Home Applications 077038 Application 077038
Type ANDA
Sponsor DR REDDYS LABS LTD Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 CITALOPRAM HYDROBROMIDE CITALOPRAM HYDROBROMIDE TABLET;ORAL EQ 10MG BASE No No 002 CITALOPRAM HYDROBROMIDE CITALOPRAM HYDROBROMIDE TABLET;ORAL EQ 20MG BASE No No 003 CITALOPRAM HYDROBROMIDE CITALOPRAM HYDROBROMIDE TABLET;ORAL EQ 40MG BASE No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
Orange Book products# Current product rows page 1 of 1 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A077038-001 CITALOPRAM HYDROBROMIDE CITALOPRAM HYDROBROMIDE EQ 10MG BASE TABLET / ORAL AB 2004-10-28 A077038-002 CITALOPRAM HYDROBROMIDE CITALOPRAM HYDROBROMIDE EQ 20MG BASE TABLET / ORAL AB 2004-10-28 A077038-003 CITALOPRAM HYDROBROMIDE CITALOPRAM HYDROBROMIDE EQ 40MG BASE TABLET / ORAL AB 2004-10-28
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 3 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 1 of 4 · 129 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 2026-09-14 22:38:34 2026-08 A077038-001 CITALOPRAM HYDROBROMIDE EQ 10MG BASE TABLET / ORAL AB 2004-10-28 84e616aacf4f…2026-09-14 22:38:34 2026-08 A077038-002 CITALOPRAM HYDROBROMIDE EQ 20MG BASE TABLET / ORAL AB 2004-10-28 84e616aacf4f…2026-09-14 22:38:34 2026-08 A077038-003 CITALOPRAM HYDROBROMIDE EQ 40MG BASE TABLET / ORAL AB 2004-10-28 84e616aacf4f…2026-08-18 06:07:40 2026-07 A077038-001 CITALOPRAM HYDROBROMIDE EQ 10MG BASE TABLET / ORAL AB 2004-10-28 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A077038-002 CITALOPRAM HYDROBROMIDE EQ 20MG BASE TABLET / ORAL AB 2004-10-28 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A077038-003 CITALOPRAM HYDROBROMIDE EQ 40MG BASE TABLET / ORAL AB 2004-10-28 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A077038-001 CITALOPRAM HYDROBROMIDE EQ 10MG BASE TABLET / ORAL AB 2004-10-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A077038-002 CITALOPRAM HYDROBROMIDE EQ 20MG BASE TABLET / ORAL AB 2004-10-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A077038-003 CITALOPRAM HYDROBROMIDE EQ 40MG BASE TABLET / ORAL AB 2004-10-28 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077038-001 CITALOPRAM HYDROBROMIDE EQ 10MG BASE TABLET / ORAL AB 2004-10-28 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077038-002 CITALOPRAM HYDROBROMIDE EQ 20MG BASE TABLET / ORAL AB 2004-10-28 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077038-003 CITALOPRAM HYDROBROMIDE EQ 40MG BASE TABLET / ORAL AB 2004-10-28 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A077038-001 CITALOPRAM HYDROBROMIDE EQ 10MG BASE TABLET / ORAL AB 2004-10-28 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A077038-002 CITALOPRAM HYDROBROMIDE EQ 20MG BASE TABLET / ORAL AB 2004-10-28 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A077038-003 CITALOPRAM HYDROBROMIDE EQ 40MG BASE TABLET / ORAL AB 2004-10-28 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077038-001 CITALOPRAM HYDROBROMIDE EQ 10MG BASE TABLET / ORAL AB 2004-10-28 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077038-002 CITALOPRAM HYDROBROMIDE EQ 20MG BASE TABLET / ORAL AB 2004-10-28 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077038-003 CITALOPRAM HYDROBROMIDE EQ 40MG BASE TABLET / ORAL AB 2004-10-28 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077038-001 CITALOPRAM HYDROBROMIDE EQ 10MG BASE TABLET / ORAL AB 2004-10-28 