Application 077742

Type
ANDA
Sponsor
PAR PHARM

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001OLANZAPINE AND FLUOXETINE HYDROCHLORIDEFLUOXETINE HYDROCHLORIDE; OLANZAPINECAPSULE;ORALEQ 25MG BASE;EQ 3MG BASENoNo
002OLANZAPINE AND FLUOXETINE HYDROCHLORIDEFLUOXETINE HYDROCHLORIDE; OLANZAPINECAPSULE;ORALEQ 25MG BASE;EQ 6MG BASENoNo
003OLANZAPINE AND FLUOXETINE HYDROCHLORIDEFLUOXETINE HYDROCHLORIDE; OLANZAPINECAPSULE;ORALEQ 25MG BASE;EQ 12MG BASENoNo
004OLANZAPINE AND FLUOXETINE HYDROCHLORIDEFLUOXETINE HYDROCHLORIDE; OLANZAPINECAPSULE;ORALEQ 50MG BASE;EQ 6MG BASENoNo
005OLANZAPINE AND FLUOXETINE HYDROCHLORIDEFLUOXETINE HYDROCHLORIDE; OLANZAPINECAPSULE;ORALEQ 50MG BASE;EQ 12MG BASENoNo

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

Orange Book products#

Current product rows page 1 of 1 · 5 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A077742-001OLANZAPINE AND FLUOXETINE HYDROCHLORIDEFLUOXETINE HYDROCHLORIDE; OLANZAPINEEQ 25MG BASE;EQ 3MG BASECAPSULE / ORALAB2012-11-02
A077742-002OLANZAPINE AND FLUOXETINE HYDROCHLORIDEFLUOXETINE HYDROCHLORIDE; OLANZAPINEEQ 25MG BASE;EQ 6MG BASECAPSULE / ORALAB2012-11-02
A077742-003OLANZAPINE AND FLUOXETINE HYDROCHLORIDEFLUOXETINE HYDROCHLORIDE; OLANZAPINEEQ 25MG BASE;EQ 12MG BASECAPSULE / ORALAB2012-11-02
A077742-004OLANZAPINE AND FLUOXETINE HYDROCHLORIDEFLUOXETINE HYDROCHLORIDE; OLANZAPINEEQ 50MG BASE;EQ 6MG BASECAPSULE / ORALAB2012-11-02
A077742-005OLANZAPINE AND FLUOXETINE HYDROCHLORIDEFLUOXETINE HYDROCHLORIDE; OLANZAPINEEQ 50MG BASE;EQ 12MG BASECAPSULE / ORALAB2012-11-02

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 5 matching rows.

Application-product, TE code table
Application-productTE code
A077742-001AB
A077742-002AB
A077742-003AB
A077742-004AB
A077742-005AB

