Application 200909

Type
ANDA
Sponsor
DR REDDYS LABS SA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001EZETIMIBE AND SIMVASTATINEZETIMIBE; SIMVASTATINTABLET;ORAL10MG;10MGNoNo
002EZETIMIBE AND SIMVASTATINEZETIMIBE; SIMVASTATINTABLET;ORAL10MG;20MGNoNo
003EZETIMIBE AND SIMVASTATINEZETIMIBE; SIMVASTATINTABLET;ORAL10MG;40MGNoNo
004EZETIMIBE AND SIMVASTATINEZETIMIBE; SIMVASTATINTABLET;ORAL10MG;80MGNoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A200909-001EZETIMIBE AND SIMVASTATINEZETIMIBE; SIMVASTATIN10MG;10MGTABLET / ORALAB2017-04-26
A200909-002EZETIMIBE AND SIMVASTATINEZETIMIBE; SIMVASTATIN10MG;20MGTABLET / ORALAB2017-04-26
A200909-003EZETIMIBE AND SIMVASTATINEZETIMIBE; SIMVASTATIN10MG;40MGTABLET / ORALAB2017-04-26
A200909-004EZETIMIBE AND SIMVASTATINEZETIMIBE; SIMVASTATIN10MG;80MGTABLET / ORALAB2017-04-26

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-productTE code
A200909-001AB
A200909-002AB
A200909-003AB
A200909-004AB

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 5 · 164 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A200909-001EZETIMIBE AND SIMVASTATIN10MG;10MGTABLET / ORALAB2017-04-26011fe1cb6892…
2026-02-19 14:30 UTC2026-02A200909-002EZETIMIBE AND SIMVASTATIN10MG;20MGTABLET / ORALAB2017-04-26011fe1cb6892…
2026-02-19 14:30 UTC2026-02A200909-003EZETIMIBE AND SIMVASTATIN10MG;40MGTABLET / ORALAB2017-04-26011fe1cb6892…
2026-02-19 14:30 UTC2026-02A200909-004EZETIMIBE AND SIMVASTATIN10MG;80MGTABLET / ORALAB2017-04-26011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A200909-001EZETIMIBE AND SIMVASTATIN10MG;10MGTABLET / ORALAB2017-04-2631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A200909-002EZETIMIBE AND SIMVASTATIN10MG;20MGTABLET / ORALAB2017-04-2631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A200909-003EZETIMIBE AND SIMVASTATIN10MG;40MGTABLET / ORALAB2017-04-2631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A200909-004EZETIMIBE AND SIMVASTATIN10MG;80MGTABLET / ORALAB2017-04-2631067a03dcf5…
2025-08-23 18:47 UTC2025-08A200909-001EZETIMIBE AND SIMVASTATIN10MG;10MGTABLET / ORALAB2017-04-266a471c1ec25d…
2025-08-23 18:47 UTC2025-08A200909-002EZETIMIBE AND SIMVASTATIN10MG;20MGTABLET / ORALAB2017-04-266a471c1ec25d…
2025-08-23 18:47 UTC2025-08A200909-003EZETIMIBE AND SIMVASTATIN10MG;40MGTABLET / ORALAB2017-04-266a471c1ec25d…
2025-08-23 18:47 UTC2025-08A200909-004EZETIMIBE AND SIMVASTATIN10MG;80MGTABLET / ORALAB2017-04-266a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A200909-001EZETIMIBE AND SIMVASTATIN10MG;10MGTABLET / ORALAB2017-04-26fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A200909-002EZETIMIBE AND SIMVASTATIN10MG;20MGTABLET / ORALAB2017-04-26fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A200909-003EZETIMIBE AND SIMVASTATIN10MG;40MGTABLET / ORALAB2017-04-26fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A200909-004EZETIMIBE AND SIMVASTATIN10MG;80MGTABLET / ORALAB2017-04-26fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A200909-001EZETIMIBE AND SIMVASTATIN10MG;10MGTABLET / ORALAB2017-04-26b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A200909-002EZETIMIBE AND SIMVASTATIN10MG;20MGTABLET / ORALAB2017-04-26b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A200909-003EZETIMIBE AND SIMVASTATIN10MG;40MGTABLET / ORALAB2017-04-26b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A200909-004EZETIMIBE AND SIMVASTATIN10MG;80MGTABLET / ORALAB2017-04-26b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A200909-001EZETIMIBE AND SIMVASTATIN10MG;10MGTABLET / ORALAB2017-04-2603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A200909-002EZETIMIBE AND SIMVASTATIN10MG;20MGTABLET / ORALAB2017-04-2603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A200909-003EZETIMIBE