Application 091226

Type
ANDA
Sponsor
MYLAN PHARMS INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ATORVASTATIN CALCIUMATORVASTATIN CALCIUMTABLET;ORALEQ 10MG BASENoNo
002ATORVASTATIN CALCIUMATORVASTATIN CALCIUMTABLET;ORALEQ 20MG BASENoNo
003ATORVASTATIN CALCIUMATORVASTATIN CALCIUMTABLET;ORALEQ 40MG BASENoNo
004ATORVASTATIN CALCIUMATORVASTATIN CALCIUMTABLET;ORALEQ 80MG BASENoNo

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
A091226-001ATORVASTATIN CALCIUMATORVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2012-05-29
A091226-002ATORVASTATIN CALCIUMATORVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2012-05-29
A091226-003ATORVASTATIN CALCIUMATORVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2012-05-29
A091226-004ATORVASTATIN CALCIUMATORVASTATIN CALCIUMEQ 80MG BASETABLET / ORALAB2012-05-29

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A091226-001AB
A091226-002AB
A091226-003AB
A091226-004AB

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 06:07:402026-07A091226-001ATORVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2012-05-29caaa826d4ba7…
2026-08-18 06:07:402026-07A091226-002ATORVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2012-05-29caaa826d4ba7…
2026-08-18 06:07:402026-07A091226-003ATORVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2012-05-29caaa826d4ba7…
2026-08-18 06:07:402026-07A091226-004ATORVASTATIN CALCIUMEQ 80MG BASETABLET / ORALAB2012-05-29caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A091226-001ATORVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2012-05-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02A091226-002ATORVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2012-05-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02A091226-003ATORVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2012-05-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02A091226-004ATORVASTATIN CALCIUMEQ 80MG BASETABLET / ORALAB2012-05-29011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091226-001ATORVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2012-05-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091226-002ATORVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2012-05-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091226-003ATORVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2012-05-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091226-004ATORVASTATIN CALCIUMEQ 80MG BASETABLET / ORALAB2012-05-2931067a03dcf5…
2025-08-23 18:47 UTC2025-08A091226-001ATORVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2012-05-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08A091226-002ATORVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2012-05-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08A091226-003ATORVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2012-05-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08A091226-004ATORVASTATIN CALCIUMEQ 80MG BASETABLET / ORALAB2012-05-296a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091226-001ATORVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2012-05-29fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091226-002ATORVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2012-05-29fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091226-003ATORVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2012-05-29fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091226-004ATORVASTATIN CALCIUMEQ 80MG BASETABLET / ORALAB2012-05-29fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091226-001ATORVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2012-05-29b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091226-002ATORVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2012-05-29b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091226-003ATORVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2012-05-29b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091226-004ATORVASTATIN CALCIUMEQ 80MG BASETABLET / ORALAB2012-05-29b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091226-001ATORVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2012-05-2903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091226-002ATORVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2012-05-2903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091226-003ATORVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2012-05-2903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091226-004ATORVASTATIN CALCIUMEQ 80MG BASETABLET / ORALAB2012-05-2903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091226-001ATORVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2012-05-292680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091226-002ATORVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2012-05-292680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091226-003ATORVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2012-05-292680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091226-004ATORVASTATIN CALCIUMEQ 80MG BASETABLET / ORALAB2012-05-292680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091226-001ATORVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2012-05-295bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091226-002ATORVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2012-05-295bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091226-003ATORVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2012-05-295bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091226-004ATORVASTATIN CALCIUMEQ 80MG BASETABLET / ORALAB2012-05-295bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091226-001ATORVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2012-05-29d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091226-002ATORVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2012-05-29d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091226-003ATORVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2012-05-29d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091226-004ATORVASTATIN CALCIUMEQ 80MG BASETABLET / ORALAB2012-05-29d8e5a09893c0…

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 06:07:402026-07A091226-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A091226-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A091226-003AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A091226-004AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A091226-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A091226-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A091226-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A091226-004AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091226-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091226-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091226-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091226-004AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A091226-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A091226-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A091226-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A091226-004AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091226-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091226-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091226-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091226-004AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091226-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091226-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091226-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091226-004AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091226-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091226-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091226-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091226-004AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091226-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091226-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091226-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091226-004AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091226-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091226-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091226-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091226-004AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091226-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091226-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091226-003AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091226-004AB1d8e5a09893c0…

