Application 201619

Type
ANDA
Sponsor
TORRENT

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
A201619-001ROSUVASTATIN CALCIUMROSUVASTATIN CALCIUMEQ 5MG BASETABLET / ORALAB2016-10-31
A201619-002ROSUVASTATIN CALCIUMROSUVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2016-10-31
A201619-003ROSUVASTATIN CALCIUMROSUVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2016-10-31
A201619-004ROSUVASTATIN 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
A201619-001AB
A201619-002AB
A201619-003AB
A201619-004AB

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 06:07:402026-07A201619-001ROSUVASTATIN CALCIUMEQ 5MG BASETABLET / ORALAB2016-10-31caaa826d4ba7…
2026-08-18 06:07:402026-07A201619-002ROSUVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2016-10-31caaa826d4ba7…
2026-08-18 06:07:402026-07A201619-003ROSUVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2016-10-31caaa826d4ba7…
2026-08-18 06:07:402026-07A201619-004ROSUVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2016-10-31caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A201619-001ROSUVASTATIN CALCIUMEQ 5MG BASETABLET / ORALAB2016-10-31011fe1cb6892…
2026-02-19 14:30 UTC2026-02A201619-002ROSUVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2016-10-31011fe1cb6892…
2026-02-19 14:30 UTC2026-02A201619-003ROSUVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2016-10-31011fe1cb6892…
2026-02-19 14:30 UTC2026-02A201619-004ROSUVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2016-10-31011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A201619-001ROSUVASTATIN CALCIUMEQ 5MG BASETABLET / ORALAB2016-10-3131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A201619-002ROSUVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2016-10-3131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A201619-003ROSUVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2016-10-3131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A201619-004ROSUVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2016-10-3131067a03dcf5…
2025-08-23 18:47 UTC2025-08A201619-001ROSUVASTATIN CALCIUMEQ 5MG BASETABLET / ORALAB2016-10-316a471c1ec25d…
2025-08-23 18:47 UTC2025-08A201619-002ROSUVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2016-10-316a471c1ec25d…
2025-08-23 18:47 UTC2025-08A201619-003ROSUVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2016-10-316a471c1ec25d…
2025-08-23 18:47 UTC2025-08A201619-004ROSUVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2016-10-316a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A201619-001ROSUVASTATIN CALCIUMEQ 5MG BASETABLET / ORALAB2016-10-31fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A201619-002ROSUVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2016-10-31fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A201619-003ROSUVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2016-10-31fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A201619-004ROSUVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2016-10-31fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A201619-001ROSUVASTATIN CALCIUMEQ 5MG BASETABLET / ORALAB2016-10-31b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A201619-002ROSUVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2016-10-31b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A201619-003ROSUVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2016-10-31b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A201619-004ROSUVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2016-10-31b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A201619-001ROSUVASTATIN CALCIUMEQ 5MG BASETABLET / ORALAB2016-10-3103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A201619-002ROSUVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2016-10-3103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A201619-003ROSUVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2016-10-3103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A201619-004ROSUVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2016-10-3103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A201619-001ROSUVASTATIN CALCIUMEQ 5MG BASETABLET / ORALAB2016-10-312680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A201619-002ROSUVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2016-10-312680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A201619-003ROSUVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2016-10-312680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A201619-004ROSUVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2016-10-312680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A201619-001ROSUVASTATIN CALCIUMEQ 5MG BASETABLET / ORALAB2016-10-315bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A201619-002ROSUVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2016-10-315bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A201619-003ROSUVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2016-10-315bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A201619-004ROSUVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2016-10-315bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A201619-001ROSUVASTATIN CALCIUMEQ 5MG BASETABLET / ORALAB2016-10-31d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A201619-002ROSUVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2016-10-31d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A201619-003ROSUVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2016-10-31d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A201619-004ROSUVASTATIN 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 06:07:402026-07A201619-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A201619-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A201619-003AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A201619-004AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A201619-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A201619-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A201619-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A201619-004AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A201619-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A201619-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A201619-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A201619-004AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A201619-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A201619-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A201619-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A201619-004AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A201619-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A201619-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A201619-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A201619-004AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A201619-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A201619-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A201619-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A201619-004AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A201619-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A201619-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A201619-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A201619-004AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A201619-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A201619-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A201619-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A201619-004AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A201619-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A201619-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A201619-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A201619-004AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A201619-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A201619-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A201619-003AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A201619-004AB1d8e5a09893c0…

