Application 078327

Type
ANDA
Sponsor
AUROBINDO PHARMA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001SUMATRIPTAN SUCCINATESUMATRIPTAN SUCCINATETABLET;ORALEQ 25MG BASENoNo
002SUMATRIPTAN SUCCINATESUMATRIPTAN SUCCINATETABLET;ORALEQ 50MG BASENoNo
003SUMATRIPTAN SUCCINATESUMATRIPTAN SUCCINATETABLET;ORALEQ 100MG BASENoNo

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

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A078327-001SUMATRIPTAN SUCCINATESUMATRIPTAN SUCCINATEEQ 25MG BASETABLET / ORALAB2009-08-10
A078327-002SUMATRIPTAN SUCCINATESUMATRIPTAN SUCCINATEEQ 50MG BASETABLET / ORALAB2009-08-10
A078327-003SUMATRIPTAN SUCCINATESUMATRIPTAN SUCCINATEEQ 100MG BASETABLET / ORALAB2009-08-10

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
A078327-001AB
A078327-002AB
A078327-003AB

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 4 · 129 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A078327-001SUMATRIPTAN SUCCINATEEQ 25MG BASETABLET / ORALAB2009-08-1084e616aacf4f…
2026-09-14 22:38:342026-08A078327-002SUMATRIPTAN SUCCINATEEQ 50MG BASETABLET / ORALAB2009-08-1084e616aacf4f…
2026-09-14 22:38:342026-08A078327-003SUMATRIPTAN SUCCINATEEQ 100MG BASETABLET / ORALAB2009-08-1084e616aacf4f…
2026-08-18 06:07:402026-07A078327-001SUMATRIPTAN SUCCINATEEQ 25MG BASETABLET / ORALAB2009-08-10caaa826d4ba7…
2026-08-18 06:07:402026-07A078327-002SUMATRIPTAN SUCCINATEEQ 50MG BASETABLET / ORALAB2009-08-10caaa826d4ba7…
2026-08-18 06:07:402026-07A078327-003SUMATRIPTAN SUCCINATEEQ 100MG BASETABLET / ORALAB2009-08-10caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A078327-001SUMATRIPTAN SUCCINATEEQ 25MG BASETABLET / ORALAB2009-08-10011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078327-002SUMATRIPTAN SUCCINATEEQ 50MG BASETABLET / ORALAB2009-08-10011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078327-003SUMATRIPTAN SUCCINATEEQ 100MG BASETABLET / ORALAB2009-08-10011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078327-001SUMATRIPTAN SUCCINATEEQ 25MG BASETABLET / ORALAB2009-08-1031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078327-002SUMATRIPTAN SUCCINATEEQ 50MG BASETABLET / ORALAB2009-08-1031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078327-003SUMATRIPTAN SUCCINATEEQ 100MG BASETABLET / ORALAB2009-08-1031067a03dcf5…
2025-08-23 18:47 UTC2025-08A078327-001SUMATRIPTAN SUCCINATEEQ 25MG BASETABLET / ORALAB2009-08-106a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078327-002SUMATRIPTAN SUCCINATEEQ 50MG BASETABLET / ORALAB2009-08-106a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078327-003SUMATRIPTAN SUCCINATEEQ 100MG BASETABLET / ORALAB2009-08-106a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078327-001SUMATRIPTAN SUCCINATEEQ 25MG BASETABLET / ORALAB2009-08-10fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078327-002SUMATRIPTAN SUCCINATEEQ 50MG BASETABLET / ORALAB2009-08-10fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078327-003SUMATRIPTAN SUCCINATEEQ 100MG BASETABLET / ORALAB2009-08-10fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078327-001SUMATRIPTAN SUCCINATEEQ 25MG BASETABLET / ORALAB2009-08-10b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078327-002SUMATRIPTAN SUCCINATEEQ 50MG BASETABLET / ORALAB2009-08-10b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078327-003SUMATRIPTAN SUCCINATEEQ 100MG BASETABLET / ORALAB2009-08-10b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078327-001SUMATRIPTAN SUCCINATEEQ 25MG BASETABLET / ORALAB2009-08-1003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078327-002SUMATRIPTAN SUCCINATEEQ 50MG BASETABLET / ORALAB2009-08-1003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078327-003SUMATRIPTAN SUCCINATEEQ 100MG BASETABLET / ORALAB2009-08-1003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078327-001SUMATRIPTAN SUCCINATEEQ 25MG BASETABLET / ORALAB2009-08-102680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078327-002SUMATRIPTAN SUCCINATEEQ 50MG BASETABLET / ORALAB2009-08-102680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078327-003SUMATRIPTAN SUCCINATEEQ 100MG BASETABLET / ORALAB2009-08-102680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078327-001SUMATRIPTAN SUCCINATEEQ 25MG BASETABLET / ORALAB2009-08-105bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078327-002SUMATRIPTAN SUCCINATEEQ 50MG BASETABLET / ORALAB2009-08-105bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078327-003SUMATRIPTAN SUCCINATEEQ 100MG BASETABLET / ORALAB2009-08-105bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078327-001SUMATRIPTAN SUCCINATEEQ 25MG BASETABLET / ORALAB2009-08-10d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078327-002SUMATRIPTAN SUCCINATEEQ 50MG BASETABLET / ORALAB2009-08-10d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078327-003SUMATRIPTAN SUCCINATEEQ 100MG BASETABLET / ORALAB2009-08-10d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A078327-001SUMATRIPTAN SUCCINATEEQ 25MG BASETABLET / ORALAB2009-08-10d06236e962d9…
2024-10-29 15:01 UTC2024-10A078327-002SUMATRIPTAN SUCCINATEEQ 50MG BASETABLET / ORALAB2009-08-10d06236e962d9…
2024-10-29 15:01 UTC2024-10A078327-003SUMATRIPTAN SUCCINATEEQ 100MG BASETABLET / ORALAB2009-08-10d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078327-001SUMATRIPTAN SUCCINATEEQ 25MG BASETABLET / ORALAB2009-08-1079d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078327-002SUMATRIPTAN SUCCINATEEQ 50MG BASETABLET / ORALAB2009-08-1079d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078327-003SUMATRIPTAN SUCCINATEEQ 100MG BASETABLET / ORALAB2009-08-1079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078327-001SUMATRIPTAN SUCCINATEEQ 25MG BASETABLET / ORALAB2009-08-10301d65b070ca…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 129 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A078327-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A078327-002AB184e616aacf4f…
2026-09-14 22:38:342026-08A078327-003AB184e616aacf4f…
2026-08-18 06:07:402026-07A078327-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A078327-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A078327-003AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A078327-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078327-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078327-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078327-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078327-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078327-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A078327-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078327-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078327-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078327-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078327-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078327-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078327-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078327-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078327-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078327-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078327-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078327-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078327-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078327-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078327-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078327-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078327-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078327-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078327-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078327-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078327-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A078327-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A078327-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A078327-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078327-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078327-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078327-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078327-001AB1301d65b070ca…