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 6 · 215 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A077742-001OLANZAPINE AND FLUOXETINE HYDROCHLORIDEEQ 25MG BASE;EQ 3MG BASECAPSULE / ORALAB2012-11-0284e616aacf4f…
2026-09-14 22:38:342026-08A077742-002OLANZAPINE AND FLUOXETINE HYDROCHLORIDEEQ 25MG BASE;EQ 6MG BASECAPSULE / ORALAB2012-11-0284e616aacf4f…
2026-09-14 22:38:342026-08A077742-003OLANZAPINE AND FLUOXETINE HYDROCHLORIDEEQ 25MG BASE;EQ 12MG BASECAPSULE / ORALAB2012-11-0284e616aacf4f…
2026-09-14 22:38:342026-08A077742-004OLANZAPINE AND FLUOXETINE HYDROCHLORIDEEQ 50MG BASE;EQ 6MG BASECAPSULE / ORALAB2012-11-0284e616aacf4f…
2026-09-14 22:38:342026-08A077742-005OLANZAPINE AND FLUOXETINE HYDROCHLORIDEEQ 50MG BASE;EQ 12MG BASECAPSULE / ORALAB2012-11-0284e616aacf4f…
2026-08-18 06:07:402026-07A077742-001OLANZAPINE AND FLUOXETINE HYDROCHLORIDEEQ 25MG BASE;EQ 3MG BASECAPSULE / ORALAB2012-11-02caaa826d4ba7…
2026-08-18 06:07:402026-07A077742-002OLANZAPINE AND FLUOXETINE HYDROCHLORIDEEQ 25MG BASE;EQ 6MG BASECAPSULE / ORALAB2012-11-02caaa826d4ba7…
2026-08-18 06:07:402026-07A077742-003OLANZAPINE AND FLUOXETINE HYDROCHLORIDEEQ 25MG BASE;EQ 12MG BASECAPSULE / ORALAB2012-11-02caaa826d4ba7…
2026-08-18 06:07:402026-07A077742-004OLANZAPINE AND FLUOXETINE HYDROCHLORIDEEQ 50MG BASE;EQ 6MG BASECAPSULE / ORALAB2012-11-02caaa826d4ba7…
2026-08-18 06:07:402026-07A077742-005OLANZAPINE AND FLUOXETINE HYDROCHLORIDEEQ 50MG BASE;EQ 12MG BASECAPSULE / ORALAB2012-11-02caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A077742-001OLANZAPINE AND FLUOXETINE HYDROCHLORIDEEQ 25MG BASE;EQ 3MG BASECAPSULE / ORALAB2012-11-02011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077742-002OLANZAPINE AND FLUOXETINE HYDROCHLORIDEEQ 25MG BASE;EQ 6MG BASECAPSULE / ORALAB2012-11-02011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077742-003OLANZAPINE AND FLUOXETINE HYDROCHLORIDEEQ 25MG BASE;EQ 12MG BASECAPSULE / ORALAB2012-11-02011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077742-004OLANZAPINE AND FLUOXETINE HYDROCHLORIDEEQ 50MG BASE;EQ 6MG BASECAPSULE / ORALAB2012-11-02011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077742-005OLANZAPINE AND FLUOXETINE HYDROCHLORIDEEQ 50MG BASE;EQ 12MG BASECAPSULE / ORALAB2012-11-02011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077742-001OLANZAPINE AND FLUOXETINE HYDROCHLORIDEEQ 25MG BASE;EQ 3MG BASECAPSULE / ORALAB2012-11-0231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077742-002OLANZAPINE AND FLUOXETINE HYDROCHLORIDEEQ 25MG BASE;EQ 6MG BASECAPSULE / ORALAB2012-11-0231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077742-003OLANZAPINE AND FLUOXETINE HYDROCHLORIDEEQ 25MG BASE;EQ 12MG BASECAPSULE / ORALAB2012-11-0231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077742-004OLANZAPINE AND FLUOXETINE HYDROCHLORIDEEQ 50MG BASE;EQ 6MG BASECAPSULE / ORALAB2012-11-0231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077742-005OLANZAPINE AND FLUOXETINE HYDROCHLORIDEEQ 50MG BASE;EQ 12MG BASECAPSULE / ORALAB2012-11-0231067a03dcf5…
2025-08-23 18:47 UTC2025-08A077742-001OLANZAPINE AND FLUOXETINE HYDROCHLORIDEEQ 25MG BASE;EQ 3MG BASECAPSULE / ORALAB2012-11-026a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077742-002OLANZAPINE AND FLUOXETINE HYDROCHLORIDEEQ 25MG BASE;EQ 6MG BASECAPSULE / ORALAB2012-11-026a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077742-003OLANZAPINE AND FLUOXETINE HYDROCHLORIDEEQ 25MG BASE;EQ 12MG BASECAPSULE / ORALAB2012-11-026a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077742-004OLANZAPINE AND FLUOXETINE HYDROCHLORIDEEQ 50MG BASE;EQ 6MG BASECAPSULE / ORALAB2012-11-026a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077742-005OLANZAPINE AND FLUOXETINE HYDROCHLORIDEEQ 50MG BASE;EQ 12MG BASECAPSULE / ORALAB2012-11-026a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077742-001OLANZAPINE AND FLUOXETINE HYDROCHLORIDEEQ 25MG BASE;EQ 3MG BASECAPSULE / ORALAB2012-11-02fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077742-002OLANZAPINE AND FLUOXETINE HYDROCHLORIDEEQ 25MG BASE;EQ 6MG BASECAPSULE / ORALAB2012-11-02fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077742-003OLANZAPINE AND FLUOXETINE HYDROCHLORIDEEQ 25MG BASE;EQ 12MG BASECAPSULE / ORALAB2012-11-02fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077742-004OLANZAPINE AND FLUOXETINE HYDROCHLORIDEEQ 50MG BASE;EQ 6MG BASECAPSULE / ORALAB2012-11-02fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077742-005OLANZAPINE AND FLUOXETINE HYDROCHLORIDEEQ 50MG BASE;EQ 12MG BASECAPSULE / ORALAB2012-11-02fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077742-001OLANZAPINE AND FLUOXETINE HYDROCHLORIDEEQ 25MG BASE;EQ 3MG BASECAPSULE / ORALAB2012-11-02b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077742-002OLANZAPINE AND FLUOXETINE HYDROCHLORIDEEQ 25MG BASE;EQ 6MG BASECAPSULE / ORALAB2012-11-02b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077742-003OLANZAPINE AND FLUOXETINE HYDROCHLORIDEEQ 25MG BASE;EQ 12MG BASECAPSULE / ORALAB2012-11-02b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077742-004OLANZAPINE AND FLUOXETINE HYDROCHLORIDEEQ 50MG BASE;EQ 6MG BASECAPSULE / ORALAB2012-11-02b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077742-005OLANZAPINE AND FLUOXETINE HYDROCHLORIDEEQ 50MG BASE;EQ 12MG BASECAPSULE / ORALAB2012-11-02b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077742-001OLANZAPINE AND FLUOXETINE HYDROCHLORIDEEQ 25MG BASE;EQ 3MG BASECAPSULE / ORALAB2012-11-0203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077742-002OLANZAPINE AND FLUOXETINE HYDROCHLORIDEEQ 25MG BASE;EQ 6MG BASECAPSULE / ORALAB2012-11-0203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077742-003OLANZAPINE AND FLUOXETINE HYDROCHLORIDEEQ 25MG BASE;EQ 12MG BASECAPSULE / ORALAB2012-11-0203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077742-004OLANZAPINE AND FLUOXETINE HYDROCHLORIDEEQ 50MG BASE;EQ 6MG BASECAPSULE / ORALAB2012-11-0203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077742-005OLANZAPINE AND FLUOXETINE HYDROCHLORIDEEQ 50MG BASE;EQ 12MG BASECAPSULE / ORALAB2012-11-0203ed91905a0d…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 6 · 215 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A077742-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A077742-002AB184e616aacf4f…
2026-09-14 22:38:342026-08A077742-003AB184e616aacf4f…
2026-09-14 22:38:342026-08A077742-004AB184e616aacf4f…
2026-09-14 22:38:342026-08A077742-005AB184e616aacf4f…
2026-08-18 06:07:402026-07A077742-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A077742-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A077742-003AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A077742-004AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A077742-005AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A077742-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077742-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077742-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077742-004AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077742-005AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077742-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077742-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077742-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077742-004AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077742-005AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A077742-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077742-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077742-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077742-004AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077742-005AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077742-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077742-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077742-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077742-004AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077742-005AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077742-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077742-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077742-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077742-004AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077742-005AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077742-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077742-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077742-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077742-004AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077742-005AB103ed91905a0d…

