Application 207408

Type
ANDA
Sponsor
CHANGZHOU PHARM

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
A207408-001ROSUVASTATIN CALCIUMROSUVASTATIN CALCIUMEQ 5MG BASETABLET / ORALAB2016-10-31
A207408-002ROSUVASTATIN CALCIUMROSUVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2016-10-31
A207408-003ROSUVASTATIN CALCIUMROSUVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2016-10-31
A207408-004ROSUVASTATIN 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
A207408-001AB
A207408-002AB
A207408-003AB
A207408-004AB

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 06:07:402026-07A207408-001ROSUVASTATIN CALCIUMEQ 5MG BASETABLET / ORALAB2016-10-31caaa826d4ba7…
2026-08-18 06:07:402026-07A207408-002ROSUVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2016-10-31caaa826d4ba7…
2026-08-18 06:07:402026-07A207408-003ROSUVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2016-10-31caaa826d4ba7…
2026-08-18 06:07:402026-07A207408-004ROSUVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2016-10-31caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A207408-001ROSUVASTATIN CALCIUMEQ 5MG BASETABLET / ORALAB2016-10-31011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207408-002ROSUVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2016-10-31011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207408-003ROSUVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2016-10-31011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207408-004ROSUVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2016-10-31011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207408-001ROSUVASTATIN CALCIUMEQ 5MG BASETABLET / ORALAB2016-10-3131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207408-002ROSUVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2016-10-3131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207408-003ROSUVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2016-10-3131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207408-004ROSUVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2016-10-3131067a03dcf5…
2025-08-23 18:47 UTC2025-08A207408-001ROSUVASTATIN CALCIUMEQ 5MG BASETABLET / ORALAB2016-10-316a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207408-002ROSUVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2016-10-316a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207408-003ROSUVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2016-10-316a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207408-004ROSUVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2016-10-316a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207408-001ROSUVASTATIN CALCIUMEQ 5MG BASETABLET / ORALAB2016-10-31fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207408-002ROSUVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2016-10-31fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207408-003ROSUVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2016-10-31fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207408-004ROSUVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2016-10-31fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207408-001ROSUVASTATIN CALCIUMEQ 5MG BASETABLET / ORALAB2016-10-31b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207408-002ROSUVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2016-10-31b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207408-003ROSUVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2016-10-31b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207408-004ROSUVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2016-10-31b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207408-001ROSUVASTATIN CALCIUMEQ 5MG BASETABLET / ORALAB2016-10-3103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207408-002ROSUVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2016-10-3103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207408-003ROSUVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2016-10-3103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207408-004ROSUVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2016-10-3103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207408-001ROSUVASTATIN CALCIUMEQ 5MG BASETABLET / ORALAB2016-10-312680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207408-002ROSUVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2016-10-312680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207408-003ROSUVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2016-10-312680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207408-004ROSUVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2016-10-312680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207408-001ROSUVASTATIN CALCIUMEQ 5MG BASETABLET / ORALAB2016-10-315bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207408-002ROSUVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2016-10-315bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207408-003ROSUVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2016-10-315bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207408-004ROSUVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2016-10-315bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207408-001ROSUVASTATIN CALCIUMEQ 5MG BASETABLET / ORALAB2016-10-31d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207408-002ROSUVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2016-10-31d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207408-003ROSUVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2016-10-31d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207408-004ROSUVASTATIN 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 06:07:402026-07A207408-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A207408-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A207408-003AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A207408-004AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A207408-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207408-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207408-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207408-004AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207408-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207408-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207408-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207408-004AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A207408-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207408-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207408-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207408-004AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207408-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207408-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207408-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207408-004AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207408-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207408-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207408-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207408-004AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207408-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207408-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207408-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207408-004AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207408-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207408-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207408-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207408-004AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207408-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207408-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207408-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207408-004AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207408-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207408-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207408-003AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207408-004AB1d8e5a09893c0…

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 · 8 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Rosuvastatin CalciumROSUVASTATIN CALCIUMREMEDYREPACK INC.d9b83920-26ae-462a-ac10-33fd1ed7738f2026-08-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207408
application number: ANDA207408
Rosuvastatin CalciumROSUVASTATIN CALCIUMBryant Ranch Prepack4bd37cda-9928-456c-86be-aaccccf2e4502025-05-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207408
application number: ANDA207408
Rosuvastatin CalciumROSUVASTATIN CALCIUMBryant Ranch Prepackebb0c5d6-d816-44fa-8422-82aa63076d552025-04-28Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207408
application number: ANDA207408
ndc (product): 71335-0905
Rosuvastatin CalciumROSUVASTATIN CALCIUMGolden State Medical Supply, Inc.7c3af5aa-2223-463a-e053-2a91aa0a16f92025-04-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207408
application number: ANDA207408
ndc (product): 51407-154
ndc (product): 51407-156
ndc (product): 51407-153
ndc (product): 51407-155
Rosuvastatin CalciumROSUVASTATIN CALCIUMCranbury Pharmaceuticals, LLC606d16fb-82e4-420d-9456-09997562b5282025-03-27Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207408
application number: ANDA207408
ndc (product): 27808-156
ndc (product): 27808-155
ndc (product): 27808-157
ndc (product): 27808-158
Rosuvastatin CalciumROSUVASTATIN CALCIUMBryant Ranch Prepackc277c6fd-f8dd-41d8-8686-38c25d05d1922024-08-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207408
application number: ANDA207408
ndc (product): 71335-2055
Rosuvastatin CalciumROSUVASTATIN CALCIUMAphena Pharma Solutions - Tennessee, LLCab6c1601-5152-443c-98a0-876660d533e82023-03-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207408
application number: ANDA207408
ndc (product): 71610-232
ndc (product): 71610-234
ndc (product): 71610-233
Rosuvastatin CalciumROSUVASTATIN CALCIUMProficient Rx LPdcc22d05-cff6-42f9-b9fa-930f2084753f2022-05-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207408
application number: ANDA207408
ndc (product): 71205-390
ndc (product): 71205-475

