Application 207616

Type
ANDA
Sponsor
HETERO LABS LTD V

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
A207616-001ROSUVASTATIN CALCIUMROSUVASTATIN CALCIUMEQ 5MG BASETABLET / ORALAB2016-10-31
A207616-002ROSUVASTATIN CALCIUMROSUVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2016-10-31
A207616-003ROSUVASTATIN CALCIUMROSUVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2016-10-31
A207616-004ROSUVASTATIN 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
A207616-001AB
A207616-002AB
A207616-003AB
A207616-004AB

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 06:07:402026-07A207616-001ROSUVASTATIN CALCIUMEQ 5MG BASETABLET / ORALAB2016-10-31caaa826d4ba7…
2026-08-18 06:07:402026-07A207616-002ROSUVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2016-10-31caaa826d4ba7…
2026-08-18 06:07:402026-07A207616-003ROSUVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2016-10-31caaa826d4ba7…
2026-08-18 06:07:402026-07A207616-004ROSUVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2016-10-31caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A207616-001ROSUVASTATIN CALCIUMEQ 5MG BASETABLET / ORALAB2016-10-31011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207616-002ROSUVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2016-10-31011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207616-003ROSUVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2016-10-31011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207616-004ROSUVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2016-10-31011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207616-001ROSUVASTATIN CALCIUMEQ 5MG BASETABLET / ORALAB2016-10-3131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207616-002ROSUVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2016-10-3131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207616-003ROSUVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2016-10-3131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207616-004ROSUVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2016-10-3131067a03dcf5…
2025-08-23 18:47 UTC2025-08A207616-001ROSUVASTATIN CALCIUMEQ 5MG BASETABLET / ORALAB2016-10-316a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207616-002ROSUVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2016-10-316a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207616-003ROSUVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2016-10-316a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207616-004ROSUVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2016-10-316a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207616-001ROSUVASTATIN CALCIUMEQ 5MG BASETABLET / ORALAB2016-10-31fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207616-002ROSUVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2016-10-31fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207616-003ROSUVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2016-10-31fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207616-004ROSUVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2016-10-31fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207616-001ROSUVASTATIN CALCIUMEQ 5MG BASETABLET / ORALAB2016-10-31b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207616-002ROSUVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2016-10-31b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207616-003ROSUVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2016-10-31b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207616-004ROSUVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2016-10-31b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207616-001ROSUVASTATIN CALCIUMEQ 5MG BASETABLET / ORALAB2016-10-3103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207616-002ROSUVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2016-10-3103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207616-003ROSUVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2016-10-3103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207616-004ROSUVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2016-10-3103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207616-001ROSUVASTATIN CALCIUMEQ 5MG BASETABLET / ORALAB2016-10-312680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207616-002ROSUVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2016-10-312680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207616-003ROSUVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2016-10-312680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207616-004ROSUVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2016-10-312680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207616-001ROSUVASTATIN CALCIUMEQ 5MG BASETABLET / ORALAB2016-10-315bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207616-002ROSUVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2016-10-315bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207616-003ROSUVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2016-10-315bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207616-004ROSUVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2016-10-315bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207616-001ROSUVASTATIN CALCIUMEQ 5MG BASETABLET / ORALAB2016-10-31d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207616-002ROSUVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2016-10-31d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207616-003ROSUVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2016-10-31d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207616-004ROSUVASTATIN 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 06:07:402026-07A207616-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A207616-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A207616-003AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A207616-004AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A207616-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207616-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207616-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207616-004AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207616-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207616-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207616-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207616-004AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A207616-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207616-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207616-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207616-004AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207616-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207616-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207616-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207616-004AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207616-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207616-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207616-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207616-004AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207616-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207616-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207616-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207616-004AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207616-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207616-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207616-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207616-004AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207616-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207616-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207616-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207616-004AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207616-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207616-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207616-003AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207616-004AB1d8e5a09893c0…

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 · 7 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
RosuvastatinROSUVASTATINCamber Pharmaceuticals, Inc.7778df5a-82c1-4a86-8867-a3325da025ec2026-06-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207616
application number: ANDA207616
ndc (product): 31722-883
ndc (product): 31722-884
ndc (product): 31722-882
ndc (product): 31722-885
RosuvastatinROSUVASTATINCardinal Health 107, LLC0f7fad2c-fc46-4ebc-b55b-6534da99e0532026-06-12Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207616
application number: ANDA207616
RosuvastatinROSUVASTATINBryant Ranch Prepacke6b86b67-62c7-43cc-8174-b2b8e0a607112026-04-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207616
application number: ANDA207616
RosuvastatinROSUVASTATINPreferred Pharmaceuticals Inc.979588e5-d266-4728-aa58-36cd6a2175842025-09-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207616
application number: ANDA207616
RosuvastatinROSUVASTATINPreferred Pharmaceuticals Inc.92a58577-b549-4143-abd0-391a07ed714d2025-09-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207616
application number: ANDA207616
RosuvastatinROSUVASTATINAvPAK7cd6ae8d-aa67-60db-e053-2991aa0a0ede2025-07-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207616
application number: ANDA207616
ndc (product): 50268-709
ndc (product): 50268-710
ndc (product): 50268-711
RosuvastatinROSUVASTATINProficient Rx LPf42139aa-bb38-4791-b41e-cd8f2c9225292025-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207616
application number: ANDA207616
ndc (product): 71205-044