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 · 5 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Atorvastatin CalciumATORVASTATIN CALCIUMCardinal Health 107, LLCaee307d6-b3fa-424f-8656-1f30ff413e952026-07-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091226
application number: ANDA091226
ndc (product): 55154-4384
Atorvastatin CalciumATORVASTATIN CALCIUMCardinal Health 107, LLCfbd1c5da-67fb-4412-acb5-4d4c74a436542026-07-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091226
application number: ANDA091226
Atorvastatin CalciumATORVASTATIN CALCIUMMylan Pharmaceuticals Inc.d0a0feb6-84f0-4693-a11f-eb4f7ae0a87d2026-06-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091226
application number: ANDA091226
ndc (product): 0378-3950
ndc (product): 0378-3953
ndc (product): 0378-3952
ndc (product): 0378-3951
Atorvastatin CalciumATORVASTATIN CALCIUMSafecor Health, LLC6d552a6f-d7a2-4dba-8e71-2b97b4ee2faf2026-02-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091226
application number: ANDA091226
Atorvastatin CalciumATORVASTATIN CALCIUMMylan Institutional Inc.7c1083b9-7a20-475d-ba12-4f5d0b53e6012025-07-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091226
application number: ANDA091226
ndc (product): 51079-208
ndc (product): 51079-209
ndc (product): 51079-210
ndc (product): 51079-211

