Home Applications 077849 Application 077849
Type ANDA
Sponsor LANNETT CO INC Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 FLUOXETINE HYDROCHLORIDE FLUOXETINE HYDROCHLORIDE SOLUTION;ORAL EQ 20MG BASE/5ML No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A077849-001 FLUOXETINE HYDROCHLORIDE FLUOXETINE HYDROCHLORIDE EQ 20MG BASE/5ML SOLUTION / ORAL AA 2007-02-09
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A077849-001 AA
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 2 · 41 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 2026-02-19 14:30 UTC 2026-02 A077849-001 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE/5ML SOLUTION / ORAL AA 2007-02-09 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077849-001 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE/5ML SOLUTION / ORAL AA 2007-02-09 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A077849-001 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE/5ML SOLUTION / ORAL AA 2007-02-09 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077849-001 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE/5ML SOLUTION / ORAL AA 2007-02-09 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077849-001 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE/5ML SOLUTION / ORAL AA 2007-02-09 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077849-001 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE/5ML SOLUTION / ORAL AA 2007-02-09 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077849-001 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE/5ML SOLUTION / ORAL AA 2007-02-09 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077849-001 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE/5ML SOLUTION / ORAL AA 2007-02-09 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077849-001 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE/5ML SOLUTION / ORAL AA 2007-02-09 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A077849-001 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE/5ML SOLUTION / ORAL AA 2007-02-09 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A077849-001 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE/5ML SOLUTION / ORAL AA 2007-02-09 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A077849-001 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE/5ML SOLUTION / ORAL AA 2007-02-09 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A077849-001 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE/5ML SOLUTION / ORAL AA 2007-02-09 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A077849-001 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE/5ML SOLUTION / ORAL AA 2007-02-09 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A077849-001 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE/5ML SOLUTION / ORAL AA 2007-02-09 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A077849-001 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE/5ML SOLUTION / ORAL AA 2007-02-09 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A077849-001 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE/5ML SOLUTION / ORAL AA 2007-02-09 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A077849-001 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE/5ML SOLUTION / ORAL AA 2007-02-09 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A077849-001 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE/5ML SOLUTION / ORAL AA 2007-02-09 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A077849-001 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE/5ML SOLUTION / ORAL AA 2007-02-09 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A077849-001 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE/5ML SOLUTION / ORAL AA 2007-02-09 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A077849-001 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE/5ML SOLUTION / ORAL AA 2007-02-09 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A077849-001 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE/5ML SOLUTION / ORAL AA 2007-02-09 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A077849-001 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE/5ML SOLUTION / ORAL AA 2007-02-09 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A077849-001 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE/5ML SOLUTION / ORAL AA 2007-02-09 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A077849-001 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE/5ML SOLUTION / ORAL AA 2007-02-09 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A077849-001 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE/5ML SOLUTION / ORAL AA 2007-02-09 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A077849-001 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE/5ML SOLUTION / ORAL AA 2007-02-09 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A077849-001 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE/5ML SOLUTION / ORAL AA 2007-02-09 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A077849-001 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE/5ML SOLUTION / ORAL AA 2007-02-09 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A077849-001 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE/5ML SOLUTION / ORAL AA 2007-02-09 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A077849-001 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE/5ML SOLUTION / ORAL AA 2007-02-09 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A077849-001 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE/5ML SOLUTION / ORAL AA 2007-02-09 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A077849-001 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE/5ML SOLUTION / ORAL AA 2007-02-09 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A077849-001 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE/5ML SOLUTION / ORAL AA 2007-02-09 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A077849-001 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE/5ML SOLUTION / ORAL AA 2007-02-09 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A077849-001 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE/5ML SOLUTION / ORAL AA 2007-02-09 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A077849-001 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE/5ML SOLUTION / ORAL AA 2007-02-09 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A077849-001 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE/5ML SOLUTION / ORAL AA 2007-02-09 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A077849-001 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE/5ML SOLUTION / ORAL AA 2007-02-09 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
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 Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Fluoxetine FLUOXETINE HYDROCHLORIDE Lannett Company, Inc. c856d72f-4a1a-4f75-ae54-c4ac83ddcfa1 2023-08-28 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 077849 application number: ANDA077849 ndc (product): 54838-523
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 8 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 54838-523 Fluoxetine Fluoxetine Hydrochloride Lannett Company, Inc. ANDA Current 54838-523 Fluoxetine Fluoxetine Hydrochloride Lannett Company, Inc. ANDA Current 54838-523 Fluoxetine Fluoxetine Hydrochloride Lannett Company, Inc. ANDA Current 54838-523 Fluoxetine Fluoxetine Hydrochloride Lannett Company, Inc. ANDA Current 60687-244 Fluoxetine Fluoxetine Hydrochloride American Health Packaging ANDA Current 60687-244 Fluoxetine Fluoxetine Hydrochloride American Health Packaging ANDA Current 60687-244 Fluoxetine Fluoxetine Hydrochloride American Health Packaging ANDA Current 60687-244 Fluoxetine Fluoxetine Hydrochloride American Health Packaging ANDA Current