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 40 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
27808-155Rosuvastatin CalciumRosuvastatin CalciumTris Pharma IncANDACurrent
27808-155Rosuvastatin CalciumRosuvastatin CalciumTris Pharma IncANDACurrent
27808-155Rosuvastatin CalciumRosuvastatin CalciumTris Pharma IncANDACurrent
27808-155Rosuvastatin CalciumRosuvastatin CalciumTris Pharma IncANDACurrent
27808-156Rosuvastatin CalciumRosuvastatin CalciumTris Pharma IncANDACurrent
27808-156Rosuvastatin CalciumRosuvastatin CalciumTris Pharma IncANDACurrent
27808-156Rosuvastatin CalciumRosuvastatin CalciumTris Pharma IncANDACurrent
27808-156Rosuvastatin CalciumRosuvastatin CalciumTris Pharma IncANDACurrent
27808-157Rosuvastatin CalciumRosuvastatin CalciumTris Pharma IncANDACurrent
27808-157Rosuvastatin CalciumRosuvastatin CalciumTris Pharma IncANDACurrent
27808-157Rosuvastatin CalciumRosuvastatin CalciumTris Pharma IncANDACurrent
27808-157Rosuvastatin CalciumRosuvastatin CalciumTris Pharma IncANDACurrent
27808-158Rosuvastatin CalciumRosuvastatin CalciumTris Pharma IncANDACurrent
27808-158Rosuvastatin CalciumRosuvastatin CalciumTris Pharma IncANDACurrent
27808-158Rosuvastatin CalciumRosuvastatin CalciumTris Pharma IncANDACurrent
27808-158Rosuvastatin CalciumRosuvastatin CalciumTris Pharma IncANDACurrent
50090-6077Rosuvastatin CalciumRosuvastatin CalciumA-S Medication SolutionsANDACurrent
51407-153Rosuvastatin CalciumRosuvastatin CalciumGolden State Medical Supply Inc.ANDACurrent
51407-153Rosuvastatin CalciumRosuvastatin CalciumGolden State Medical Supply, Inc.ANDACurrent
51407-153Rosuvastatin CalciumRosuvastatin CalciumGolden State Medical Supply, Inc.ANDACurrent
51407-154Rosuvastatin CalciumRosuvastatin CalciumGolden State Medical Supply Inc.ANDACurrent
51407-154Rosuvastatin CalciumRosuvastatin CalciumGolden State Medical Supply, Inc.ANDACurrent
51407-154Rosuvastatin CalciumRosuvastatin CalciumGolden State Medical Supply, Inc.ANDACurrent
51407-155Rosuvastatin CalciumRosuvastatin CalciumGolden State Medical Supply Inc.ANDACurrent
51407-155Rosuvastatin CalciumRosuvastatin CalciumGolden State Medical Supply, Inc.ANDACurrent
51407-155Rosuvastatin CalciumRosuvastatin CalciumGolden State Medical Supply, Inc.ANDACurrent
51407-156Rosuvastatin CalciumRosuvastatin CalciumGolden State Medical Supply Inc.ANDACurrent
51407-156Rosuvastatin CalciumRosuvastatin CalciumGolden State Medical Supply, Inc.ANDACurrent
51407-156Rosuvastatin CalciumRosuvastatin CalciumGolden State Medical Supply, Inc.ANDACurrent
71205-390Rosuvastatin CalciumRosuvastatin CalciumProficient Rx LPANDACurrent
71205-390Rosuvastatin CalciumRosuvastatin CalciumProficient Rx LPANDACurrent
71205-475Rosuvastatin CalciumRosuvastatin CalciumProficient Rx LPANDACurrent
71205-475Rosuvastatin CalciumRosuvastatin CalciumProficient Rx LPANDACurrent
71335-0905Rosuvastatin CalciumRosuvastatin CalciumBryant Ranch PrepackANDACurrent
71335-0905Rosuvastatin CalciumRosuvastatin CalciumBryant Ranch PrepackANDACurrent
71335-0905Rosuvastatin CalciumRosuvastatin CalciumBryant Ranch PrepackANDACurrent
71335-2055Rosuvastatin CalciumRosuvastatin CalciumBryant Ranch PrepackANDACurrent
71610-232Rosuvastatin CalciumRosuvastatin CalciumAphena Pharma Solutions - Tennessee, LLCANDACurrent
71610-233Rosuvastatin CalciumRosuvastatin CalciumAphena Pharma Solutions - Tennessee, LLCANDACurrent
71610-234Rosuvastatin CalciumRosuvastatin CalciumAphena Pharma Solutions - Tennessee, LLCANDACurrent