Application 076847

Type
ANDA
Sponsor
DR REDDYS LABS INC

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 1.

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
A076847-001SUMATRIPTAN SUCCINATESUMATRIPTAN SUCCINATEEQ 25MG BASETABLET / ORALAB2009-08-10
A076847-002SUMATRIPTAN SUCCINATESUMATRIPTAN SUCCINATEEQ 50MG BASETABLET / ORALAB2009-08-10
A076847-003SUMATRIPTAN 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
A076847-001AB
A076847-002AB
A076847-003AB

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 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A076847-001SUMATRIPTAN SUCCINATEEQ 25MG BASETABLET / ORALAB2009-08-10011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076847-002SUMATRIPTAN SUCCINATEEQ 50MG BASETABLET / ORALAB2009-08-10011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076847-003SUMATRIPTAN SUCCINATEEQ 100MG BASETABLET / ORALAB2009-08-10011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076847-001SUMATRIPTAN SUCCINATEEQ 25MG BASETABLET / ORALAB2009-08-1031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076847-002SUMATRIPTAN SUCCINATEEQ 50MG BASETABLET / ORALAB2009-08-1031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076847-003SUMATRIPTAN SUCCINATEEQ 100MG BASETABLET / ORALAB2009-08-1031067a03dcf5…
2025-08-23 18:47 UTC2025-08A076847-001SUMATRIPTAN SUCCINATEEQ 25MG BASETABLET / ORALAB2009-08-106a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076847-002SUMATRIPTAN SUCCINATEEQ 50MG BASETABLET / ORALAB2009-08-106a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076847-003SUMATRIPTAN SUCCINATEEQ 100MG BASETABLET / ORALAB2009-08-106a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076847-001SUMATRIPTAN SUCCINATEEQ 25MG BASETABLET / ORALAB2009-08-10fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076847-002SUMATRIPTAN SUCCINATEEQ 50MG BASETABLET / ORALAB2009-08-10fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076847-003SUMATRIPTAN SUCCINATEEQ 100MG BASETABLET / ORALAB2009-08-10fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076847-001SUMATRIPTAN SUCCINATEEQ 25MG BASETABLET / ORALAB2009-08-10b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076847-002SUMATRIPTAN SUCCINATEEQ 50MG BASETABLET / ORALAB2009-08-10b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076847-003SUMATRIPTAN SUCCINATEEQ 100MG BASETABLET / ORALAB2009-08-10b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076847-001SUMATRIPTAN SUCCINATEEQ 25MG BASETABLET / ORALAB2009-08-1003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076847-002SUMATRIPTAN SUCCINATEEQ 50MG BASETABLET / ORALAB2009-08-1003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076847-003SUMATRIPTAN SUCCINATEEQ 100MG BASETABLET / ORALAB2009-08-1003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076847-001SUMATRIPTAN SUCCINATEEQ 25MG BASETABLET / ORALAB2009-08-102680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076847-002SUMATRIPTAN SUCCINATEEQ 50MG BASETABLET / ORALAB2009-08-102680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076847-003SUMATRIPTAN SUCCINATEEQ 100MG BASETABLET / ORALAB2009-08-102680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076847-001SUMATRIPTAN SUCCINATEEQ 25MG BASETABLET / ORALAB2009-08-105bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076847-002SUMATRIPTAN SUCCINATEEQ 50MG BASETABLET / ORALAB2009-08-105bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076847-003SUMATRIPTAN SUCCINATEEQ 100MG BASETABLET / ORALAB2009-08-105bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076847-001SUMATRIPTAN SUCCINATEEQ 25MG BASETABLET / ORALAB2009-08-10d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076847-002SUMATRIPTAN SUCCINATEEQ 50MG BASETABLET / ORALAB2009-08-10d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076847-003SUMATRIPTAN SUCCINATEEQ 100MG BASETABLET / ORALAB2009-08-10d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A076847-001SUMATRIPTAN SUCCINATEEQ 25MG BASETABLET / ORALAB2009-08-10d06236e962d9…
2024-10-29 15:01 UTC2024-10A076847-002SUMATRIPTAN SUCCINATEEQ 50MG BASETABLET / ORALAB2009-08-10d06236e962d9…
2024-10-29 15:01 UTC2024-10A076847-003SUMATRIPTAN SUCCINATEEQ 100MG BASETABLET / ORALAB2009-08-10d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076847-001SUMATRIPTAN SUCCINATEEQ 25MG BASETABLET / ORALAB2009-08-1079d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076847-002SUMATRIPTAN SUCCINATEEQ 50MG BASETABLET / ORALAB2009-08-1079d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076847-003SUMATRIPTAN SUCCINATEEQ 100MG BASETABLET / ORALAB2009-08-1079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076847-001SUMATRIPTAN SUCCINATEEQ 25MG BASETABLET / ORALAB2009-08-10301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076847-002SUMATRIPTAN SUCCINATEEQ 50MG BASETABLET / ORALAB2009-08-10301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076847-003SUMATRIPTAN SUCCINATEEQ 100MG BASETABLET / ORALAB2009-08-10301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076847-001SUMATRIPTAN SUCCINATEEQ 25MG BASETABLET / ORALAB2009-08-101e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076847-002SUMATRIPTAN SUCCINATEEQ 50MG BASETABLET / ORALAB2009-08-101e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076847-003SUMATRIPTAN SUCCINATEEQ 100MG BASETABLET / ORALAB2009-08-101e350fbaab3a…
2024-05-31 18:47 UTC2024-05A076847-001SUMATRIPTAN SUCCINATEEQ 25MG BASETABLET / ORALAB2009-08-108072bd15b7f6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A076847-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076847-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076847-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076847-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076847-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076847-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A076847-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076847-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076847-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076847-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076847-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076847-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076847-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076847-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076847-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076847-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076847-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076847-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076847-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076847-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076847-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076847-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076847-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076847-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076847-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076847-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076847-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A076847-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A076847-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A076847-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076847-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076847-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076847-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076847-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076847-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076847-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076847-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076847-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076847-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A076847-001AB18072bd15b7f6…

