Application 207752

Type
ANDA
Sponsor
BIOCON LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ROSUVASTATIN CALCIUMROSUVASTATIN CALCIUMTABLET;ORAL5MGNoNo
002ROSUVASTATIN CALCIUMROSUVASTATIN CALCIUMTABLET;ORAL10MGNoNo
003ROSUVASTATIN CALCIUMROSUVASTATIN CALCIUMTABLET;ORAL20MGNoNo
004ROSUVASTATIN CALCIUMROSUVASTATIN CALCIUMTABLET;ORAL40MGNoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A207752-001ROSUVASTATIN CALCIUMROSUVASTATIN CALCIUMEQ 5MG BASETABLET / ORALAB2016-10-31
A207752-002ROSUVASTATIN CALCIUMROSUVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2016-10-31
A207752-003ROSUVASTATIN CALCIUMROSUVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2016-10-31
A207752-004ROSUVASTATIN CALCIUMROSUVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2016-10-31

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A207752-001AB
A207752-002AB
A207752-003AB
A207752-004AB

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 · 168 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A207752-001ROSUVASTATIN CALCIUMEQ 5MG BASETABLET / ORALAB2016-10-31caaa826d4ba7…
2026-08-18 06:07:402026-07A207752-002ROSUVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2016-10-31caaa826d4ba7…
2026-08-18 06:07:402026-07A207752-003ROSUVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2016-10-31caaa826d4ba7…
2026-08-18 06:07:402026-07A207752-004ROSUVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2016-10-31caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A207752-001ROSUVASTATIN CALCIUMEQ 5MG BASETABLET / ORALAB2016-10-31011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207752-002ROSUVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2016-10-31011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207752-003ROSUVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2016-10-31011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207752-004ROSUVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2016-10-31011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207752-001ROSUVASTATIN CALCIUMEQ 5MG BASETABLET / ORALAB2016-10-3131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207752-002ROSUVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2016-10-3131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207752-003ROSUVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2016-10-3131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207752-004ROSUVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2016-10-3131067a03dcf5…
2025-08-23 18:47 UTC2025-08A207752-001ROSUVASTATIN CALCIUMEQ 5MG BASETABLET / ORALAB2016-10-316a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207752-002ROSUVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2016-10-316a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207752-003ROSUVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2016-10-316a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207752-004ROSUVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2016-10-316a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207752-001ROSUVASTATIN CALCIUMEQ 5MG BASETABLET / ORALAB2016-10-31fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207752-002ROSUVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2016-10-31fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207752-003ROSUVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2016-10-31fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207752-004ROSUVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2016-10-31fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207752-001ROSUVASTATIN CALCIUMEQ 5MG BASETABLET / ORALAB2016-10-31b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207752-002ROSUVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2016-10-31b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207752-003ROSUVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2016-10-31b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207752-004ROSUVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2016-10-31b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207752-001ROSUVASTATIN CALCIUMEQ 5MG BASETABLET / ORALAB2016-10-3103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207752-002ROSUVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2016-10-3103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207752-003ROSUVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2016-10-3103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207752-004ROSUVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2016-10-3103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207752-001ROSUVASTATIN CALCIUMEQ 5MG BASETABLET / ORALAB2016-10-312680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207752-002ROSUVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2016-10-312680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207752-003ROSUVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2016-10-312680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207752-004ROSUVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2016-10-312680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207752-001ROSUVASTATIN CALCIUMEQ 5MG BASETABLET / ORALAB2016-10-315bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207752-002ROSUVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2016-10-315bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207752-003ROSUVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2016-10-315bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207752-004ROSUVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2016-10-315bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207752-001ROSUVASTATIN CALCIUMEQ 5MG BASETABLET / ORALAB2016-10-31d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207752-002ROSUVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2016-10-31d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207752-003ROSUVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2016-10-31d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207752-004ROSUVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2016-10-31d8e5a09893c0…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 168 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A207752-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A207752-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A207752-003AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A207752-004AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A207752-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207752-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207752-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207752-004AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207752-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207752-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207752-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207752-004AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A207752-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207752-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207752-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207752-004AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207752-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207752-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207752-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207752-004AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207752-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207752-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207752-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207752-004AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207752-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207752-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207752-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207752-004AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207752-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207752-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207752-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207752-004AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207752-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207752-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207752-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207752-004AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207752-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207752-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207752-003AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207752-004AB1d8e5a09893c0…