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077038-002 CITALOPRAM HYDROBROMIDE EQ 20MG BASE TABLET / ORAL AB 2004-10-28 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077038-003 CITALOPRAM HYDROBROMIDE EQ 40MG BASE TABLET / ORAL AB 2004-10-28 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077038-001 CITALOPRAM HYDROBROMIDE EQ 10MG BASE TABLET / ORAL AB 2004-10-28 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077038-002 CITALOPRAM HYDROBROMIDE EQ 20MG BASE TABLET / ORAL AB 2004-10-28 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077038-003 CITALOPRAM HYDROBROMIDE EQ 40MG BASE TABLET / ORAL AB 2004-10-28 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077038-001 CITALOPRAM HYDROBROMIDE EQ 10MG BASE TABLET / ORAL AB 2004-10-28 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077038-002 CITALOPRAM HYDROBROMIDE EQ 20MG BASE TABLET / ORAL AB 2004-10-28 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077038-003 CITALOPRAM HYDROBROMIDE EQ 40MG BASE TABLET / ORAL AB 2004-10-28 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077038-001 CITALOPRAM HYDROBROMIDE EQ 10MG BASE TABLET / ORAL AB 2004-10-28 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077038-002 CITALOPRAM HYDROBROMIDE EQ 20MG BASE TABLET / ORAL AB 2004-10-28 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077038-003 CITALOPRAM HYDROBROMIDE EQ 40MG BASE TABLET / ORAL AB 2004-10-28 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077038-001 CITALOPRAM HYDROBROMIDE EQ 10MG BASE TABLET / ORAL AB 2004-10-28 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077038-002 CITALOPRAM HYDROBROMIDE EQ 20MG BASE TABLET / ORAL AB 2004-10-28 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077038-003 CITALOPRAM HYDROBROMIDE EQ 40MG BASE TABLET / ORAL AB 2004-10-28 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A077038-001 CITALOPRAM HYDROBROMIDE EQ 10MG BASE TABLET / ORAL AB 2004-10-28 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A077038-002 CITALOPRAM HYDROBROMIDE EQ 20MG BASE TABLET / ORAL AB 2004-10-28 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A077038-003 CITALOPRAM HYDROBROMIDE EQ 40MG BASE TABLET / ORAL AB 2004-10-28 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A077038-001 CITALOPRAM HYDROBROMIDE EQ 10MG BASE TABLET / ORAL AB 2004-10-28 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A077038-002 CITALOPRAM HYDROBROMIDE EQ 20MG BASE TABLET / ORAL AB 2004-10-28 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A077038-003 CITALOPRAM HYDROBROMIDE EQ 40MG BASE TABLET / ORAL AB 2004-10-28 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A077038-001 CITALOPRAM HYDROBROMIDE EQ 10MG BASE TABLET / ORAL AB 2004-10-28 301d65b070ca…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 129 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 3 of 3 · 43 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Citalopram CITALOPRAM HYDROBROMIDE Aphena Pharma Solutions - Tennessee, LLC 31ddd184-7560-473c-b674-5fa3187c5598 2020-04-24 Boxed warning, Warnings, Adverse reactions Name fallback generic name: CITALOPRAM HYDROBROMIDE Citalopram CITALOPRAM HYDROBROMIDE Proficient Rx LP 289c1d5e-902f-47db-85b8-5e1a55ec8684 2019-11-01 Boxed warning, Warnings, Adverse reactions Name fallback generic name: CITALOPRAM HYDROBROMIDE CITALOPRAM HYDROBROMIDE CITALOPRAM Aphena Pharma Solutions - Tennessee, LLC d05f4e71-95f3-4f22-8b01-b21e5c19e0f2 2018-07-16 Boxed warning, Warnings, Adverse reactions Name fallback brand name: CITALOPRAM HYDROBROMIDE