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 · 7 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sumatriptan SuccinateSUMATRIPTAN SUCCINATEDr. Reddy's Laboratories Limitedac80d018-6abf-2e41-ddea-90b4ff9e90132026-03-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076847
application number: ANDA076847
ndc (product): 55111-293
ndc (product): 55111-292
ndc (product): 55111-291
Sumatriptan SuccinateSUMATRIPTAN SUCCINATENuCare Pharmaceuticals,Inc.7628caf4-5272-4e42-e053-2a91aa0a2f242025-01-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076847
application number: ANDA076847
ndc (product): 68071-4562
Sumatriptan SuccinateSUMATRIPTAN SUCCINATENuCare Pharmaceuticals,Inc.b297a466-7d24-9ebd-e053-2a95a90af4d12024-07-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076847
application number: ANDA076847
ndc (product): 68071-2283
Sumatriptan SuccinateSUMATRIPTAN SUCCINATEAsclemed USA, Inc.b16886d0-224b-4d83-85c4-bc3eb3606c172020-10-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076847
application number: ANDA076847
ndc (product): 76420-093
Sumatriptan SuccinateSUMATRIPTAN SUCCINATEProficient Rx LP68daf82a-334e-43ca-b4bb-5c66a82f52c82020-02-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076847
application number: ANDA076847
ndc (product): 63187-049
Sumatriptan SuccinateSUMATRIPTAN SUCCINATEProficient Rx LP77a41cca-02d2-4b84-975e-d1925f0fca802019-11-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076847
application number: ANDA076847
ndc (product): 63187-617
Sumatriptan SuccinateSUMATRIPTAN SUCCINATEProficient Rx LPd9c78ac5-7328-4204-8f66-96606d7db5c32019-11-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076847
application number: ANDA076847
ndc (product): 63187-607