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 · 12 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Rosuvastatin calciumROSUVASTATIN CALCIUMBiocon Pharma Inc033d8c8f-bbe9-96b5-fd53-cb0ef929857a2025-05-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207752
application number: ANDA207752
ndc (product): 70377-007
ndc (product): 70377-008
ndc (product): 70377-006
ndc (product): 70377-009
ROSUVASTATIN CALCIUMROSUVASTATIN CALCIUMPURACAP LABORATORIES LLC DBA BLU PHARMACEUTICALS9333c674-5714-41ed-8a16-dc7c3e50b9a42025-01-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207752
application number: ANDA207752
Rosuvastatin calciumROSUVASTATIN CALCIUMBryant Ranch Prepack51d0ef20-c80d-44de-ac85-9b73608dba0b2024-08-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207752
application number: ANDA207752
ndc (product): 71335-1890
ROSUVASTATIN CALCIUMROSUVASTATIN CALCIUMAphena Pharma Solutions - Tennessee, LLC128d52ea-abad-c8ef-e063-6394a90a3fec2024-02-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207752
application number: ANDA207752
ROSUVASTATIN CALCIUMROSUVASTATIN CALCIUMAphena Pharma Solutions - Tennessee, LLC113160c7-7b41-5395-e063-6394a90a1e152024-02-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207752
application number: ANDA207752
Rosuvastatin calciumROSUVASTATIN CALCIUMBryant Ranch Prepackeeb492b0-32d8-489e-ab60-6eec52a28efd2023-11-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207752
application number: ANDA207752
ndc (product): 71335-1741
Rosuvastatin calciumROSUVASTATIN CALCIUMBryant Ranch Prepacke41da8b8-db23-49e1-9ee0-55423d2859802023-11-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207752
application number: ANDA207752
ndc (product): 71335-1889
Rosuvastatin calciumROSUVASTATIN CALCIUMBryant Ranch Prepack88ab1c85-e864-4879-8489-8365ded78bb52023-11-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207752
application number: ANDA207752
ndc (product): 71335-1939
Rosuvastatin calciumROSUVASTATIN CALCIUMA-S Medication Solutions9b8f614f-d49c-464b-b580-5fb9f2c256812023-09-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207752
application number: ANDA207752
ndc (product): 50090-5970
Rosuvastatin calciumROSUVASTATIN CALCIUMA-S Medication Solutions5f392edb-f7fc-40b4-8446-35494e83a69e2023-06-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207752
application number: ANDA207752
Rosuvastatin calciumROSUVASTATIN CALCIUMProficient Rx LPd1bd91fd-03fa-4e6c-80c1-ce58b158d8d62022-11-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207752
application number: ANDA207752
ndc (product): 71205-052
Rosuvastatin calciumROSUVASTATIN CALCIUMAphena Pharma Solutions - Tennessee, LLCcbef0681-705c-48fd-add9-1042658ef85d2018-09-12Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207752
application number: ANDA207752
ndc (product): 71610-133

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 35 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
50090-5970Rosuvastatin calciumRosuvastatin CalciumA-S Medication SolutionsANDACurrent
70377-006Rosuvastatin calciumRosuvastatin CalciumBiocon Pharma IncANDACurrent
70377-006Rosuvastatin calciumRosuvastatin CalciumBiocon Pharma IncANDACurrent
70377-006Rosuvastatin CalciumRosuvastatin CalciumBiocon Pharma IncANDACurrent
70377-006Rosuvastatin calciumRosuvastatin CalciumBiocon Pharma IncANDACurrent
70377-006Rosuvastatin calciumRosuvastatin CalciumBiocon Pharma IncANDACurrent
70377-007Rosuvastatin calciumRosuvastatin CalciumBiocon Pharma IncANDACurrent
70377-007Rosuvastatin calciumRosuvastatin CalciumBiocon Pharma IncANDACurrent
70377-007Rosuvastatin calciumRosuvastatin CalciumBiocon Pharma IncANDACurrent
70377-007Rosuvastatin calciumRosuvastatin CalciumBiocon Pharma IncANDACurrent
70377-007Rosuvastatin calciumRosuvastatin CalciumBiocon Pharma IncANDACurrent
70377-008Rosuvastatin calciumRosuvastatin CalciumBiocon Pharma IncANDACurrent
70377-008Rosuvastatin calciumRosuvastatin CalciumBiocon Pharma IncANDACurrent
70377-008Rosuvastatin calciumRosuvastatin CalciumBiocon Pharma IncANDACurrent
70377-008Rosuvastatin calciumRosuvastatin CalciumBiocon Pharma IncANDACurrent
70377-008Rosuvastatin calciumRosuvastatin CalciumBiocon Pharma IncANDACurrent
70377-009Rosuvastatin calciumRosuvastatin CalciumBiocon Pharma IncANDACurrent
70377-009Rosuvastatin calciumRosuvastatin CalciumBiocon Pharma IncANDACurrent
70377-009Rosuvastatin calciumRosuvastatin CalciumBiocon Pharma IncANDACurrent
70377-009Rosuvastatin calciumRosuvastatin CalciumBiocon Pharma IncANDACurrent
70377-009Rosuvastatin calciumRosuvastatin CalciumBiocon Pharma IncANDACurrent
70518-1745Rosuvastatin calciumRosuvastatin CalciumREMEDYREPACK INC.ANDACurrent
70518-1745Rosuvastatin calciumRosuvastatin CalciumREMEDYREPACK INC.ANDACurrent
71205-052Rosuvastatin calciumRosuvastatin CalciumProficient Rx LPANDACurrent
71205-052Rosuvastatin calciumRosuvastatin CalciumProficient Rx LPANDACurrent
71205-052Rosuvastatin calciumRosuvastatin CalciumProficient Rx LPANDACurrent
71335-1741Rosuvastatin calciumRosuvastatin CalciumBryant Ranch PrepackANDACurrent
71335-1741Rosuvastatin calciumRosuvastatin CalciumBryant Ranch PrepackANDACurrent
71335-1889Rosuvastatin calciumRosuvastatin CalciumBryant Ranch PrepackANDACurrent
71335-1889Rosuvastatin calciumRosuvastatin CalciumBryant Ranch PrepackANDACurrent
71335-1890Rosuvastatin calciumRosuvastatin CalciumBryant Ranch PrepackANDACurrent
71335-1890Rosuvastatin calciumRosuvastatin CalciumBryant Ranch PrepackANDACurrent
71335-1939Rosuvastatin calciumRosuvastatin CalciumBryant Ranch PrepackANDACurrent
71335-1939Rosuvastatin calciumRosuvastatin CalciumBryant Ranch PrepackANDACurrent
71610-133Rosuvastatin calciumRosuvastatin CalciumAphena Pharma Solutions - Tennessee, LLCANDACurrent