Home Applications 078901 Application 078901
Type ANDA
Sponsor SANDOZ Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 OLANZAPINE AND FLUOXETINE HYDROCHLORIDE FLUOXETINE HYDROCHLORIDE; OLANZAPINE CAPSULE;ORAL EQ 25MG BASE;EQ 6MG BASE No No 002 OLANZAPINE AND FLUOXETINE HYDROCHLORIDE FLUOXETINE HYDROCHLORIDE; OLANZAPINE CAPSULE;ORAL EQ 50MG BASE;EQ 6MG BASE No No 003 OLANZAPINE AND FLUOXETINE HYDROCHLORIDE FLUOXETINE HYDROCHLORIDE; OLANZAPINE CAPSULE;ORAL EQ 25MG BASE;EQ 12MG BASE No No 004 OLANZAPINE AND FLUOXETINE HYDROCHLORIDE FLUOXETINE HYDROCHLORIDE; OLANZAPINE CAPSULE;ORAL EQ 50MG BASE;EQ 12MG BASE No No 005 OLANZAPINE AND FLUOXETINE HYDROCHLORIDE FLUOXETINE HYDROCHLORIDE; OLANZAPINE CAPSULE;ORAL EQ 25MG BASE;EQ 3MG BASE No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
Orange Book products# Current product rows page 1 of 1 · 5 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A078901-001 OLANZAPINE AND FLUOXETINE HYDROCHLORIDE FLUOXETINE HYDROCHLORIDE; OLANZAPINE EQ 25MG BASE;EQ 6MG BASE CAPSULE / ORAL AB 2012-11-16 A078901-002 OLANZAPINE AND FLUOXETINE HYDROCHLORIDE FLUOXETINE HYDROCHLORIDE; OLANZAPINE EQ 50MG BASE;EQ 6MG BASE CAPSULE / ORAL AB 2012-11-16 A078901-003 OLANZAPINE AND FLUOXETINE HYDROCHLORIDE FLUOXETINE HYDROCHLORIDE; OLANZAPINE EQ 25MG BASE;EQ 12MG BASE CAPSULE / ORAL AB 2012-11-16 A078901-004 OLANZAPINE AND FLUOXETINE HYDROCHLORIDE FLUOXETINE HYDROCHLORIDE; OLANZAPINE EQ 50MG BASE;EQ 12MG BASE CAPSULE / ORAL AB 2012-11-16 A078901-005 OLANZAPINE AND FLUOXETINE HYDROCHLORIDE FLUOXETINE HYDROCHLORIDE; OLANZAPINE EQ 25MG BASE;EQ 3MG BASE CAPSULE / ORAL AB 2012-11-16
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 5 matching rows.
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 6 of 6 · 220 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2022-10-28 04:53 UTC 2022-10 A078901-001 OLANZAPINE AND FLUOXETINE HYDROCHLORIDE EQ 25MG BASE;EQ 6MG BASE CAPSULE / ORAL AB 2012-11-16 f41ea6bd6efb…2022-10-28 04:53 UTC 2022-10 A078901-002 OLANZAPINE AND FLUOXETINE HYDROCHLORIDE EQ 50MG BASE;EQ 6MG BASE CAPSULE / ORAL AB 2012-11-16 f41ea6bd6efb…2022-10-28 04:53 UTC 2022-10 A078901-003 OLANZAPINE AND FLUOXETINE HYDROCHLORIDE EQ 25MG BASE;EQ 12MG BASE CAPSULE / ORAL AB 2012-11-16 f41ea6bd6efb…2022-10-28 04:53 UTC 2022-10 A078901-004 OLANZAPINE AND FLUOXETINE HYDROCHLORIDE EQ 50MG BASE;EQ 12MG BASE CAPSULE / ORAL AB 2012-11-16 f41ea6bd6efb…2022-10-28 04:53 UTC 2022-10 A078901-005 OLANZAPINE AND FLUOXETINE HYDROCHLORIDE EQ 25MG BASE;EQ 3MG BASE CAPSULE / ORAL AB 2012-11-16 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A078901-001 OLANZAPINE AND FLUOXETINE HYDROCHLORIDE EQ 25MG BASE;EQ 6MG BASE CAPSULE / ORAL AB 2012-11-16 e64feba35796…2022-09-29 23:25 UTC 2022-09 A078901-002 OLANZAPINE AND FLUOXETINE HYDROCHLORIDE EQ 50MG BASE;EQ 6MG BASE CAPSULE / ORAL AB 2012-11-16 e64feba35796…2022-09-29 23:25 UTC 2022-09 A078901-003 OLANZAPINE AND FLUOXETINE HYDROCHLORIDE EQ 25MG BASE;EQ 12MG BASE CAPSULE / ORAL AB 2012-11-16 e64feba35796…2022-09-29 23:25 UTC 2022-09 A078901-004 OLANZAPINE AND FLUOXETINE HYDROCHLORIDE EQ 50MG BASE;EQ 12MG BASE CAPSULE / ORAL AB 2012-11-16 e64feba35796…2022-09-29 23:25 UTC 2022-09 A078901-005 OLANZAPINE AND FLUOXETINE HYDROCHLORIDE EQ 25MG BASE;EQ 3MG BASE