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 64 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
31722-882RosuvastatinRosuvastatinCamber Pharmaceuticals, Inc.ANDACurrent
31722-882RosuvastatinRosuvastatinCamber Pharmaceuticals, Inc.ANDACurrent
31722-883RosuvastatinRosuvastatinCamber Pharmaceuticals, Inc.ANDACurrent
31722-883RosuvastatinRosuvastatinCamber Pharmaceuticals, Inc.ANDACurrent
31722-884RosuvastatinRosuvastatinCamber Pharmaceuticals, Inc.ANDACurrent
31722-884RosuvastatinRosuvastatinCamber Pharmaceuticals, Inc.ANDACurrent
31722-885RosuvastatinRosuvastatinCamber Pharmaceuticals, Inc.ANDACurrent
31722-885RosuvastatinRosuvastatinCamber Pharmaceuticals, Inc.ANDACurrent
50090-2722RosuvastatinRosuvastatinA-S Medication SolutionsANDACurrent
50090-2723RosuvastatinRosuvastatinA-S Medication SolutionsANDACurrent
50090-2724RosuvastatinRosuvastatinA-S Medication SolutionsANDACurrent
50090-2724RosuvastatinRosuvastatinA-S Medication SolutionsANDACurrent
50090-2724RosuvastatinRosuvastatinA-S Medication SolutionsANDACurrent
50090-2725RosuvastatinRosuvastatinA-S Medication SolutionsANDACurrent
50090-2725RosuvastatinRosuvastatinA-S Medication SolutionsANDACurrent
50090-2725RosuvastatinRosuvastatinA-S Medication SolutionsANDACurrent
50090-2725RosuvastatinRosuvastatinA-S Medication SolutionsANDACurrent
50090-2725RosuvastatinRosuvastatinA-S Medication SolutionsANDACurrent
50090-4909RosuvastatinRosuvastatinA-S Medication SolutionsANDACurrent
50268-709RosuvastatinRosuvastatinAvPAKANDACurrent
50268-709RosuvastatinRosuvastatinAvPAKANDACurrent
50268-710RosuvastatinRosuvastatinAvPAKANDACurrent
50268-710RosuvastatinRosuvastatinAvPAKANDACurrent
50268-711RosuvastatinRosuvastatinAvPAKANDACurrent
50268-711RosuvastatinRosuvastatinAvPAKANDACurrent
55700-574RosuvastatinRosuvastatinLake Erie Medical DBA QuaANDACurrent
55700-574RosuvastatinRosuvastatinLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-574RosuvastatinRosuvastatinLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-575RosuvastatinRosuvastatinLake Erie Medical DBA QuaANDACurrent
55700-575RosuvastatinRosuvastatinQuality Care Products, LLCANDACurrent
55700-575RosuvastatinRosuvastatinLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-575RosuvastatinRosuvastatinLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-575RosuvastatinRosuvastatinQuality Care Products, LLCANDACurrent
61919-701ROSUVASTATIN CALCIUMROSUVASTATIN CALCIUMDIRECT RXANDACurrent
61919-701ROSUVASTATIN CALCIUMROSUVASTATIN CALCIUMDirect_RxANDACurrent
61919-701ROSUVASTATIN CALCIUMROSUVASTATIN CALCIUMDirect_RxANDACurrent
68071-2326RosuvastatinRosuvastatinNuCare Pharmaceuticals,Inc.ANDACurrent
68071-2848RosuvastatinRosuvastatinNuCare Pharmaceuticals,Inc.ANDACurrent
68788-7673RosuvastatinRosuvastatinPreferred Pharmaceuticals, Inc.ANDACurrent
68788-7673RosuvastatinRosuvastatinPreferred Pharmaceuticals, Inc.ANDACurrent
68788-7673RosuvastatinRosuvastatinPreferred Pharmaceuticals, Inc.ANDACurrent
70518-0986RosuvastatinRosuvastatinREMEDYREPACK INC.ANDACurrent
70518-0986RosuvastatinRosuvastatinREMEDYREPACK INC.ANDACurrent
70518-0986RosuvastatinRosuvastatinREMEDYREPACK INC.ANDACurrent
70518-0986RosuvastatinRosuvastatinREMEDYREPACK INC.ANDACurrent
70518-0986RosuvastatinRosuvastatinREMEDYREPACK INC.ANDACurrent
70518-1219RosuvastatinRosuvastatinREMEDYREPACK INC.ANDACurrent
70518-1219RosuvastatinRosuvastatinREMEDYREPACK INC.ANDACurrent
70518-1219RosuvastatinRosuvastatinREMEDYREPACK INC.ANDACurrent
70518-1219RosuvastatinRosuvastatinREMEDYREPACK INC.ANDACurrent
70518-1219RosuvastatinRosuvastatinREMEDYREPACK INC.ANDACurrent
70518-1384RosuvastatinRosuvastatinREMEDYREPACK INC.ANDACurrent
70518-1384RosuvastatinRosuvastatinREMEDYREPACK INC.ANDACurrent
70518-1384RosuvastatinRosuvastatinREMEDYREPACK INC.ANDACurrent
70518-1384RosuvastatinRosuvastatinREMEDYREPACK INC.ANDACurrent
70518-1601RosuvastatinRosuvastatinREMEDYREPACK INC.ANDACurrent
70518-1601RosuvastatinRosuvastatinREMEDYREPACK INC.ANDACurrent
70518-1601RosuvastatinRosuvastatinREMEDYREPACK INC.ANDACurrent
70518-1601RosuvastatinRosuvastatinREMEDYREPACK INC.ANDACurrent
70934-440RosuvastatinRosuvastatinDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
71205-044RosuvastatinRosuvastatinProficient Rx LPANDACurrent
71205-044RosuvastatinRosuvastatinProficient Rx LPANDACurrent
71335-1446RosuvastatinRosuvastatinBryant Ranch PrepackANDACurrent
71335-1446RosuvastatinRosuvastatinBryant Ranch PrepackANDACurrent