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Olanzapine and FluoxetineOLANZAPINE AND FUOXETINEPar Health USA, LLC2f6ceda3-3edc-4427-98a6-23e3c930c44d2025-12-10Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077742
application number: ANDA077742
ndc (product): 49884-277
ndc (product): 49884-250
ndc (product): 49884-251
ndc (product): 49884-253
ndc (product): 49884-252

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 · 25 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
49884-250Olanzapine and Fluoxetineolanzapine and fuoxetinePar Pharmaceutical, Inc.ANDACurrent
49884-250Olanzapine and Fluoxetineolanzapine and fuoxetinePar Pharmaceutical, Inc.ANDACurrent
49884-250Olanzapine and Fluoxetineolanzapine and fuoxetinePar Pharmaceutical, Inc.ANDACurrent
49884-250Olanzapine and Fluoxetineolanzapine and fuoxetinePar Pharmaceutical, Inc.ANDACurrent
49884-250Olanzapine and Fluoxetineolanzapine and fuoxetinePar Pharmaceutical, Inc.ANDACurrent
49884-251Olanzapine and Fluoxetineolanzapine and fuoxetinePar Pharmaceutical, Inc.ANDACurrent
49884-251Olanzapine and Fluoxetineolanzapine and fuoxetinePar Pharmaceutical, Inc.ANDACurrent
49884-251Olanzapine and Fluoxetineolanzapine and fuoxetinePar Pharmaceutical, Inc.ANDACurrent
49884-251Olanzapine and Fluoxetineolanzapine and fuoxetinePar Pharmaceutical, Inc.ANDACurrent
49884-251Olanzapine and Fluoxetineolanzapine and fuoxetinePar Pharmaceutical, Inc.ANDACurrent
49884-252Olanzapine and Fluoxetineolanzapine and fuoxetinePar Pharmaceutical, Inc.ANDACurrent
49884-252Olanzapine and Fluoxetineolanzapine and fuoxetinePar Pharmaceutical, Inc.ANDACurrent
49884-252Olanzapine and Fluoxetineolanzapine and fuoxetinePar Pharmaceutical, Inc.ANDACurrent
49884-252Olanzapine and Fluoxetineolanzapine and fuoxetinePar Pharmaceutical, Inc.ANDACurrent
49884-252Olanzapine and Fluoxetineolanzapine and fuoxetinePar Pharmaceutical, Inc.ANDACurrent
49884-253Olanzapine and Fluoxetineolanzapine and fuoxetinePar Pharmaceutical, Inc.ANDACurrent
49884-253Olanzapine and Fluoxetineolanzapine and fuoxetinePar Pharmaceutical, Inc.ANDACurrent
49884-253Olanzapine and Fluoxetineolanzapine and fuoxetinePar Pharmaceutical, Inc.ANDACurrent
49884-253Olanzapine and Fluoxetineolanzapine and fuoxetinePar Pharmaceutical, Inc.ANDACurrent
49884-253Olanzapine and Fluoxetineolanzapine and fuoxetinePar Pharmaceutical, Inc.ANDACurrent
49884-277Olanzapine and Fluoxetineolanzapine and fuoxetinePar Pharmaceutical, Inc.ANDACurrent
49884-277Olanzapine and Fluoxetineolanzapine and fuoxetinePar Pharmaceutical, Inc.ANDACurrent
49884-277Olanzapine and Fluoxetineolanzapine and fuoxetinePar Pharmaceutical, Inc.ANDACurrent
49884-277Olanzapine and Fluoxetineolanzapine and fuoxetinePar Pharmaceutical, Inc.ANDACurrent
49884-277Olanzapine and Fluoxetineolanzapine and fuoxetinePar Pharmaceutical, Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
22611ORIG2013-01-22
31285ORIG2012-12-18