AND SIMVASTATIN10MG;40MGTABLET / ORALAB2017-04-2603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A200909-004EZETIMIBE AND SIMVASTATIN10MG;80MGTABLET / ORALAB2017-04-2603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A200909-001EZETIMIBE AND SIMVASTATIN10MG;10MGTABLET / ORALAB2017-04-262680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A200909-002EZETIMIBE AND SIMVASTATIN10MG;20MGTABLET / ORALAB2017-04-262680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A200909-003EZETIMIBE AND SIMVASTATIN10MG;40MGTABLET / ORALAB2017-04-262680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A200909-004EZETIMIBE AND SIMVASTATIN10MG;80MGTABLET / ORALAB2017-04-262680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A200909-001EZETIMIBE AND SIMVASTATIN10MG;10MGTABLET / ORALAB2017-04-265bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A200909-002EZETIMIBE AND SIMVASTATIN10MG;20MGTABLET / ORALAB2017-04-265bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A200909-003EZETIMIBE AND SIMVASTATIN10MG;40MGTABLET / ORALAB2017-04-265bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A200909-004EZETIMIBE AND SIMVASTATIN10MG;80MGTABLET / ORALAB2017-04-265bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A200909-001EZETIMIBE AND SIMVASTATIN10MG;10MGTABLET / ORALAB2017-04-26d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A200909-002EZETIMIBE AND SIMVASTATIN10MG;20MGTABLET / ORALAB2017-04-26d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A200909-003EZETIMIBE AND SIMVASTATIN10MG;40MGTABLET / ORALAB2017-04-26d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A200909-004EZETIMIBE AND SIMVASTATIN10MG;80MGTABLET / ORALAB2017-04-26d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A200909-001EZETIMIBE AND SIMVASTATIN10MG;10MGTABLET / ORALAB2017-04-26d06236e962d9…
2024-10-29 15:01 UTC2024-10A200909-002EZETIMIBE AND SIMVASTATIN10MG;20MGTABLET / ORALAB2017-04-26d06236e962d9…
2024-10-29 15:01 UTC2024-10A200909-003EZETIMIBE AND SIMVASTATIN10MG;40MGTABLET / ORALAB2017-04-26d06236e962d9…
2024-10-29 15:01 UTC2024-10A200909-004EZETIMIBE AND SIMVASTATIN10MG;80MGTABLET / ORALAB2017-04-26d06236e962d9…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 164 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A200909-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A200909-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A200909-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A200909-004AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A200909-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A200909-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A200909-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A200909-004AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A200909-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A200909-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A200909-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A200909-004AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A200909-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A200909-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A200909-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A200909-004AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A200909-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A200909-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A200909-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A200909-004AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A200909-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A200909-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A200909-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A200909-004AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A200909-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A200909-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A200909-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A200909-004AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A200909-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A200909-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A200909-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A200909-004AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A200909-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A200909-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A200909-003AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A200909-004AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A200909-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A200909-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A200909-003AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A200909-004AB1d06236e962d9…

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Ezetimibe and SimvastatinEZETIMIBE AND SIMVASTATINGolden State Medical Supply, Inc.88cd0e7b-e8dc-6125-e053-2a95a90aaa272025-11-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 200909
application number: ANDA200909
ndc (product): 51407-191
ndc (product): 51407-193
ndc (product): 51407-192
ndc (product): 51407-190
Ezetimibe and SimvastatinEZETIMIBE AND SIMVASTATINDr.Reddys Laboratories Inc023ca87a-1b04-8c17-dc4f-e2758b0771e22025-07-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 200909
application number: ANDA200909
ndc (product): 43598-745
ndc (product): 43598-743
ndc (product): 43598-744
ndc (product): 43598-742

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 56 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
43598-583Ezetimibe and SimvastatinEzetimibe and SimvastatinDr.Reddys Laboratories IncANDACurrent
43598-583Ezetimibe and SimvastatinEzetimibe and SimvastatinDr.Reddys Laboratories IncANDACurrent
43598-584Ezetimibe and SimvastatinEzetimibe and SimvastatinDr.Reddys Laboratories IncANDACurrent
43598-584Ezetimibe and SimvastatinEzetimibe and SimvastatinDr.Reddys Laboratories IncANDACurrent
43598-585Ezetimibe and SimvastatinEzetimibe and SimvastatinDr.Reddys Laboratories IncANDACurrent
43598-585Ezetimibe and SimvastatinEzetimibe and SimvastatinDr.Reddys Laboratories IncANDACurrent
43598-586Ezetimibe and SimvastatinEzetimibe and SimvastatinDr.Reddys Laboratories IncANDACurrent
43598-586Ezetimibe and SimvastatinEzetimibe and SimvastatinDr.Reddys Laboratories IncANDACurrent
43598-742Ezetimibe and SimvastatinEzetimibe and SimvastatinDr.Reddys Laboratories IncANDACurrent
43598-742Ezetimibe and SimvastatinEzetimibe and SimvastatinDr.Reddys Laboratories IncANDACurrent
43598-742Ezetimibe and SimvastatinEzetimibe and SimvastatinDr.Reddys Laboratories IncANDACurrent
43598-743Ezetimibe and SimvastatinEzetimibe and SimvastatinDr.Reddys Laboratories IncANDACurrent
43598-743Ezetimibe and SimvastatinEzetimibe and SimvastatinDr.Reddys Laboratories IncANDACurrent
43598-743Ezetimibe and SimvastatinEzetimibe and SimvastatinDr.Reddys Laboratories IncANDACurrent
43598-744Ezetimibe and SimvastatinEzetimibe and SimvastatinDr.Reddys Laboratories IncANDACurrent
43598-744Ezetimibe and SimvastatinEzetimibe and SimvastatinDr.Reddys Laboratories IncANDACurrent
43598-744Ezetimibe and SimvastatinEzetimibe and SimvastatinDr.Reddys Laboratories IncANDACurrent
43598-745Ezetimibe and SimvastatinEzetimibe and SimvastatinDr.Reddys Laboratories IncANDACurrent
43598-745Ezetimibe and SimvastatinEzetimibe and SimvastatinDr.Reddys Laboratories IncANDACurrent
43598-745Ezetimibe and SimvastatinEzetimibe and SimvastatinDr.Reddys Laboratories IncANDACurrent