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 48 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
21695-872Sumatriptan SuccinateSumatriptan SuccinateRebel Distributors CorpANDACurrent
21695-873Sumatriptan SuccinateSumatriptan SuccinateRebel Distributors CorpANDACurrent
21695-874Sumatriptan SuccinateSumatriptan SuccinateRebel Distributors CorpANDACurrent
35356-438Sumatriptan SuccinateSumatriptan SuccinateLake Erie Medical DBA Quality Care Products LLCANDACurrent
35356-438Sumatriptan SuccinateSumatriptan SuccinateLake Erie Medical DBA Quality Care Products LLCANDACurrent
35356-438Sumatriptan SuccinateSumatriptan SuccinateLake Erie Medical DBA Quality Care Products LLCANDACurrent
35356-438Sumatriptan SuccinateSumatriptan SuccinateQuality Care Products, LLCANDACurrent
35356-439Sumatriptan SuccinateSumatriptan SuccinateLake Erie Medical DBA Quality Care Products LLCANDACurrent
35356-439Sumatriptan SuccinateSumatriptan SuccinateLake Erie Medical DBA Quality Care Products LLCANDACurrent
35356-439Sumatriptan SuccinateSumatriptan SuccinateQuality Care Products, LLCANDACurrent
45865-570Sumatriptan SuccinateSumatriptan SuccinateMedsource PharmaceuticalsANDACurrent
45865-570Sumatriptan SuccinateSumatriptan SuccinateMedsource PharmaceuticalsANDACurrent
50090-1765Sumatriptan SuccinateSumatriptan SuccinateA-S Medication SolutionsANDACurrent
50090-2916Sumatriptan SuccinateSumatriptan SuccinateA-S Medication SolutionsANDACurrent
50436-4624Sumatriptan SuccinateSumatriptan SuccinateUnit Dose ServicesANDACurrent
52959-510Sumatriptan SuccinateSumatriptan SuccinateH.J. Harkins Company, Inc.ANDACurrent
53002-1592Sumatriptan SuccinateSumatriptan SuccinateRPK Pharmaceuticals, Inc.ANDACurrent
53002-1592Sumatriptan SuccinateSumatriptan SuccinateRPK Pharmaceuticals, Inc.ANDACurrent
53002-1593Sumatriptan SuccinateSumatriptan SuccinateRPK Pharmaceuticals, Inc.ANDACurrent
53002-1593Sumatriptan SuccinateSumatriptan SuccinateRPK Pharmaceuticals, Inc.ANDACurrent
53002-2562Sumatriptan SuccinateSumatriptan SuccinateRPK Pharmaceuticals, Inc.ANDACurrent
55111-291Sumatriptan SuccinateSumatriptan SuccinateDr. Reddy's Laboratories LimitedANDACurrent
55111-291Sumatriptan SuccinateSumatriptan SuccinateDr. Reddy's Laboratories LimitedANDACurrent
55111-291Sumatriptan SuccinateSumatriptan SuccinateDr. Reddy's Laboratories LimitedANDACurrent
55111-292Sumatriptan SuccinateSumatriptan SuccinateDr. Reddy's Laboratories LimitedANDACurrent
55111-292Sumatriptan SuccinateSumatriptan SuccinateDr. Reddy's Laboratories LimitedANDACurrent
55111-292Sumatriptan SuccinateSumatriptan SuccinateDr. Reddy's Laboratories LimitedANDACurrent
55111-293Sumatriptan SuccinateSumatriptan SuccinateDr. Reddy's Laboratories LimitedANDACurrent
55111-293Sumatriptan SuccinateSumatriptan SuccinateDr. Reddy's Laboratories LimitedANDACurrent
55111-293Sumatriptan SuccinateSumatriptan SuccinateDr. Reddy's Laboratories LimitedANDACurrent
55700-235Sumatriptan SuccinateSumatriptan SuccinateLake Erie Medical DBA Quality Care Products LLCANDACurrent
63187-049Sumatriptan SuccinateSumatriptan SuccinateProficient Rx LPANDACurrent
63187-049Sumatriptan SuccinateSumatriptan SuccinateProficient Rx LPANDACurrent
63187-049Sumatriptan SuccinateSumatriptan SuccinateProficient Rx LPANDACurrent
63187-607Sumatriptan SuccinateSumatriptan SuccinateProficient Rx LPANDACurrent
63187-607Sumatriptan SuccinateSumatriptan SuccinateProficient Rx LPANDACurrent
63187-617Sumatriptan SuccinateSumatriptan SuccinateProficient Rx LPANDACurrent
63187-617Sumatriptan SuccinateSumatriptan SuccinateProficient Rx LPANDACurrent
68071-2283Sumatriptan SuccinateSumatriptan SuccinateNuCare Pharmaceuticals,Inc.ANDACurrent
68071-2283Sumatriptan SuccinateSumatriptan SuccinateNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4562Sumatriptan SuccinateSumatriptan SuccinateNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4562Sumatriptan SuccinateSumatriptan SuccinateNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4562Sumatriptan SuccinateSumatriptan SuccinateNuCare Pharmaceuticals,Inc.ANDACurrent
68788-9004Sumatriptan SuccinateSumatriptan SuccinatePreferred PharmaceuticalsANDACurrent
68788-9005Sumatriptan SuccinateSumatriptan SuccinatePreferred PharmaceuticalsANDACurrent
70518-2859Sumatriptan SuccinateSumatriptan SuccinateREMEDYREPACK INC.ANDACurrent
70518-2859Sumatriptan SuccinateSumatriptan SuccinateREMEDYREPACK INC.ANDACurrent
76420-093Sumatriptan SuccinateSumatriptan SuccinateAsclemed USA, Inc.ANDACurrent