FDA.reportPublic FDA data

Application 202050

Type
ANDA
Sponsor
AUROBINDO PHARMA LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001OLANZAPINEOLANZAPINETABLET;ORAL2.5MGNoNo
002OLANZAPINEOLANZAPINETABLET;ORAL5MGNoNo
003OLANZAPINEOLANZAPINETABLET;ORAL7.5MGNoNo
004OLANZAPINEOLANZAPINETABLET;ORAL10MGNoNo
005OLANZAPINEOLANZAPINETABLET;ORAL15MGNoNo
006OLANZAPINEOLANZAPINETABLET;ORAL20MGNoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 6 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A202050-001OLANZAPINEOLANZAPINE2.5MGTABLET / ORALAB2012-04-23
A202050-002OLANZAPINEOLANZAPINE5MGTABLET / ORALAB2012-04-23
A202050-003OLANZAPINEOLANZAPINE7.5MGTABLET / ORALAB2012-04-23
A202050-004OLANZAPINEOLANZAPINE10MGTABLET / ORALAB2012-04-23
A202050-005OLANZAPINEOLANZAPINE15MGTABLET / ORALAB2012-04-23
A202050-006OLANZAPINEOLANZAPINE20MGTABLET / ORALAB2012-04-23

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 6 matching rows.

Application-product, TE code table
Application-productTE code
A202050-001AB
A202050-002AB
A202050-003AB
A202050-004AB
A202050-005AB
A202050-006AB

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 7 · 258 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A202050-001OLANZAPINE2.5MGTABLET / ORALAB2012-04-2384e616aacf4f…
2026-09-14 22:38:342026-08A202050-002OLANZAPINE5MGTABLET / ORALAB2012-04-2384e616aacf4f…
2026-09-14 22:38:342026-08A202050-003OLANZAPINE7.5MGTABLET / ORALAB2012-04-2384e616aacf4f…
2026-09-14 22:38:342026-08A202050-004OLANZAPINE10MGTABLET / ORALAB2012-04-2384e616aacf4f…
2026-09-14 22:38:342026-08A202050-005OLANZAPINE15MGTABLET / ORALAB2012-04-2384e616aacf4f…
2026-09-14 22:38:342026-08A202050-006OLANZAPINE20MGTABLET / ORALAB2012-04-2384e616aacf4f…
2026-08-18 06:07:402026-07A202050-001OLANZAPINE2.5MGTABLET / ORALAB2012-04-23caaa826d4ba7…
2026-08-18 06:07:402026-07A202050-002OLANZAPINE5MGTABLET / ORALAB2012-04-23caaa826d4ba7…
2026-08-18 06:07:402026-07A202050-003OLANZAPINE7.5MGTABLET / ORALAB2012-04-23caaa826d4ba7…
2026-08-18 06:07:402026-07A202050-004OLANZAPINE10MGTABLET / ORALAB2012-04-23caaa826d4ba7…
2026-08-18 06:07:402026-07A202050-005OLANZAPINE15MGTABLET / ORALAB2012-04-23caaa826d4ba7…
2026-08-18 06:07:402026-07A202050-006OLANZAPINE20MGTABLET / ORALAB2012-04-23caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A202050-001OLANZAPINE2.5MGTABLET / ORALAB2012-04-23011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202050-002OLANZAPINE5MGTABLET / ORALAB2012-04-23011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202050-003OLANZAPINE7.5MGTABLET / ORALAB2012-04-23011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202050-004OLANZAPINE10MGTABLET / ORALAB2012-04-23011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202050-005OLANZAPINE15MGTABLET / ORALAB2012-04-23011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202050-006OLANZAPINE20MGTABLET / ORALAB2012-04-23011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202050-001OLANZAPINE2.5MGTABLET / ORALAB2012-04-2331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202050-002OLANZAPINE5MGTABLET / ORALAB2012-04-2331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202050-003OLANZAPINE7.5MGTABLET / ORALAB2012-04-2331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202050-004OLANZAPINE10MGTABLET / ORALAB2012-04-2331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202050-005OLANZAPINE15MGTABLET / ORALAB2012-04-2331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202050-006OLANZAPINE20MGTABLET / ORALAB2012-04-2331067a03dcf5…
2025-08-23 18:47 UTC2025-08A202050-001OLANZAPINE2.5MGTABLET / ORALAB2012-04-236a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202050-002OLANZAPINE5MGTABLET / ORALAB2012-04-236a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202050-003OLANZAPINE7.5MGTABLET / ORALAB2012-04-236a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202050-004OLANZAPINE10MGTABLET / ORALAB2012-04-236a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202050-005OLANZAPINE15MGTABLET / ORALAB2012-04-236a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202050-006OLANZAPINE20MGTABLET / ORALAB2012-04-236a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202050-001OLANZAPINE2.5MGTABLET / ORALAB2012-04-23fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202050-002OLANZAPINE5MGTABLET / ORALAB2012-04-23fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202050-003OLANZAPINE7.5MGTABLET / ORALAB2012-04-23fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202050-004OLANZAPINE10MGTABLET / ORALAB2012-04-23fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202050-005OLANZAPINE15MGTABLET / ORALAB2012-04-23fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202050-006OLANZAPINE20MGTABLET / ORALAB2012-04-23fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202050-001OLANZAPINE2.5MGTABLET / ORALAB2012-04-23b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202050-002OLANZAPINE5MGTABLET / ORALAB2012-04-23b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202050-003OLANZAPINE7.5MGTABLET / ORALAB2012-04-23b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202050-004OLANZAPINE10MGTABLET / ORALAB2012-04-23b8a1b40f171c…

