Application 208898

Type
ANDA
Sponsor
MSN

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 43.

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
A208898-001ROSUVASTATIN CALCIUMROSUVASTATIN CALCIUMEQ 5MG BASETABLET / ORALAB2017-11-22
A208898-002ROSUVASTATIN CALCIUMROSUVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2017-11-22
A208898-003ROSUVASTATIN CALCIUMROSUVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2017-11-22
A208898-004ROSUVASTATIN CALCIUMROSUVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2017-11-22

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A208898-001AB
A208898-002AB
A208898-003AB
A208898-004AB

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 · 172 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A208898-001ROSUVASTATIN CALCIUMEQ 5MG BASETABLET / ORALAB2017-11-2284e616aacf4f…
2026-09-14 22:38:342026-08A208898-002ROSUVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2017-11-2284e616aacf4f…
2026-09-14 22:38:342026-08A208898-003ROSUVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2017-11-2284e616aacf4f…
2026-09-14 22:38:342026-08A208898-004ROSUVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2017-11-2284e616aacf4f…
2026-08-18 06:07:402026-07A208898-001ROSUVASTATIN CALCIUMEQ 5MG BASETABLET / ORALAB2017-11-22caaa826d4ba7…
2026-08-18 06:07:402026-07A208898-002ROSUVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2017-11-22caaa826d4ba7…
2026-08-18 06:07:402026-07A208898-003ROSUVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2017-11-22caaa826d4ba7…
2026-08-18 06:07:402026-07A208898-004ROSUVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2017-11-22caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A208898-001ROSUVASTATIN CALCIUMEQ 5MG BASETABLET / ORALAB2017-11-22011fe1cb6892…
2026-02-19 14:30 UTC2026-02A208898-002ROSUVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2017-11-22011fe1cb6892…
2026-02-19 14:30 UTC2026-02A208898-003ROSUVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2017-11-22011fe1cb6892…
2026-02-19 14:30 UTC2026-02A208898-004ROSUVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2017-11-22011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208898-001ROSUVASTATIN CALCIUMEQ 5MG BASETABLET / ORALAB2017-11-2231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208898-002ROSUVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2017-11-2231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208898-003ROSUVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2017-11-2231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208898-004ROSUVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2017-11-2231067a03dcf5…
2025-08-23 18:47 UTC2025-08A208898-001ROSUVASTATIN CALCIUMEQ 5MG BASETABLET / ORALAB2017-11-226a471c1ec25d…
2025-08-23 18:47 UTC2025-08A208898-002ROSUVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2017-11-226a471c1ec25d…
2025-08-23 18:47 UTC2025-08A208898-003ROSUVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2017-11-226a471c1ec25d…
2025-08-23 18:47 UTC2025-08A208898-004ROSUVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2017-11-226a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208898-001ROSUVASTATIN CALCIUMEQ 5MG BASETABLET / ORALAB2017-11-22fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208898-002ROSUVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2017-11-22fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208898-003ROSUVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2017-11-22fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208898-004ROSUVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2017-11-22fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208898-001ROSUVASTATIN CALCIUMEQ 5MG BASETABLET / ORALAB2017-11-22b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208898-002ROSUVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2017-11-22b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208898-003ROSUVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2017-11-22b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208898-004ROSUVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2017-11-22b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208898-001ROSUVASTATIN CALCIUMEQ 5MG BASETABLET / ORALAB2017-11-2203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208898-002ROSUVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2017-11-2203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208898-003ROSUVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2017-11-2203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208898-004ROSUVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2017-11-2203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208898-001ROSUVASTATIN CALCIUMEQ 5MG BASETABLET / ORALAB2017-11-222680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208898-002ROSUVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2017-11-222680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208898-003ROSUVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2017-11-222680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208898-004ROSUVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2017-11-222680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A208898-001ROSUVASTATIN CALCIUMEQ 5MG BASETABLET / ORALAB2017-11-225bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A208898-002ROSUVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2017-11-225bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A208898-003ROSUVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2017-11-225bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A208898-004ROSUVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2017-11-225bbf6a4d5a75…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 172 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A208898-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A208898-002AB184e616aacf4f…
2026-09-14 22:38:342026-08A208898-003AB184e616aacf4f…
2026-09-14 22:38:342026-08A208898-004AB184e616aacf4f…
2026-08-18 06:07:402026-07A208898-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A208898-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A208898-003AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A208898-004AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A208898-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A208898-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A208898-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A208898-004AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208898-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208898-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208898-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208898-004AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A208898-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A208898-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A208898-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A208898-004AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208898-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208898-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208898-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208898-004AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208898-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208898-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208898-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208898-004AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208898-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208898-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208898-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208898-004AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208898-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208898-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208898-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208898-004AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A208898-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A208898-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A208898-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A208898-004AB15bbf6a4d5a75…