51407-190Ezetimibe and SimvastatinEzetimibe and SimvastatinGolden State Medical Supply Inc.ANDACurrent
51407-190Ezetimibe and SimvastatinEzetimibe and SimvastatinGolden State Medical Supply Inc.ANDACurrent
51407-190Ezetimibe and SimvastatinEzetimibe and SimvastatinGolden State Medical Supply Inc.ANDACurrent
51407-190Ezetimibe and SimvastatinEzetimibe and SimvastatinGolden State Medical SupplyANDACurrent
51407-190Ezetimibe and SimvastatinEzetimibe and SimvastatinGolden State Medical SupplyANDACurrent
51407-191Ezetimibe and SimvastatinEzetimibe and SimvastatinGolden State Medical Supply Inc.ANDACurrent
51407-191Ezetimibe and SimvastatinEzetimibe and SimvastatinGolden State Medical Supply Inc.ANDACurrent
51407-191Ezetimibe and SimvastatinEzetimibe and SimvastatinGolden State Medical Supply Inc.ANDACurrent
51407-191Ezetimibe and SimvastatinEzetimibe and SimvastatinGolden State Medical SupplyANDACurrent
51407-191Ezetimibe and SimvastatinEzetimibe and SimvastatinGolden State Medical SupplyANDACurrent
51407-192Ezetimibe and SimvastatinEzetimibe and SimvastatinGolden State Medical Supply Inc.ANDACurrent
51407-192Ezetimibe and SimvastatinEzetimibe and SimvastatinGolden State Medical Supply Inc.ANDACurrent
51407-192Ezetimibe and SimvastatinEzetimibe and SimvastatinGolden State Medical Supply Inc.ANDACurrent
51407-192Ezetimibe and SimvastatinEzetimibe and SimvastatinGolden State Medical SupplyANDACurrent
51407-192Ezetimibe and SimvastatinEzetimibe and SimvastatinGolden State Medical SupplyANDACurrent
51407-193Ezetimibe and SimvastatinEzetimibe and SimvastatinGolden State Medical Supply Inc.ANDACurrent
51407-193Ezetimibe and SimvastatinEzetimibe and SimvastatinGolden State Medical Supply Inc.ANDACurrent
51407-193Ezetimibe and SimvastatinEzetimibe and SimvastatinGolden State Medical Supply Inc.ANDACurrent
51407-193Ezetimibe and SimvastatinEzetimibe and SimvastatinGolden State Medical SupplyANDACurrent
51407-193Ezetimibe and SimvastatinEzetimibe and SimvastatinGolden State Medical SupplyANDACurrent
60429-879Ezetimibe and SimvastatinEzetimibe and SimvastatinGolden State Medical Supply, Inc.ANDACurrent
60429-879Ezetimibe and SimvastatinEzetimibe and SimvastatinGolden State Medical Supply, Inc.ANDACurrent
60429-879Ezetimibe and SimvastatinEzetimibe and SimvastatinGolden State Medical Supply, Inc.ANDACurrent
60429-880Ezetimibe and SimvastatinEzetimibe and SimvastatinGolden State Medical Supply, Inc.ANDACurrent
60429-880Ezetimibe and SimvastatinEzetimibe and SimvastatinGolden State Medical Supply, Inc.ANDACurrent
60429-880Ezetimibe and SimvastatinEzetimibe and SimvastatinGolden State Medical Supply, Inc.ANDACurrent
60429-880Ezetimibe and SimvastatinEzetimibe and SimvastatinGolden State Medical Supply, Inc.ANDACurrent
60429-880Ezetimibe and SimvastatinEzetimibe and SimvastatinGolden State Medical Supply, Inc.ANDACurrent
60429-881Ezetimibe and SimvastatinEzetimibe and SimvastatinGolden State Medical Supply, Inc.ANDACurrent
60429-881Ezetimibe and SimvastatinEzetimibe and SimvastatinGolden State Medical Supply, Inc.ANDACurrent
60429-881Ezetimibe and SimvastatinEzetimibe and SimvastatinGolden State Medical Supply, Inc.ANDACurrent
60429-881Ezetimibe and SimvastatinEzetimibe and SimvastatinGolden State Medical Supply, Inc.ANDACurrent
60429-881Ezetimibe and SimvastatinEzetimibe and SimvastatinGolden State Medical Supply, Inc.ANDACurrent
60429-882Ezetimibe and SimvastatinEzetimibe and SimvastatinGolden State Medical Supply, Inc.ANDACurrent
60429-882Ezetimibe and SimvastatinEzetimibe and SimvastatinGolden State Medical Supply, Inc.ANDACurrent
60429-882Ezetimibe and SimvastatinEzetimibe and SimvastatinGolden State Medical Supply, Inc.ANDACurrent