Observed Orange Book normalized TE history#

Normalized TE history page 2 of 7 · 258 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202050-005AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202050-006AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202050-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202050-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202050-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202050-004AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202050-005AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202050-006AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202050-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202050-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202050-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202050-004AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202050-005AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202050-006AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202050-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202050-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202050-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202050-004AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202050-005AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202050-006AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202050-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202050-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202050-003AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202050-004AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202050-005AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202050-006AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A202050-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A202050-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A202050-003AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A202050-004AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A202050-005AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A202050-006AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202050-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202050-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202050-003AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202050-004AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202050-005AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202050-006AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202050-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202050-002AB1301d65b070ca…

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
OlanzapineOLANZAPINEBryant Ranch Prepack4e90e30c-78a1-486f-a13c-f1ff798216be2026-05-21Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202050
application number: ANDA202050
ndc (product): 71335-1936
OlanzapineOLANZAPINEAurobindo Pharma Limited636665be-9d7e-443a-8134-e8cc47e6ba242026-02-10Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202050
application number: ANDA202050
ndc (product): 65862-564
ndc (product): 65862-561
ndc (product): 65862-566
ndc (product): 65862-565
ndc (product): 65862-563
ndc (product): 65862-562

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 1 of 1 · 79 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
35573-422OLANZAPINEolanzapineBurel Pharmaceuticals, LLCANDACurrent
35573-423OLANZAPINEolanzapineBurel Pharmaceuticals, LLCANDACurrent
35573-424OLANZAPINEOlanzapineBurel Pharmaceuticals, LLCANDACurrent
35573-425OLANZAPINEOlanzapineBurel Pharmaceuticals, LLCANDACurrent
35573-426OLANZAPINEOlanzapineBurel Pharmaceuticals, LLCANDACurrent
35573-427OLANZAPINEolanzapineBurel Pharmaceuticals, LLCANDACurrent
52343-038OLANZAPINEolanzapineACETRIS HEALTH, LLCANDACurrent
52343-038OLANZAPINEolanzapineACETRIS HEALTH, LLCANDACurrent
52343-039OLANZAPINEolanzapineACETRIS HEALTH, LLCANDACurrent
52343-039OLANZAPINEolanzapineACETRIS HEALTH, LLCANDACurrent
52343-040OLANZAPINEOlanzapineACETRIS HEALTH, LLCANDACurrent
52343-040OLANZAPINEOlanzapineACETRIS HEALTH, LLCANDACurrent
52343-041OLANZAPINEOlanzapineACETRIS HEALTH, LLCANDACurrent