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 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Rosuvastatin CalciumROSUVASTATIN CALCIUMTorrent Pharmaceuticals Limited8c2d481f-53f2-4cf6-bd28-7d92323785cd2026-06-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201619
application number: ANDA201619
ndc (product): 13668-179
ndc (product): 13668-180
ndc (product): 13668-181
ndc (product): 13668-182
Rosuvastatin CalciumROSUVASTATIN CALCIUMNorthwind Health Company, LLCda6bfffb-7b04-b522-e053-2a95a90a47362026-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201619
application number: ANDA201619
Rosuvastatin CalciumROSUVASTATIN CALCIUMBryant Ranch Prepack1c97c9da-687b-47c1-9b9e-61f9a37bb9c42024-10-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201619
application number: ANDA201619
ndc (product): 63629-7158

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 66 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0904-6778Rosuvastatin CalciumRosuvastatin CalciumMajor PharmaceuticalsANDACurrent
0904-6778Rosuvastatin CalciumRosuvastatin CalciumMajor PharmaceuticalsANDACurrent
0904-6778Rosuvastatin CalciumRosuvastatin CalciumMajor PharmaceuticalsANDACurrent
0904-6778Rosuvastatin CalciumRosuvastatin CalciumMajor PharmaceuticalsANDACurrent
0904-6779Rosuvastatin CalciumRosuvastatin CalciumMajor PharmaceuticalsANDACurrent
0904-6779Rosuvastatin CalciumRosuvastatin CalciumMajor PharmaceuticalsANDACurrent
0904-6779Rosuvastatin CalciumRosuvastatin CalciumMajor PharmaceuticalsANDACurrent
0904-6779Rosuvastatin CalciumRosuvastatin CalciumMajor PharmaceuticalsANDACurrent
0904-6780Rosuvastatin CalciumRosuvastatin CalciumMajor PharmaceuticalsANDACurrent
0904-6780Rosuvastatin CalciumRosuvastatin CalciumMajor PharmaceuticalsANDACurrent
0904-6780Rosuvastatin CalciumRosuvastatin CalciumMajor PharmaceuticalsANDACurrent
0904-6780Rosuvastatin CalciumRosuvastatin CalciumMajor PharmaceuticalsANDACurrent
0904-6781Rosuvastatin CalciumRosuvastatin CalciumMajor PharmaceuticalsANDACurrent
0904-6781Rosuvastatin CalciumRosuvastatin CalciumMajor PharmaceuticalsANDACurrent
0904-6781Rosuvastatin CalciumRosuvastatin CalciumMajor PharmaceuticalsANDACurrent
0904-6781Rosuvastatin CalciumRosuvastatin CalciumMajor PharmaceuticalsANDACurrent
13668-179Rosuvastatin CalciumRosuvastatin CalciumTorrent Pharmaceuticals LimitedANDACurrent
13668-179Rosuvastatin CalciumRosuvastatin CalciumTorrent Pharmaceuticals LimitedANDACurrent
13668-179Rosuvastatin CalciumRosuvastatin CalciumTorrent Pharmaceuticals LimitedANDACurrent
13668-179Rosuvastatin CalciumRosuvastatin CalciumTorrent Pharmaceuticals LimitedANDACurrent
13668-179Rosuvastatin CalciumRosuvastatin CalciumTorrent Pharmaceuticals LimitedANDACurrent
13668-179Rosuvastatin CalciumRosuvastatin CalciumTorrent Pharmaceuticals LimitedANDACurrent
13668-179Rosuvastatin CalciumRosuvastatin CalciumTorrent Pharmaceuticals LimitedANDACurrent
13668-179Rosuvastatin CalciumRosuvastatin CalciumTorrent Pharmaceuticals LimitedANDACurrent
13668-180Rosuvastatin CalciumRosuvastatin CalciumTorrent Pharmaceuticals LimitedANDACurrent
13668-180Rosuvastatin CalciumRosuvastatin CalciumTorrent Pharmaceuticals LimitedANDACurrent
13668-180Rosuvastatin CalciumRosuvastatin CalciumTorrent Pharmaceuticals LimitedANDACurrent
13668-180Rosuvastatin CalciumRosuvastatin CalciumTorrent Pharmaceuticals LimitedANDACurrent
