Application 205300

Type
ANDA
Sponsor
TEVA PHARMS USA

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 1.

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
A205300-001ATORVASTATIN CALCIUMATORVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2017-03-27
A205300-002ATORVASTATIN CALCIUMATORVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2017-03-27
A205300-003ATORVASTATIN CALCIUMATORVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2017-03-27
A205300-004ATORVASTATIN CALCIUMATORVASTATIN CALCIUMEQ 80MG BASETABLET / ORALAB2017-03-27

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A205300-001AB
A205300-002AB
A205300-003AB
A205300-004AB

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 · 164 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A205300-001ATORVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2017-03-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02A205300-002ATORVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2017-03-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02A205300-003ATORVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2017-03-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02A205300-004ATORVASTATIN CALCIUMEQ 80MG BASETABLET / ORALAB2017-03-27011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205300-001ATORVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2017-03-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205300-002ATORVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2017-03-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205300-003ATORVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2017-03-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205300-004ATORVASTATIN CALCIUMEQ 80MG BASETABLET / ORALAB2017-03-2731067a03dcf5…
2025-08-23 18:47 UTC2025-08A205300-001ATORVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2017-03-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08A205300-002ATORVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2017-03-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08A205300-003ATORVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2017-03-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08A205300-004ATORVASTATIN CALCIUMEQ 80MG BASETABLET / ORALAB2017-03-276a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205300-001ATORVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2017-03-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205300-002ATORVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2017-03-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205300-003ATORVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2017-03-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205300-004ATORVASTATIN CALCIUMEQ 80MG BASETABLET / ORALAB2017-03-27fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205300-001ATORVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2017-03-27b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205300-002ATORVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2017-03-27b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205300-003ATORVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2017-03-27b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205300-004ATORVASTATIN CALCIUMEQ 80MG BASETABLET / ORALAB2017-03-27b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205300-001ATORVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2017-03-2703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205300-002ATORVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2017-03-2703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205300-003ATORVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2017-03-2703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205300-004ATORVASTATIN CALCIUMEQ 80MG BASETABLET / ORALAB2017-03-2703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205300-001ATORVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2017-03-272680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205300-002ATORVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2017-03-272680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205300-003ATORVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2017-03-272680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205300-004ATORVASTATIN CALCIUMEQ 80MG BASETABLET / ORALAB2017-03-272680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A205300-001ATORVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2017-03-275bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A205300-002ATORVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2017-03-275bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A205300-003ATORVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2017-03-275bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A205300-004ATORVASTATIN CALCIUMEQ 80MG BASETABLET / ORALAB2017-03-275bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A205300-001ATORVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2017-03-27d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A205300-002ATORVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2017-03-27d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A205300-003ATORVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2017-03-27d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A205300-004ATORVASTATIN CALCIUMEQ 80MG BASETABLET / ORALAB2017-03-27d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A205300-001ATORVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2017-03-27d06236e962d9…
2024-10-29 15:01 UTC2024-10A205300-002ATORVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2017-03-27d06236e962d9…
2024-10-29 15:01 UTC2024-10A205300-003ATORVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2017-03-27d06236e962d9…
2024-10-29 15:01 UTC2024-10A205300-004ATORVASTATIN CALCIUMEQ 80MG BASETABLET / ORALAB2017-03-27d06236e962d9…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 164 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A205300-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A205300-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A205300-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A205300-004AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205300-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205300-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205300-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205300-004AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A205300-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A205300-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A205300-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A205300-004AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205300-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205300-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205300-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205300-004AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205300-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205300-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205300-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205300-004AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205300-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205300-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205300-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205300-004AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205300-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205300-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205300-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205300-004AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A205300-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A205300-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A205300-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A205300-004AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A205300-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A205300-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A205300-003AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A205300-004AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A205300-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A205300-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A205300-003AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A205300-004AB1d06236e962d9…

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
Atorvastatin CalciumATORVASTATIN CALCIUMQPharma, Inc.3e59aa97-5480-41e0-86b0-047e648b976d2025-12-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205300
application number: ANDA205300
ndc (product): 42708-003
ndc (product): 42708-005
ndc (product): 42708-004
Atorvastatin CalciumATORVASTATIN CALCIUMTeva Pharmaceuticals USA, Inc.86841382-4229-4e03-958e-3ac22639efd42024-06-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205300
application number: ANDA205300
ndc (product): 0093-5057
ndc (product): 0093-5056
ndc (product): 0093-5058
ndc (product): 0093-5059
Atorvastatin CalciumATORVASTATIN CALCIUMProficient Rx LPbd56a76b-5570-46a7-9399-fc110d913bf92019-10-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205300
application number: ANDA205300
ndc (product): 71205-098