52343-041OLANZAPINEOlanzapineACETRIS HEALTH, LLCANDACurrent
52343-042OLANZAPINEOlanzapineACETRIS HEALTH, LLCANDACurrent
52343-042OLANZAPINEOlanzapineACETRIS HEALTH, LLCANDACurrent
52343-043OLANZAPINEOlanzapineACETRIS HEALTH, LLCANDACurrent
52343-043OLANZAPINEOlanzapineACETRIS HEALTH, LLCANDACurrent
65862-561OlanzapineOlanzapineAurobindo Pharma LimitedANDACurrent
65862-561OlanzapineOlanzapineAurobindo Pharma LimitedANDACurrent
65862-561OlanzapineOlanzapineAurobindo Pharma LimitedANDACurrent
65862-561OlanzapineOlanzapineAurobindo Pharma LimitedANDACurrent
65862-561OlanzapineOlanzapineAurobindo Pharma LimitedANDACurrent
65862-562OlanzapineOlanzapineAurobindo Pharma LimitedANDACurrent
65862-562OlanzapineOlanzapineAurobindo Pharma LimitedANDACurrent
65862-562OlanzapineOlanzapineAurobindo Pharma LimitedANDACurrent
65862-562OlanzapineOlanzapineAurobindo Pharma LimitedANDACurrent
65862-562OlanzapineOlanzapineAurobindo Pharma LimitedANDACurrent
65862-563OlanzapineOlanzapineAurobindo Pharma LimitedANDACurrent
65862-563OlanzapineOlanzapineAurobindo Pharma LimitedANDACurrent
65862-563OlanzapineOlanzapineAurobindo Pharma LimitedANDACurrent
65862-563OlanzapineOlanzapineAurobindo Pharma LimitedANDACurrent
65862-563OlanzapineOlanzapineAurobindo Pharma LimitedANDACurrent
65862-564OlanzapineOlanzapineAurobindo Pharma LimitedANDACurrent
65862-564OlanzapineOlanzapineAurobindo Pharma LimitedANDACurrent
65862-564OlanzapineOlanzapineAurobindo Pharma LimitedANDACurrent
65862-564OlanzapineOlanzapineAurobindo Pharma LimitedANDACurrent
65862-564OlanzapineOlanzapineAurobindo Pharma LimitedANDACurrent
65862-565OlanzapineOlanzapineAurobindo Pharma LimitedANDACurrent
65862-565OlanzapineOlanzapineAurobindo Pharma LimitedANDACurrent
65862-565OlanzapineOlanzapineAurobindo Pharma LimitedANDACurrent
65862-565OlanzapineOlanzapineAurobindo Pharma LimitedANDACurrent
65862-565OlanzapineOlanzapineAurobindo Pharma LimitedANDACurrent
65862-566OlanzapineOlanzapineAurobindo Pharma LimitedANDACurrent
65862-566OlanzapineOlanzapineAurobindo Pharma LimitedANDACurrent
65862-566OlanzapineOlanzapineAurobindo Pharma LimitedANDACurrent
65862-566OlanzapineOlanzapineAurobindo Pharma LimitedANDACurrent
65862-566OlanzapineOlanzapineAurobindo Pharma LimitedANDACurrent
66993-680OLANZAPINEolanzapinePrasco LaboratoriesANDACurrent
66993-680OLANZAPINEolanzapinePrasco LaboratoriesANDACurrent
66993-680OLANZAPINEolanzapinePrasco LaboratoriesANDACurrent
66993-680OLANZAPINEolanzapinePrasco LaboratoriesANDACurrent
66993-681OLANZAPINEolanzapinePrasco LaboratoriesANDACurrent
66993-681OLANZAPINEolanzapinePrasco LaboratoriesANDACurrent
66993-681OLANZAPINEolanzapinePrasco LaboratoriesANDACurrent
66993-681OLANZAPINEolanzapinePrasco LaboratoriesANDACurrent
66993-682OLANZAPINEOlanzapinePrasco LaboratoriesANDACurrent
66993-682OLANZAPINEOlanzapinePrasco LaboratoriesANDACurrent
66993-682OLANZAPINEOlanzapinePrasco LaboratoriesANDACurrent
66993-682OLANZAPINEOlanzapinePrasco LaboratoriesANDACurrent
66993-683OLANZAPINEOlanzapinePrasco LaboratoriesANDACurrent
66993-683OLANZAPINEOlanzapinePrasco LaboratoriesANDACurrent
66993-683OLANZAPINEOlanzapinePrasco LaboratoriesANDACurrent
66993-683OLANZAPINEOlanzapinePrasco LaboratoriesANDACurrent
66993-684OLANZAPINEOlanzapinePrasco LaboratoriesANDACurrent
66993-684OLANZAPINEOlanzapinePrasco LaboratoriesANDACurrent
66993-684OLANZAPINEOlanzapinePrasco LaboratoriesANDACurrent
66993-684OLANZAPINEOlanzapinePrasco LaboratoriesANDACurrent
66993-685OLANZAPINEOlanzapinePrasco LaboratoriesANDACurrent
66993-685OLANZAPINEOlanzapinePrasco LaboratoriesANDACurrent
66993-685OLANZAPINEOlanzapinePrasco LaboratoriesANDACurrent
66993-685OLANZAPINEOlanzapinePrasco LaboratoriesANDACurrent
68788-8185OlanzapineOlanzapinePreferred Pharmaceuticals Inc.ANDACurrent
70518-2158OlanzapineOlanzapineREMEDYREPACK INC.ANDACurrent
70518-2158OlanzapineOlanzapineREMEDYREPACK INC.ANDACurrent
70518-2891OLANZAPINEolanzapineREMEDYREPACK INC.ANDACurrent
70518-2891OLANZAPINEolanzapineREMEDYREPACK INC.ANDACurrent
70518-3054OLANZAPINEOlanzapineREMEDYREPACK INC.ANDACurrent
71335-1936OlanzapineOlanzapineBryant Ranch PrepackANDACurrent