Home Applications 077629 Application 077629
Type ANDA
Sponsor LANNETT CO INC Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 CITALOPRAM HYDROBROMIDE CITALOPRAM HYDROBROMIDE SOLUTION;ORAL EQ 10MG 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 A077629-001 CITALOPRAM HYDROBROMIDE CITALOPRAM HYDROBROMIDE EQ 10MG BASE/5ML SOLUTION / ORAL AA 2006-06-14
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A077629-001 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 A077629-001 CITALOPRAM HYDROBROMIDE EQ 10MG BASE/5ML SOLUTION / ORAL AA 2006-06-14 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077629-001 CITALOPRAM HYDROBROMIDE EQ 10MG BASE/5ML SOLUTION / ORAL AA 2006-06-14 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A077629-001 CITALOPRAM HYDROBROMIDE EQ 10MG BASE/5ML SOLUTION / ORAL AA 2006-06-14 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077629-001 CITALOPRAM HYDROBROMIDE EQ 10MG BASE/5ML SOLUTION / ORAL AA 2006-06-14 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077629-001 CITALOPRAM HYDROBROMIDE EQ 10MG BASE/5ML SOLUTION / ORAL AA 2006-06-14 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077629-001 CITALOPRAM HYDROBROMIDE EQ 10MG BASE/5ML SOLUTION / ORAL AA 2006-06-14 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077629-001 CITALOPRAM HYDROBROMIDE EQ 10MG BASE/5ML SOLUTION / ORAL AA 2006-06-14 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077629-001 CITALOPRAM HYDROBROMIDE EQ 10MG BASE/5ML SOLUTION / ORAL AA 2006-06-14 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077629-001 CITALOPRAM HYDROBROMIDE EQ 10MG BASE/5ML SOLUTION / ORAL AA 2006-06-14 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A077629-001 CITALOPRAM HYDROBROMIDE EQ 10MG BASE/5ML SOLUTION / ORAL AA 2006-06-14 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A077629-001 CITALOPRAM HYDROBROMIDE EQ 10MG BASE/5ML SOLUTION / ORAL AA 2006-06-14 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A077629-001 CITALOPRAM HYDROBROMIDE EQ 10MG BASE/5ML SOLUTION / ORAL AA 2006-06-14 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A077629-001 CITALOPRAM HYDROBROMIDE EQ 10MG BASE/5ML SOLUTION / ORAL AA 2006-06-14 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A077629-001 CITALOPRAM HYDROBROMIDE EQ 10MG BASE/5ML SOLUTION / ORAL AA 2006-06-14 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A077629-001 CITALOPRAM HYDROBROMIDE EQ 10MG BASE/5ML SOLUTION / ORAL AA 2006-06-15 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A077629-001 CITALOPRAM HYDROBROMIDE EQ 10MG BASE/5ML SOLUTION / ORAL AA 2006-06-15 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A077629-001 CITALOPRAM HYDROBROMIDE EQ 10MG BASE/5ML SOLUTION / ORAL AA 2006-06-15 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A077629-001 CITALOPRAM HYDROBROMIDE EQ 10MG BASE/5ML SOLUTION / ORAL AA 2006-06-15 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A077629-001 CITALOPRAM HYDROBROMIDE EQ 10MG BASE/5ML SOLUTION / ORAL AA 2006-06-15 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A077629-001 CITALOPRAM HYDROBROMIDE EQ 10MG BASE/5ML SOLUTION / ORAL AA 2006-06-15 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A077629-001 CITALOPRAM HYDROBROMIDE EQ 10MG BASE/5ML SOLUTION / ORAL AA 2006-06-15 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A077629-001 CITALOPRAM HYDROBROMIDE EQ 10MG BASE/5ML SOLUTION / ORAL AA 2006-06-15 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A077629-001 CITALOPRAM HYDROBROMIDE EQ 10MG BASE/5ML SOLUTION / ORAL AA 2006-06-15 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A077629-001 CITALOPRAM HYDROBROMIDE EQ 10MG BASE/5ML SOLUTION / ORAL AA 2006-06-15 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A077629-001 CITALOPRAM HYDROBROMIDE EQ 10MG BASE/5ML SOLUTION / ORAL AA 2006-06-15 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A077629-001 CITALOPRAM HYDROBROMIDE EQ 10MG BASE/5ML SOLUTION / ORAL AA 2006-06-15 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A077629-001 CITALOPRAM HYDROBROMIDE EQ 10MG BASE/5ML SOLUTION / ORAL AA 2006-06-15 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A077629-001 CITALOPRAM HYDROBROMIDE EQ 10MG BASE/5ML SOLUTION / ORAL AA 2006-06-14 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A077629-001 CITALOPRAM HYDROBROMIDE EQ 10MG BASE/5ML SOLUTION / ORAL AA 2006-06-14 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A077629-001 CITALOPRAM HYDROBROMIDE EQ 10MG BASE/5ML SOLUTION / ORAL AA 2006-06-14 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A077629-001 CITALOPRAM HYDROBROMIDE EQ 10MG BASE/5ML SOLUTION / ORAL AA 2006-06-14 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A077629-001 CITALOPRAM HYDROBROMIDE EQ 10MG BASE/5ML SOLUTION / ORAL AA 2006-06-14 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A077629-001 CITALOPRAM HYDROBROMIDE EQ 10MG BASE/5ML SOLUTION / ORAL AA 2006-06-14 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A077629-001 CITALOPRAM HYDROBROMIDE EQ 10MG BASE/5ML SOLUTION / ORAL AA 2006-06-14 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A077629-001 CITALOPRAM HYDROBROMIDE EQ 10MG BASE/5ML SOLUTION / ORAL AA 2006-06-14 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A077629-001 CITALOPRAM HYDROBROMIDE EQ 10MG BASE/5ML SOLUTION / ORAL AA 2006-06-14 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A077629-001 CITALOPRAM HYDROBROMIDE EQ 10MG BASE/5ML SOLUTION / ORAL AA 2006-06-15 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A077629-001 CITALOPRAM HYDROBROMIDE EQ 10MG BASE/5ML SOLUTION / ORAL AA 2006-06-15 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A077629-001 CITALOPRAM HYDROBROMIDE EQ 10MG BASE/5ML SOLUTION / ORAL AA 2006-06-15 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A077629-001 CITALOPRAM HYDROBROMIDE EQ 10MG BASE/5ML SOLUTION / ORAL AA 2006-06-15 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 · 2 matching rows.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 9 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0121-0848 Citalopram Citalopram Hydrobromide Pharmaceutical Associates, Inc. ANDA Current 0121-1696 Citalopram Citalopram Hydrobromide Pharmaceutical Associates, Inc. ANDA Current 17856-0540 Citalopram Hydrobromide Citalopram Hydrobromide Atlantic Biologicals Corps ANDA Current 54838-540 Citalopram Hydrobromide Citalopram Hydrobromide Lannett Company, Inc. ANDA Current 54838-540 Citalopram Hydrobromide Citalopram Hydrobromide Lannett Company, Inc. ANDA Current 54838-540 Citalopram Hydrobromide Citalopram Hydrobromide Lannett Company, Inc. ANDA Current 54838-540 Citalopram Hydrobromide Citalopram Hydrobromide Lannett Company, Inc. ANDA Current 54838-540 Citalopram Hydrobromide Citalopram Hydrobromide Lannett Company, Inc. ANDA Current 62135-540 Citalopram Citalopram Chartwell RX, LLC ANDA Current
Documents# Document, Submission type, Date table Document Submission type Date 44361 ORIG 2006-06-19