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 · 21 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SumatriptanSUMATRIPTAN SUCCINATEPreferred Pharmaceuticals, Inc.bf9fd9fe-095b-4478-bd2e-a5534af077612026-09-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078327
application number: ANDA078327
ndc (product): 68788-6778
SumatriptanSUMATRIPTAN SUCCINATEPreferred Pharmaceuticals Inc.baf37e8c-d414-4ca7-a366-97dc202372ff2026-09-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078327
application number: ANDA078327
ndc (product): 68788-6769
SumatriptanSUMATRIPTAN SUCCINATEREMEDYREPACK INC.73c9ac06-b55e-41e0-90ec-deb250f37eb52026-05-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078327
application number: ANDA078327
ndc (product): 70518-1184
SumatriptanSUMATRIPTAN SUCCINATEAurobindo Pharma Limitedb2503fff-c978-4efa-b1b4-d7740b6b26f22026-05-12Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078327
application number: ANDA078327
SumatriptanSUMATRIPTAN SUCCINATESportpharm LLCd071aef6-a5bd-4f68-ba6d-03004466897c2026-04-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078327
application number: ANDA078327
SumatriptanSUMATRIPTAN SUCCINATEA-S Medication Solutions62ba6fef-467a-4500-993c-51907f12a67c2026-02-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078327
application number: ANDA078327
SumatriptanSUMATRIPTAN SUCCINATENorthStar Rx LLC84bfc4ba-4172-4adb-b963-4e0eb438c07a2026-02-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078327
application number: ANDA078327
SumatriptanSUMATRIPTAN SUCCINATEPreferred Pharmaceuticals, Inc.f2e7d756-1e12-462a-a43f-a9d860b11ee82025-09-25Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078327
application number: ANDA078327
ndc (product): 68788-9547
SumatriptanSUMATRIPTAN SUCCINATENuCare Pharmaceuticals, Inc.2efd4269-5657-9669-e063-6394a90a583a2025-02-25Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078327
application number: ANDA078327
SumatriptanSUMATRIPTAN SUCCINATENuCare Pharmaceuticals, Inc.2a96f37d-03f6-678c-e063-6394a90ae0c62024-12-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078327
application number: ANDA078327
SumatriptanSUMATRIPTANAdvanced Rx of Tennessee, LLCf1a118cf-2179-572a-e053-2995a90acbb02024-12-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078327
application number: ANDA078327
SumatriptanSUMATRIPTAN SUCCINATEQuality Care Products, LLC5d1f3de0-684a-4092-be30-aa325ff20d042024-12-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078327
application number: ANDA078327
SumatriptanSUMATRIPTAN SUCCINATEQuality Care Products, LLCda77dfc4-551c-4e0e-a65e-cb478f193cd92024-12-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078327
application number: ANDA078327
SumatriptanSUMATRIPTANAdvanced Rx Pharmacy of Tennessee, LLCf8c4bbfb-1586-4610-e053-6394a90a8f092024-08-27Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078327
application number: ANDA078327
SumatriptanSUMATRIPTAN SUCCINATENuCare Pharmaceuticals,Inc.54c6f8f4-5466-3988-e054-00144ff8d46c2024-07-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078327
application number: ANDA078327
SumatriptanSUMATRIPTAN SUCCINATENuCare Pharmaceuticals,Inc.933f6575-a4c4-0f65-e053-2a95a90ab9672024-06-19Exact identifier
application applno (ANDA): 078327
application number: ANDA078327
SumatriptanSUMATRIPTAN SUCCINATENuCare Pharmaceuticals,Inc.85295be9-852d-4e21-e053-2991aa0a8a782024-06-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078327
application number: ANDA078327
SumatriptanSUMATRIPTAN SUCCINATEProficient Rx LPfe09fab6-b9e3-469c-9a38-bcc343dcc8992023-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078327
application number: ANDA078327
SumatriptanSUMATRIPTAN SUCCINATEAsclemed USA, Inc.77f9f135-e840-48f0-81e8-73e08433e7682022-10-11Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078327
application number: ANDA078327
ndc (product): 76420-500
ndc (product): 76420-498
ndc (product): 76420-499
SumatriptanSUMATRIPTAN SUCCINATEProficient Rx LPabbd2168-1523-4eb6-a75c-dc4d7d1b1c9b2022-06-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078327
application number: ANDA078327

