Home Applications 077314 Application 077314
Type ANDA
Sponsor DR REDDYS LABS LTD Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 NIZATIDINE NIZATIDINE CAPSULE;ORAL 150MG No No 002 NIZATIDINE NIZATIDINE CAPSULE;ORAL 300MG No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A077314-001 NIZATIDINE NIZATIDINE 150MG CAPSULE / ORAL AB 2005-09-15 A077314-002 NIZATIDINE NIZATIDINE 300MG CAPSULE / ORAL AB 2005-09-15
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 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 3 · 86 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 A077314-001 NIZATIDINE 150MG CAPSULE / ORAL AB 2005-09-15 84e616aacf4f…2026-09-14 22:38:34 2026-08 A077314-002 NIZATIDINE 300MG CAPSULE / ORAL AB 2005-09-15 84e616aacf4f…2026-08-18 06:07:40 2026-07 A077314-001 NIZATIDINE 150MG CAPSULE / ORAL AB 2005-09-15 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A077314-002 NIZATIDINE 300MG CAPSULE / ORAL AB 2005-09-15 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A077314-001 NIZATIDINE 150MG CAPSULE / ORAL AB 2005-09-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A077314-002 NIZATIDINE 300MG CAPSULE / ORAL AB 2005-09-15 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077314-001 NIZATIDINE 150MG CAPSULE / ORAL AB 2005-09-15 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077314-002 NIZATIDINE 300MG CAPSULE / ORAL AB 2005-09-15 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A077314-001 NIZATIDINE 150MG CAPSULE / ORAL AB 2005-09-15 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A077314-002 NIZATIDINE 300MG CAPSULE / ORAL AB 2005-09-15 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077314-001 NIZATIDINE 150MG CAPSULE / ORAL AB 2005-09-15 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077314-002 NIZATIDINE 300MG CAPSULE / ORAL AB 2005-09-15 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077314-001 NIZATIDINE 150MG CAPSULE / ORAL AB 2005-09-15 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077314-002 NIZATIDINE 300MG CAPSULE / ORAL AB 2005-09-15 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077314-001 NIZATIDINE 150MG CAPSULE / ORAL AB 2005-09-15 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077314-002 NIZATIDINE 300MG CAPSULE / ORAL AB 2005-09-15 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077314-001 NIZATIDINE 150MG CAPSULE / ORAL AB 2005-09-15 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077314-002 NIZATIDINE 300MG CAPSULE / ORAL AB 2005-09-15 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077314-001 NIZATIDINE 150MG CAPSULE / ORAL AB 2005-09-15 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077314-002 NIZATIDINE 300MG CAPSULE / ORAL AB 2005-09-15 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077314-001 NIZATIDINE 150MG CAPSULE / ORAL AB 2005-09-15 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077314-002 NIZATIDINE 300MG CAPSULE / ORAL AB 2005-09-15 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A077314-001 NIZATIDINE 150MG CAPSULE / ORAL AB 2005-09-15 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A077314-002 NIZATIDINE 300MG CAPSULE / ORAL AB 2005-09-15 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A077314-001 NIZATIDINE 150MG CAPSULE / ORAL AB 2005-09-15 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A077314-002 NIZATIDINE 300MG CAPSULE / ORAL AB 2005-09-15 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A077314-001 NIZATIDINE 150MG CAPSULE / ORAL AB 2005-09-15 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A077314-002 NIZATIDINE 300MG CAPSULE / ORAL AB 2005-09-15 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A077314-001 NIZATIDINE 150MG CAPSULE / ORAL AB 2005-09-15 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A077314-002 NIZATIDINE 300MG CAPSULE / ORAL AB 2005-09-15 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A077314-001 NIZATIDINE 150MG CAPSULE / ORAL AB 2005-09-15 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A077314-002 NIZATIDINE 300MG CAPSULE / ORAL AB 2005-09-15 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A077314-001 NIZATIDINE 150MG CAPSULE / ORAL AB 2005-09-15 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A077314-002 NIZATIDINE 300MG CAPSULE / ORAL AB 2005-09-15 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A077314-001 NIZATIDINE 150MG CAPSULE / ORAL AB 2005-09-15 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A077314-002 NIZATIDINE 300MG CAPSULE / ORAL AB 2005-09-15 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A077314-001 NIZATIDINE 150MG CAPSULE / ORAL AB 2005-09-15 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A077314-002 NIZATIDINE 300MG CAPSULE / ORAL AB 2005-09-15 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A077314-001 NIZATIDINE 150MG CAPSULE / ORAL AB 2005-09-15 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A077314-002 NIZATIDINE 300MG CAPSULE / ORAL AB 2005-09-15 74a2ff9319b5…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 86 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.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 4 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 55111-310 Nizatidine Nizatidine Dr Reddy's Laboratories Limited ANDA Current 55111-311 Nizatidine Nizatidine Dr Reddy's Laboratories Limited ANDA Current 63629-2769 Nizatidine Nizatidine Bryant Ranch Prepack ANDA Current 63629-2769 Nizatidine Nizatidine Bryant Ranch Prepack ANDA Current