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 · 32 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 54458-889 CITALOPRAM CITALOPRAM International Laboratories, LLC ANDA Current 54458-889 CITALOPRAM CITALOPRAM International Laboratories, LLC ANDA Current 54458-980 CITALOPRAM CITALOPRAM International Laboratories, LLC ANDA Current 54458-980 CITALOPRAM CITALOPRAM International Laboratories, LLC ANDA Current 54458-981 CITALOPRAM CITALOPRAM International Laboratories, LLC ANDA Current 54458-981 CITALOPRAM CITALOPRAM International Laboratories, LLC ANDA Current 55111-342 Citalopram Hydrobromide Citalopram Hydrobromide Dr. Reddy's Laboratories Limited ANDA Current 55111-342 Citalopram Hydrobromide Citalopram Hydrobromide Dr. Reddy's Laboratories Limited ANDA Current 55111-342 Citalopram Hydrobromide Citalopram Hydrobromide Dr. Reddy's Laboratories Limited ANDA Current 55111-343 Citalopram Hydrobromide Citalopram Hydrobromide Dr. Reddy's Laboratories Limited ANDA Current 55111-343 Citalopram Hydrobromide Citalopram Hydrobromide Dr. Reddy's Laboratories Limited ANDA Current 55111-343 Citalopram Hydrobromide Citalopram Hydrobromide Dr. Reddy's Laboratories Limited ANDA Current 55111-344 Citalopram Hydrobromide Citalopram Hydrobromide Dr. Reddy's Laboratories Limited ANDA Current 55111-344 Citalopram Hydrobromide Citalopram Hydrobromide Dr. Reddy's Laboratories Limited ANDA Current 55111-344 Citalopram Hydrobromide Citalopram Hydrobromide Dr. Reddy's Laboratories Limited ANDA Current 66116-352 Citalopram Hydrobromide Citalopram Hydrobromide MedVantx, Inc. ANDA Current 66116-353 Citalopram Hydrobromide Citalopram Hydrobromide MedVantx, Inc. ANDA Current 66116-390 Citalopram Hydrobromide Citalopram Hydrobromide MedVantx, Inc. ANDA Current 68645-282 Citalopram hydrobromide Citalopram hydrobromide Legacy Pharmaceutical Packaging ANDA Current 68645-569 Citalopram Hydrobromide Citalopram Hydrobromide Legacy Pharmaceutical Packaging, LLC ANDA Current 68645-569 Citalopram Hydrobromide Citalopram Hydrobromide Legacy Pharmaceutical Packaging, LLC ANDA Current 68645-569 Citalopram Hydrobromide Citalopram Hydrobromide Legacy Pharmaceutical Packaging, LLC ANDA Current 68645-569 Citalopram Hydrobromide Citalopram Hydrobromide Legacy Pharmaceutical Packaging, LLC ANDA Current 68645-570 Citalopram Hydrobromide Citalopram Hydrobromide Legacy Pharmaceutical Packaging, LLC ANDA Current 68645-570 Citalopram Hydrobromide Citalopram Hydrobromide Legacy Pharmaceutical Packaging, LLC ANDA Current 68645-570 Citalopram Hydrobromide Citalopram Hydrobromide Legacy Pharmaceutical Packaging, LLC ANDA Current 68645-570 Citalopram Hydrobromide Citalopram Hydrobromide Legacy Pharmaceutical Packaging, LLC ANDA Current 68645-571 Citalopram Hydrobromide Citalopram Hydrobromide Legacy Pharmaceutical Packaging, LLC ANDA Current 68645-571 Citalopram Hydrobromide Citalopram Hydrobromide Legacy Pharmaceutical Packaging, LLC ANDA Current 68645-571 Citalopram Hydrobromide Citalopram Hydrobromide Legacy Pharmaceutical Packaging, LLC ANDA Current 68645-571 Citalopram Hydrobromide Citalopram Hydrobromide Legacy Pharmaceutical Packaging, LLC ANDA Current 70518-3502 Citalopram Hydrobromide Citalopram Hydrobromide REMEDYREPACK INC. ANDA Current
Documents# Document, Submission type, Date table Document Submission type Date 44332 ORIG 2005-07-29 8997 ORIG 2004-10-29