CAPSULE / ORAL AB 2012-11-16 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A078901-001 OLANZAPINE AND FLUOXETINE HYDROCHLORIDE EQ 25MG BASE;EQ 6MG BASE CAPSULE / ORAL AB 2012-11-16 cb3db0bc1861…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A078901-002 OLANZAPINE AND FLUOXETINE HYDROCHLORIDE EQ 50MG BASE;EQ 6MG BASE CAPSULE / ORAL AB 2012-11-16 cb3db0bc1861…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A078901-003 OLANZAPINE AND FLUOXETINE HYDROCHLORIDE EQ 25MG BASE;EQ 12MG BASE CAPSULE / ORAL AB 2012-11-16 cb3db0bc1861…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A078901-004 OLANZAPINE AND FLUOXETINE HYDROCHLORIDE EQ 50MG BASE;EQ 12MG BASE CAPSULE / ORAL AB 2012-11-16 cb3db0bc1861…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A078901-005 OLANZAPINE AND FLUOXETINE HYDROCHLORIDE EQ 25MG BASE;EQ 3MG BASE CAPSULE / ORAL AB 2012-11-16 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A078901-001 OLANZAPINE AND FLUOXETINE HYDROCHLORIDE EQ 25MG BASE;EQ 6MG BASE CAPSULE / ORAL AB 2012-11-16 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A078901-002 OLANZAPINE AND FLUOXETINE HYDROCHLORIDE EQ 50MG BASE;EQ 6MG BASE CAPSULE / ORAL AB 2012-11-16 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A078901-003 OLANZAPINE AND FLUOXETINE HYDROCHLORIDE EQ 25MG BASE;EQ 12MG BASE CAPSULE / ORAL AB 2012-11-16 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A078901-004 OLANZAPINE AND FLUOXETINE HYDROCHLORIDE EQ 50MG BASE;EQ 12MG BASE CAPSULE / ORAL AB 2012-11-16 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A078901-005 OLANZAPINE AND FLUOXETINE HYDROCHLORIDE EQ 25MG BASE;EQ 3MG BASE CAPSULE / ORAL AB 2012-11-16 a50c72e98297…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 6 · 220 observed states.
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 · 15 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0781-2191 Olanzapine and Fluoxetine Olanzapine and Fluoxetine Sandoz Inc ANDA Current 0781-2191 Olanzapine and Fluoxetine Olanzapine and Fluoxetine Sandoz Inc ANDA Current 0781-2191 Olanzapine and Fluoxetine Olanzapine and Fluoxetine Sandoz Inc ANDA Current 0781-2192 Olanzapine and Fluoxetine Olanzapine and Fluoxetine Sandoz Inc ANDA Current 0781-2192 Olanzapine and Fluoxetine Olanzapine and Fluoxetine Sandoz Inc ANDA Current 0781-2192 Olanzapine and Fluoxetine Olanzapine and Fluoxetine Sandoz Inc ANDA Current 0781-2193 Olanzapine and Fluoxetine Olanzapine and Fluoxetine Sandoz Inc ANDA Current 0781-2193 Olanzapine and Fluoxetine Olanzapine and Fluoxetine Sandoz Inc ANDA Current 0781-2193 Olanzapine and Fluoxetine Olanzapine and Fluoxetine Sandoz Inc ANDA Current 0781-2194 Olanzapine and Fluoxetine Olanzapine and Fluoxetine Sandoz Inc ANDA Current 0781-2194 Olanzapine and Fluoxetine Olanzapine and Fluoxetine Sandoz Inc ANDA Current 0781-2194 Olanzapine and Fluoxetine Olanzapine and Fluoxetine Sandoz Inc ANDA Current 0781-2195 Olanzapine and Fluoxetine Olanzapine and Fluoxetine Sandoz Inc ANDA Current 0781-2195 Olanzapine and Fluoxetine Olanzapine and Fluoxetine Sandoz Inc ANDA Current 0781-2195 Olanzapine and Fluoxetine Olanzapine and Fluoxetine Sandoz Inc ANDA Current
Documents# Document, Submission type, Date table Document Submission type Date 9194 ORIG 2012-12-18