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 56 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0093-5056Atorvastatin CalciumAtorvastatin CalciumTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-5056Atorvastatin CalciumAtorvastatin CalciumTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-5056Atorvastatin CalciumAtorvastatin CalciumTeva Pharmaceuticals USA,ANDACurrent
0093-5056Atorvastatin CalciumAtorvastatin CalciumTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-5056Atorvastatin CalciumAtorvastatin CalciumTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-5056Atorvastatin CalciumAtorvastatin CalciumTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-5056Atorvastatin CalciumAtorvastatin CalciumTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-5056Atorvastatin CalciumAtorvastatin CalciumTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-5057Atorvastatin CalciumAtorvastatin CalciumTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-5057Atorvastatin CalciumAtorvastatin CalciumTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-5057Atorvastatin CalciumAtorvastatin CalciumTeva Pharmaceuticals USA,ANDACurrent
0093-5057Atorvastatin CalciumAtorvastatin CalciumTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-5057Atorvastatin CalciumAtorvastatin CalciumTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-5057Atorvastatin CalciumAtorvastatin CalciumTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-5057Atorvastatin CalciumAtorvastatin CalciumTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-5057Atorvastatin CalciumAtorvastatin CalciumTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-5058Atorvastatin CalciumAtorvastatin CalciumTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-5058Atorvastatin CalciumAtorvastatin CalciumTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-5058Atorvastatin CalciumAtorvastatin CalciumTeva Pharmaceuticals USA,ANDACurrent
0093-5058Atorvastatin CalciumAtorvastatin CalciumTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-5058Atorvastatin CalciumAtorvastatin CalciumTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-5058Atorvastatin CalciumAtorvastatin CalciumTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-5058Atorvastatin CalciumAtorvastatin CalciumTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-5058Atorvastatin CalciumAtorvastatin CalciumTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-5059Atorvastatin CalciumAtorvastatin CalciumTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-5059Atorvastatin CalciumAtorvastatin CalciumTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-5059Atorvastatin CalciumAtorvastatin CalciumTeva Pharmaceuticals USA,ANDACurrent
0093-5059Atorvastatin CalciumAtorvastatin CalciumTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-5059Atorvastatin CalciumAtorvastatin CalciumTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-5059Atorvastatin CalciumAtorvastatin CalciumTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-5059Atorvastatin CalciumAtorvastatin CalciumTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-5059Atorvastatin CalciumAtorvastatin CalciumTeva Pharmaceuticals USA, Inc.ANDACurrent
42708-003Atorvastatin CalciumAtorvastatin CalciumQPharma IncANDACurrent
42708-003Atorvastatin CalciumAtorvastatin CalciumQPharma IncANDACurrent
42708-003Atorvastatin CalciumAtorvastatin CalciumQPharma IncANDACurrent
42708-004Atorvastatin CalciumAtorvastatin CalciumQPharma IncANDACurrent
42708-004Atorvastatin CalciumAtorvastatin CalciumQPharma IncANDACurrent
42708-004Atorvastatin CalciumAtorvastatin CalciumQPharma IncANDACurrent
42708-005Atorvastatin CalciumAtorvastatin CalciumQPharma IncANDACurrent
42708-005Atorvastatin CalciumAtorvastatin CalciumQPharma IncANDACurrent
42708-005Atorvastatin CalciumAtorvastatin CalciumQPharma IncANDACurrent
45865-727Atorvastatin CalciumAtorvastatin Calciummedsource pharmaceuticalsANDACurrent
63629-0087Atorvastatin CalciumAtorvastatin CalciumBryant Ranch PrepackANDACurrent
63629-0087Atorvastatin CalciumAtorvastatin CalciumBryant Ranch PrepackANDACurrent
63629-0087Atorvastatin CalciumAtorvastatin CalciumBryant Ranch PrepackANDACurrent
68071-3371Atorvastatin CalciumAtorvastatin CalciumNuCare Pharmaceuticals,Inc.ANDACurrent
68071-3374Atorvastatin CalciumAtorvastatin CalciumNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4185Atorvastatin CalciumAtorvastatin CalciumNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4472Atorvastatin CalciumAtorvastatin CalciumNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4472Atorvastatin CalciumAtorvastatin CalciumNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4472Atorvastatin CalciumAtorvastatin CalciumNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4506Atorvastatin CalciumAtorvastatin CalciumNuCare Pharmaceuticals,Inc.ANDACurrent
70518-0813Atorvastatin CalciumAtorvastatin CalciumREMEDYREPACK INC.ANDACurrent
70518-0813Atorvastatin CalciumAtorvastatin CalciumREMEDYREPACK INC.ANDACurrent
71205-098Atorvastatin CalciumAtorvastatin CalciumProficient Rx LPANDACurrent
71205-098Atorvastatin CalciumAtorvastatin CalciumProficient Rx LPANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
47762ORIG2017-03-29