13668-180Rosuvastatin CalciumRosuvastatin CalciumTorrent Pharmaceuticals LimitedANDACurrent
13668-180Rosuvastatin CalciumRosuvastatin CalciumTorrent Pharmaceuticals LimitedANDACurrent
13668-180Rosuvastatin CalciumRosuvastatin CalciumTorrent Pharmaceuticals LimitedANDACurrent
13668-180Rosuvastatin CalciumRosuvastatin CalciumTorrent Pharmaceuticals LimitedANDACurrent
13668-181Rosuvastatin CalciumRosuvastatin CalciumTorrent Pharmaceuticals LimitedANDACurrent
13668-181Rosuvastatin CalciumRosuvastatin CalciumTorrent Pharmaceuticals LimitedANDACurrent
13668-181Rosuvastatin CalciumRosuvastatin CalciumTorrent Pharmaceuticals LimitedANDACurrent
13668-181Rosuvastatin CalciumRosuvastatin CalciumTorrent Pharmaceuticals LimitedANDACurrent
13668-181Rosuvastatin CalciumRosuvastatin CalciumTorrent Pharmaceuticals LimitedANDACurrent
13668-181Rosuvastatin CalciumRosuvastatin CalciumTorrent Pharmaceuticals LimitedANDACurrent
13668-181Rosuvastatin CalciumRosuvastatin CalciumTorrent Pharmaceuticals LimitedANDACurrent
13668-181Rosuvastatin CalciumRosuvastatin CalciumTorrent Pharmaceuticals LimitedANDACurrent
13668-182Rosuvastatin CalciumRosuvastatin CalciumTorrent Pharmaceuticals LimitedANDACurrent
13668-182Rosuvastatin CalciumRosuvastatin CalciumTorrent Pharmaceuticals LimitedANDACurrent
13668-182Rosuvastatin CalciumRosuvastatin CalciumTorrent Pharmaceuticals LimitedANDACurrent
13668-182Rosuvastatin CalciumRosuvastatin CalciumTorrent Pharmaceuticals LimitedANDACurrent
13668-182Rosuvastatin CalciumRosuvastatin CalciumTorrent Pharmaceuticals LimitedANDACurrent
13668-182Rosuvastatin CalciumRosuvastatin CalciumTorrent Pharmaceuticals LimitedANDACurrent
13668-182Rosuvastatin CalciumRosuvastatin CalciumTorrent Pharmaceuticals LimitedANDACurrent
13668-182Rosuvastatin CalciumRosuvastatin CalciumTorrent Pharmaceuticals LimitedANDACurrent
50090-4039Rosuvastatin CalciumRosuvastatin CalciumA-S Medication SolutionsANDACurrent
50090-4039Rosuvastatin CalciumRosuvastatin CalciumA-S Medication SolutionsANDACurrent
50090-4056Rosuvastatin CalciumRosuvastatin CalciumA-S Medication SolutionsANDACurrent
50090-4056Rosuvastatin CalciumRosuvastatin CalciumA-S Medication SolutionsANDACurrent
50090-5116Rosuvastatin CalciumRosuvastatin CalciumA-S Medication SolutionsANDACurrent
50090-5116Rosuvastatin CalciumRosuvastatin CalciumA-S Medication SolutionsANDACurrent
55154-8099Rosuvastatin CalciumRosuvastatin CalciumCardinal Health 107, LLCANDACurrent
55154-8099Rosuvastatin CalciumRosuvastatin CalciumCardinal HealthANDACurrent
55154-8099Rosuvastatin CalciumRosuvastatin CalciumCardinal HealthANDACurrent
55154-8099Rosuvastatin CalciumRosuvastatin CalciumCardinal HealthANDACurrent
63629-7158Rosuvastatin CalciumRosuvastatin CalciumBryant Ranch PrepackANDACurrent
63629-7158Rosuvastatin CalciumRosuvastatin CalciumBryant Ranch PrepackANDACurrent
63629-7158Rosuvastatin CalciumRosuvastatin CalciumBryant Ranch PrepackANDACurrent
63629-7158Rosuvastatin CalciumRosuvastatin CalciumBryant Ranch PrepackANDACurrent
68071-3348Rosuvastatin CalciumRosuvastatin CalciumNuCare Pharmaceuticals,Inc.ANDACurrent
68071-3348Rosuvastatin CalciumRosuvastatin CalciumNuCare Pharmaceuticals,Inc.ANDACurrent
68071-3348Rosuvastatin CalciumRosuvastatin CalciumNuCare Pharmaceuticals,Inc.ANDACurrent
68071-3349Rosuvastatin CalciumRosuvastatin CalciumNuCare Pharmaceuticals,Inc.ANDACurrent