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 73 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0378-3950Atorvastatin Calciumatorvastatin calciumMylan Pharmaceuticals Inc.ANDACurrent
0378-3950Atorvastatin Calciumatorvastatin calciumMylan Pharmaceuticals Inc.ANDACurrent
0378-3950Atorvastatin Calciumatorvastatin calciumMylan Pharmaceuticals IncANDACurrent
0378-3950Atorvastatin Calciumatorvastatin calciumMylan Pharmaceuticals Inc.ANDACurrent
0378-3950Atorvastatin Calciumatorvastatin calciumMylan Pharmaceuticals Inc.ANDACurrent
0378-3950Atorvastatin Calciumatorvastatin calciumMylan Pharmaceuticals Inc.ANDACurrent
0378-3950Atorvastatin Calciumatorvastatin calciumMylan Pharmaceuticals Inc.ANDACurrent
0378-3950Atorvastatin Calciumatorvastatin calciumMylan Pharmaceuticals Inc.ANDACurrent
0378-3951Atorvastatin Calciumatorvastatin calciumMylan Pharmaceuticals Inc.ANDACurrent
0378-3951Atorvastatin Calciumatorvastatin calciumMylan Pharmaceuticals Inc.ANDACurrent
0378-3951Atorvastatin Calciumatorvastatin calciumMylan Pharmaceuticals IncANDACurrent
0378-3951Atorvastatin Calciumatorvastatin calciumMylan Pharmaceuticals Inc.ANDACurrent
0378-3951Atorvastatin Calciumatorvastatin calciumMylan Pharmaceuticals Inc.ANDACurrent
0378-3951Atorvastatin Calciumatorvastatin calciumMylan Pharmaceuticals Inc.ANDACurrent
0378-3951Atorvastatin Calciumatorvastatin calciumMylan Pharmaceuticals Inc.ANDACurrent
0378-3951Atorvastatin Calciumatorvastatin calciumMylan Pharmaceuticals Inc.ANDACurrent
0378-3952Atorvastatin Calciumatorvastatin calciumMylan Pharmaceuticals Inc.ANDACurrent
0378-3952Atorvastatin Calciumatorvastatin calciumMylan Pharmaceuticals Inc.ANDACurrent
0378-3952Atorvastatin Calciumatorvastatin calciumMylan Pharmaceuticals IncANDACurrent
0378-3952Atorvastatin Calciumatorvastatin calciumMylan Pharmaceuticals Inc.ANDACurrent
0378-3952Atorvastatin Calciumatorvastatin calciumMylan Pharmaceuticals Inc.ANDACurrent
0378-3952Atorvastatin Calciumatorvastatin calciumMylan Pharmaceuticals Inc.ANDACurrent
0378-3952Atorvastatin Calciumatorvastatin calciumMylan Pharmaceuticals Inc.ANDACurrent
0378-3952Atorvastatin Calciumatorvastatin calciumMylan Pharmaceuticals Inc.ANDACurrent
0378-3953Atorvastatin Calciumatorvastatin calciumMylan Pharmaceuticals Inc.ANDACurrent
0378-3953Atorvastatin Calciumatorvastatin calciumMylan Pharmaceuticals Inc.ANDACurrent
0378-3953Atorvastatin Calciumatorvastatin calciumMylan Pharmaceuticals IncANDACurrent
0378-3953Atorvastatin Calciumatorvastatin calciumMylan Pharmaceuticals Inc.ANDACurrent
0378-3953Atorvastatin Calciumatorvastatin calciumMylan Pharmaceuticals Inc.ANDACurrent
0378-3953Atorvastatin Calciumatorvastatin calciumMylan Pharmaceuticals Inc.ANDACurrent
0378-3953Atorvastatin Calciumatorvastatin calciumMylan Pharmaceuticals Inc.ANDACurrent
0378-3953Atorvastatin Calciumatorvastatin calciumMylan Pharmaceuticals Inc.ANDACurrent
43353-181Atorvastatin Calciumatorvastatin calciumAphena Pharma Solutions - Tennessee, LLCANDACurrent
43353-181Atorvastatin Calciumatorvastatin calciumAphena Pharma Solutions - Tennessee, LLCANDACurrent
43353-181Atorvastatin Calciumatorvastatin calciumAphena Pharma Solutions - Tennessee, LLCANDACurrent
43353-182Atorvastatin Calciumatorvastatin calciumAphena Pharma Solutions - Tennessee, LLCANDACurrent
43353-182Atorvastatin Calciumatorvastatin calciumAphena Pharma Solutions - Tennessee, LLCANDACurrent
43353-182Atorvastatin Calciumatorvastatin calciumAphena Pharma Solutions - Tennessee, LLCANDACurrent
43353-184Atorvastatin Calciumatorvastatin calciumAphena Pharma Solutions - Tennessee, LLCANDACurrent
43353-184Atorvastatin Calciumatorvastatin calciumAphena Pharma Solutions - Tennessee, LLCANDACurrent
43353-184Atorvastatin Calciumatorvastatin calciumAphena Pharma Solutions - Tennessee, LLCANDACurrent
51079-208Atorvastatin Calciumatorvastatin calciumMylan Institutional Inc.ANDACurrent
51079-208Atorvastatin Calciumatorvastatin calciumMylan Institutional Inc.ANDACurrent
51079-208Atorvastatin Calciumatorvastatin calciumMylan Institutional Inc.ANDACurrent
51079-208Atorvastatin Calciumatorvastatin calciumMylan Institutional Inc.ANDACurrent
51079-208Atorvastatin Calciumatorvastatin calciumMylan Institutional Inc.ANDACurrent
51079-208Atorvastatin Calciumatorvastatin calciumMylan Institutional Inc.ANDACurrent
51079-209Atorvastatin Calciumatorvastatin calciumMylan Institutional Inc.ANDACurrent
51079-209Atorvastatin Calciumatorvastatin calciumMylan Institutional Inc.ANDACurrent
51079-209Atorvastatin Calciumatorvastatin calciumMylan Institutional Inc.ANDACurrent
51079-209Atorvastatin Calciumatorvastatin calciumMylan Institutional Inc.ANDACurrent
51079-209Atorvastatin Calciumatorvastatin calciumMylan Institutional Inc.ANDACurrent
51079-209Atorvastatin Calciumatorvastatin calciumMylan Institutional Inc.ANDACurrent
51079-210Atorvastatin Calciumatorvastatin calciumMylan Institutional Inc.ANDACurrent
51079-210Atorvastatin Calciumatorvastatin calciumMylan Institutional Inc.ANDACurrent
51079-210Atorvastatin Calciumatorvastatin calciumMylan Institutional Inc.ANDACurrent
51079-210Atorvastatin Calciumatorvastatin calciumMylan Institutional Inc.ANDACurrent
51079-210Atorvastatin Calciumatorvastatin calciumMylan Institutional Inc.ANDACurrent
51079-210Atorvastatin Calciumatorvastatin calciumMylan Institutional Inc.ANDACurrent
51079-211Atorvastatin Calciumatorvastatin calciumMylan Institutional Inc.ANDACurrent
51079-211Atorvastatin Calciumatorvastatin calciumMylan Institutional Inc.ANDACurrent
51079-211Atorvastatin Calciumatorvastatin calciumMylan Institutional Inc.ANDACurrent
51079-211Atorvastatin Calciumatorvastatin calciumMylan Institutional Inc.ANDACurrent
51079-211Atorvastatin Calciumatorvastatin calciumMylan Institutional Inc.ANDACurrent
51079-211Atorvastatin Calciumatorvastatin calciumMylan Institutional Inc.ANDACurrent
55154-4384Atorvastatin Calciumatorvastatin calciumCardinal HealthANDACurrent
55154-4384Atorvastatin Calciumatorvastatin calciumCardinal HealthANDACurrent
55154-4384Atorvastatin Calciumatorvastatin calciumCardinal Health 107, LLCANDACurrent
55154-4384Atorvastatin Calciumatorvastatin calciumCardinal HealthANDACurrent
70518-0198Atorvastatin Calciumatorvastatin calciumREMEDYREPACK INC.ANDACurrent
70518-0462Atorvastatin Calciumatorvastatin calciumREMEDYREPACK INC.ANDACurrent
70518-0567Atorvastatin Calciumatorvastatin calciumREMEDYREPACK INC.ANDACurrent
70518-0567Atorvastatin Calciumatorvastatin calciumREMEDYREPACK INC.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
57221SUPPL2019-01-15
22723ORIG2015-03-09