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 2 · 25 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Rosuvastatin CalciumROSUVASTATIN CALCIUMPreferred Pharmaceuticals, Inc.6ef51f7c-2899-4b09-bf8b-09e5b4ac34242026-08-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208898
application number: ANDA208898
Rosuvastatin CalciumROSUVASTATIN CALCIUMPreferred Pharmaceuticals Inc.b94b5b36-c04e-45ee-b933-59c4302f26612026-08-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208898
application number: ANDA208898
Rosuvastatin CalciumROSUVASTATIN CALCIUMREMEDYREPACK INC.11fad602-16c2-4c1f-bdf1-867d95f063ca2026-07-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208898
application number: ANDA208898
ROSUVASTATINROSUVASTATINDIRECT RX99602058-4681-7cb5-e053-2995a90a099c2026-03-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208898
application number: ANDA208898
ndc (product): 72189-065
ndc (product): 72189-106
Rosuvastatin CalciumROSUVASTATIN CALCIUMNuCare Pharmaceuticals,Inc.be73cea2-f89a-e4c5-e053-2a95a90a9cce2026-03-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208898
application number: ANDA208898
Rosuvastatin CalciumROSUVASTATIN CALCIUMNorthwind Health Company, LLCf2a1008e-963c-9999-e053-2a95a90ae7262026-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208898
application number: ANDA208898
Rosuvastatin CalciumROSUVASTATIN CALCIUMNorthwind Health Company, LLCe3d92523-2dbe-930b-e053-2a95a90ac3f22026-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208898
application number: ANDA208898
Rosuvastatin CalciumROSUVASTATIN CALCIUMQuallent Pharmaceuticals Health LLC6f978191-775e-4745-9c07-99e5be888afe2025-02-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208898
application number: ANDA208898
ndc (product): 82009-017
ndc (product): 82009-018
ndc (product): 82009-019
ndc (product): 82009-020
Rosuvastatin CalciumROSUVASTATIN CALCIUMProficient Rx LPdc7bfc79-9ee3-46e7-b55d-aba88648ad3b2024-12-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208898
application number: ANDA208898
Rosuvastatin CalciumROSUVASTATIN CALCIUMNovadoz Pharmaceuticals LLCd58f1f63-4bb6-413c-9730-ded3e80786182024-11-28Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208898
application number: ANDA208898
ndc (product): 72205-005
ndc (product): 72205-002
ndc (product): 72205-027
ndc (product): 72205-004
ndc (product): 72205-003
Rosuvastatin CalciumROSUVASTATIN CALCIUMBryant Ranch Prepacka9a5641f-9b7d-4a98-8dac-a3c53dde861f2024-08-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208898
application number: ANDA208898
Rosuvastatin CalciumROSUVASTATIN CALCIUMBryant Ranch Prepack199df185-dab0-4de1-95f7-a70e57b9c2b12024-08-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208898
application number: ANDA208898
ndc (product): 71335-1330
Rosuvastatin CalciumROSUVASTATIN CALCIUMA-S Medication Solutionsaaadbf01-9cf4-4898-9a96-f0a20d55702b2024-08-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208898
application number: ANDA208898
Rosuvastatin CalciumROSUVASTATIN CALCIUMNuCare Pharmaceuticals,Inc.9e694f6a-63a0-55e9-e053-2995a90a10fe2024-06-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208898
application number: ANDA208898
Rosuvastatin CalciumROSUVASTATIN CALCIUMNuCare Pharmaceuticals,Inc.a2155aff-bf13-3f00-e053-2995a90a4d1d2024-06-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208898
application number: ANDA208898
Rosuvastatin CalciumROSUVASTATIN CALCIUMBryant Ranch Prepackd6645266-9626-430e-bf04-b6426525ae0a2024-05-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208898
application number: ANDA208898
Rosuvastatin CalciumROSUVASTATIN CALCIUMProficient Rx LP3a03022c-ef11-4a68-829f-fae2d31969df2024-03-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208898
application number: ANDA208898
Rosuvastatin CalciumROSUVASTATIN CALCIUMA-S Medication Solutions7ec15f53-a7ec-4be5-9f26-d1078117b18b2023-12-28Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208898
application number: ANDA208898
Rosuvastatin CalciumROSUVASTATIN CALCIUMBryant Ranch Prepack8795a783-755d-426b-aa4f-1fc9965ba9442023-11-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208898
application number: ANDA208898
Rosuvastatin CalciumROSUVASTATIN CALCIUMBryant Ranch Prepackadcbfc8c-e4a7-4576-9f0a-42c59c6e2ad12023-11-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208898
application number: ANDA208898
ndc (product): 71335-1733

