, Inc.ANDACurrent
69367-324PregabalinPregabalinWestminster Pharmaceuticals, LLCANDACurrent
69367-325PregabalinPregabalinWestminster Pharmaceuticals, LLCANDACurrent
69367-326PregabalinPregabalinWestminster Pharmaceuticals, LLCANDACurrent
69367-327PregabalinPregabalinWestminster Pharmaceuticals, LLCANDACurrent
69367-328PregabalinPregabalinWestminster Pharmaceuticals, LLCANDACurrent
69367-329PregabalinPregabalinWestminster Pharmaceuticals, LLCANDACurrent
69367-330PregabalinPregabalinWestminster Pharmaceuticals, LLCANDACurrent
69367-331PregabalinPregabalinWestminster Pharmaceuticals, LLCANDACurrent
71205-304PregabalinPREGABALINProficient Rx LPANDACurrent
71205-304PregabalinPREGABALINProficient Rx LPANDACurrent
71205-304PregabalinPREGABALINProficient Rx LPANDACurrent
71205-304PregabalinPREGABALINProficient Rx LPANDACurrent
71205-323PregabalinPREGABALINProficient Rx LPANDACurrent
71205-323PregabalinPREGABALINProficient Rx LPANDACurrent
71205-396PregabalinPREGABALINProficient Rx LPANDACurrent
71205-396PregabalinPREGABALINProficient Rx LPANDACurrent
71205-556PregabalinPREGABALINProficient Rx LPANDACurrent
71205-556PregabalinPREGABALINProficient Rx LPANDACurrent
71205-677PregabalinPregabalinProficient Rx LPANDACurrent
71205-694PregabalinPregabalinProficient Rx LPANDACurrent
71205-869PregabalinPregabalinProficient Rx LPANDACurrent
71205-869PregabalinPregabalinProficient Rx LPANDACurrent
71205-870PregabalinPregabalinProficient Rx LPANDACurrent
71205-870PregabalinPregabalinProficient Rx LPANDACurrent
71205-871PregabalinPregabalinProficient Rx LPANDACurrent
71205-871PregabalinPregabalinProficient Rx LPANDACurrent
71205-872PregabalinPregabalinProficient Rx LPANDACurrent
71205-872PregabalinPregabalinProficient Rx LPANDACurrent
71205-873PregabalinPregabalinProficient Rx LPANDACurrent
71205-873PregabalinPregabalinProficient Rx LPANDACurrent
71205-874PregabalinPregabalinProficient Rx LPANDACurrent
71205-874PregabalinPregabalinProficient Rx LPANDACurrent
71205-875PregabalinPregabalinProficient Rx LPANDACurrent
71205-875PregabalinPregabalinProficient Rx LPANDACurrent
71205-876PregabalinPregabalinProficient Rx LPANDACurrent
71205-876PregabalinPregabalinProficient Rx LPANDACurrent
71610-328PregabalinPREGABALINAphena Pharma Solutions - Tennessee, LLCANDACurrent
71610-329PregabalinPREGABALINAphena Pharma Solutions - Tennessee, LLCANDACurrent
71610-330PregabalinPREGABALINAphena Pharma Solutions - Tennessee, LLCANDACurrent
71610-331PregabalinPREGABALINAphena Pharma Solutions - Tennessee, LLCANDACurrent
71610-332PregabalinPREGABALINAphena Pharma Solutions - Tennessee, LLCANDACurrent
71610-333PregabalinPREGABALINAphena Pharma Solutions - Tennessee, LLCANDACurrent
71610-334PregabalinPREGABALINAphena Pharma Solutions - Tennessee, LLCANDACurrent
71610-335PregabalinPREGABALINAphena Pharma Solutions - Tennessee, LLCANDACurrent
71610-618PregabalinPREGABALINAphena Pharma Solutions - Tennessee, LLCANDACurrent
71610-618PregabalinPREGABALINAphena Pharma Solutions - Tennessee, LLCANDACurrent
71610-619PregabalinPREGABALINAphena Pharma Solutions - Tennessee, LLCANDACurrent
71610-619PregabalinPREGABALINAphena Pharma Solutions - Tennessee, LLCANDACurrent
71610-677PregabalinPREGABALINAphena Pharma Solutions - Tennessee, LLCANDACurrent
72189-019PREGABALINPREGABALINDirect_RxANDACurrent
72189-019PREGABALINPREGABALINDirect_RxANDACurrent
72189-019PREGABALINPREGABALINDirect_RxANDACurrent
72189-019PREGABALINPREGABALINDirect_RxANDACurrent
72189-020PREGABALINPREGABALINDirect_RxANDACurrent
72189-020PREGABALINPREGABALINDirect_RxANDACurrent
72189-020PREGABALINPREGABALINDirect_RxANDACurrent
72189-021PREGABALINPREGABALINDirect_RxANDACurrent
72189-021PREGABALINPREGABALINDirect_RxANDACurrent
72189-023PREGABALINPREGABALINDirect_RxANDACurrent
72189-023PREGABALINPREGABALINDirect_RxANDACurrent
72189-023PREGABALINPREGABALINDirect_RxANDACurrent
72189-241PREGABALINPREGABALINDirect_RxANDACurrent
72189-241PREGABALINPREGABALINDirect_RxANDACurrent
72189-241PREGABALINPREGABALINDirect_RxANDACurrent
72189-241PREGABALINPREGABALINDirect_RxANDACurrent
72189-251PREGABALINPREGABALINDirect_RxANDACurrent
72189-251PREGABALINPREGABALINDirect_RxANDACurrent
72189-251PREGABALINPREGABALINDirect_RxANDACurrent
72189-251PREGABALINPREGABALINDirect_RxANDACurrent
72189-269PREGABALINPREGABALINDirect_RxANDACurrent