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 2 of 2 · 106 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
68788-6769SumatriptanSumatriptan SuccinatePreferred Pharmaceuticals Inc.ANDACurrent
68788-6769SumatriptanSumatriptan SuccinatePreferred Pharmaceuticals Inc.ANDACurrent
68788-6769SumatriptanSumatriptan SuccinatePreferred Pharmaceuticals Inc.ANDACurrent
68788-6769SumatriptanSumatriptan SuccinatePreferred PharmaceuticalsANDACurrent
68788-6769SumatriptanSumatriptan SuccinatePreferred Pharmaceuticals Inc.ANDACurrent
68788-6778SumatriptanSumatriptan SuccinatePreferred PharmaceuticalsANDACurrent
68788-6778SumatriptanSumatriptan SuccinatePreferred Pharmaceuticals, Inc.ANDACurrent
68788-6778SumatriptanSumatriptan SuccinatePreferred Pharmaceuticals, Inc.ANDACurrent
68788-6778SumatriptanSumatriptan SuccinatePreferred Pharmaceuticals, Inc.ANDACurrent
68788-6778SumatriptanSumatriptan SuccinatePreferred Pharmaceuticals, Inc.ANDACurrent
68788-9547SumatriptanSumatriptan SuccinatePreferred Pharmaceuticals, Inc.ANDACurrent
68788-9547SumatriptanSumatriptan SuccinatePreferred Pharmaceuticals, Inc.ANDACurrent
68788-9547SumatriptanSumatriptan SuccinatePreferred Pharmaceuticals, Inc.ANDACurrent
68788-9547SumatriptanSumatriptan SuccinatePreferred PharmaceuticalsANDACurrent
68788-9547SumatriptanSumatriptan SuccinatePreferred Pharmaceuticals, Inc.ANDACurrent
69176-150Migraine PackSumatriptan Succinate, MENTHOLUM, BELLADONNA, IRIS VERSICOLOR, SANGUINARIA CANADENSISTMIG IncANDACurrent
70518-0041SumatriptanSumatriptan SuccinateREMEDYREPACK INC.ANDACurrent
70518-0041SumatriptanSumatriptan SuccinateREMEDYREPACK INC.ANDACurrent
70518-1184SumatriptanSumatriptan SuccinateREMEDYREPACK INC.ANDACurrent
70518-1184SumatriptanSumatriptan SuccinateREMEDYREPACK INC.ANDACurrent
70518-1184SumatriptanSumatriptan SuccinateREMEDYREPACK INC.ANDACurrent
70518-1184SumatriptanSumatriptan SuccinateREMEDYREPACK INC.ANDACurrent
70518-1184SumatriptanSumatriptan SuccinateREMEDYREPACK INC.ANDACurrent
76420-498SumatriptanSumatriptan SuccinateAsclemed USA, Inc.ANDACurrent
76420-499SumatriptanSumatriptan SuccinateAsclemed USA, Inc.ANDACurrent
76420-500SumatriptanSumatriptan SuccinateAsclemed USA, Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
9143ORIG2009-08-14