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 2 of 2 · 110 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
71335-1330Rosuvastatin CalciumRosuvastatin CalciumBryant Ranch PrepackANDACurrent
71335-1733Rosuvastatin CalciumRosuvastatin CalciumBryant Ranch PrepackANDACurrent
71335-1733Rosuvastatin CalciumRosuvastatin CalciumBryant Ranch PrepackANDACurrent
72189-065ROSUVASTATINROSUVASTATINDIRECT RXANDACurrent
72189-065ROSUVASTATINROSUVASTATINDIRECT RXANDACurrent
72189-065ROSUVASTATINROSUVASTATINDIRECT RXANDACurrent
72189-106ROSUVASTATIN CALCIUMROSUVASTATIN CALCIUMDIRECT RXANDACurrent
72189-106ROSUVASTATIN CALCIUMROSUVASTATIN CALCIUMDIRECT RXANDACurrent
72205-002Rosuvastatin CalciumRosuvastatin CalciumNovadoz Pharmaceuticals LLCANDACurrent
72205-002Rosuvastatin CalciumRosuvastatin CalciumNovadoz Pharmaceuticals LLCANDACurrent
72205-002Rosuvastatin CalciumRosuvastatin CalciumNovadoz Pharmaceuticals LLCANDACurrent
72205-003Rosuvastatin CalciumRosuvastatin CalciumNovadoz Pharmaceuticals LLCANDACurrent
72205-003Rosuvastatin CalciumRosuvastatin CalciumNovadoz Pharmaceuticals LLCANDACurrent
72205-003Rosuvastatin CalciumRosuvastatin CalciumNovadoz Pharmaceuticals LLCANDACurrent
72205-004Rosuvastatin CalciumRosuvastatin CalciumNovadoz Pharmaceuticals LLCANDACurrent
72205-004Rosuvastatin CalciumRosuvastatin CalciumNovadoz Pharmaceuticals LLCANDACurrent
72205-004Rosuvastatin CalciumRosuvastatin CalciumNovadoz Pharmaceuticals LLCANDACurrent
72205-005Rosuvastatin CalciumRosuvastatin CalciumNovadoz Pharmaceuticals LLCANDACurrent
72205-005Rosuvastatin CalciumRosuvastatin CalciumNovadoz Pharmaceuticals LLCANDACurrent
72205-005Rosuvastatin CalciumRosuvastatin CalciumNovadoz Pharmaceuticals LLCANDACurrent
72205-027Rosuvastatin CalciumRosuvastatin CalciumNovadoz Pharmaceuticals LLCANDACurrent
72205-027Rosuvastatin CalciumRosuvastatin CalciumNovadoz Pharmaceuticals LLCANDACurrent
82009-017Rosuvastatin CalciumRosuvastatin CalciumQUALLENTANDACurrent
82009-017Rosuvastatin CalciumRosuvastatin CalciumQUALLENTANDACurrent
82009-018Rosuvastatin CalciumRosuvastatin CalciumQUALLENTANDACurrent
82009-018Rosuvastatin CalciumRosuvastatin CalciumQUALLENTANDACurrent
82009-019Rosuvastatin CalciumRosuvastatin CalciumQUALLENTANDACurrent
82009-019Rosuvastatin CalciumRosuvastatin CalciumQUALLENTANDACurrent
82009-020Rosuvastatin CalciumRosuvastatin CalciumQUALLENTANDACurrent
82009-020Rosuvastatin CalciumRosuvastatin CalciumQUALLENTANDACurrent