Home Applications 075616 Application 075616
Type ANDA
Sponsor WATSON LABS 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 A075616-001 NIZATIDINE NIZATIDINE 150MG CAPSULE / ORAL AB 2002-07-09 A075616-002 NIZATIDINE NIZATIDINE 300MG CAPSULE / ORAL AB RS 2002-07-09
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 A075616-001 NIZATIDINE 150MG CAPSULE / ORAL AB 2002-07-09 84e616aacf4f…2026-09-14 22:38:34 2026-08 A075616-002 NIZATIDINE 300MG CAPSULE / ORAL AB RS 2002-07-09 84e616aacf4f…2026-08-18 06:07:40 2026-07 A075616-001 NIZATIDINE 150MG CAPSULE / ORAL AB 2002-07-09 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A075616-002 NIZATIDINE 300MG CAPSULE / ORAL AB RS 2002-07-09 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A075616-001 NIZATIDINE 150MG CAPSULE / ORAL AB 2002-07-09 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A075616-002 NIZATIDINE 300MG CAPSULE / ORAL AB RS 2002-07-09 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075616-001 NIZATIDINE 150MG CAPSULE / ORAL AB 2002-07-09 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075616-002 NIZATIDINE 300MG CAPSULE / ORAL AB RS 2002-07-09 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A075616-001 NIZATIDINE 150MG CAPSULE / ORAL AB 2002-07-09 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A075616-002 NIZATIDINE 300MG CAPSULE / ORAL AB RS 2002-07-09 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075616-001 NIZATIDINE 150MG CAPSULE / ORAL AB 2002-07-09 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075616-002 NIZATIDINE 300MG CAPSULE / ORAL AB RS 2002-07-09 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075616-001 NIZATIDINE 150MG CAPSULE / ORAL AB 2002-07-09 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075616-002 NIZATIDINE 300MG CAPSULE / ORAL AB RS 2002-07-09 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075616-001 NIZATIDINE 150MG CAPSULE / ORAL AB 2002-07-09 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075616-002 NIZATIDINE 300MG CAPSULE / ORAL AB RS 2002-07-09 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075616-001 NIZATIDINE 150MG CAPSULE / ORAL AB 2002-07-09 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075616-002 NIZATIDINE 300MG CAPSULE / ORAL AB RS 2002-07-09 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075616-001 NIZATIDINE 150MG CAPSULE / ORAL AB 2002-07-09 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075616-002 NIZATIDINE 300MG CAPSULE / ORAL AB RS 2002-07-09 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A075616-001 NIZATIDINE 150MG CAPSULE / ORAL AB 2002-07-09 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A075616-002 NIZATIDINE 300MG CAPSULE / ORAL AB RS 2002-07-09 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A075616-001 NIZATIDINE 150MG CAPSULE / ORAL AB 2002-07-09 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A075616-002 NIZATIDINE 300MG CAPSULE / ORAL AB RS 2002-07-09 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A075616-001 NIZATIDINE 150MG CAPSULE / ORAL AB 2002-07-09 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A075616-002 NIZATIDINE 300MG CAPSULE / ORAL AB RS 2002-07-09 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A075616-001 NIZATIDINE 150MG CAPSULE / ORAL AB 2002-07-09 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A075616-002 NIZATIDINE 300MG CAPSULE / ORAL AB RS 2002-07-09 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A075616-001 NIZATIDINE 150MG CAPSULE / ORAL AB 2002-07-09 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A075616-002 NIZATIDINE 300MG CAPSULE / ORAL AB RS 2002-07-09 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A075616-001 NIZATIDINE 150MG CAPSULE / ORAL AB 2002-07-09 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A075616-002 NIZATIDINE 300MG CAPSULE / ORAL AB RS 2002-07-09 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A075616-001 NIZATIDINE 150MG CAPSULE / ORAL AB 2002-07-09 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A075616-002 NIZATIDINE 300MG CAPSULE / ORAL AB RS 2002-07-09 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A075616-001 NIZATIDINE 150MG CAPSULE / ORAL AB 2002-07-09 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A075616-002 NIZATIDINE 300MG CAPSULE / ORAL AB RS 2002-07-09 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A075616-001 NIZATIDINE 150MG CAPSULE / ORAL AB 2002-07-09 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A075616-002 NIZATIDINE 300MG CAPSULE / ORAL AB RS 2002-07-09 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A075616-001 NIZATIDINE 150MG CAPSULE / ORAL AB 2002-07-09 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A075616-002 NIZATIDINE 300MG CAPSULE / ORAL AB 2002-07-09 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 · 9 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0591-3137 Nizatidine Nizatidine Actavis Pharma, Inc. ANDA Current 0591-3138 Nizatidine Nizatidine Actavis Pharma, Inc. ANDA Current 21695-043 Nizatidine Nizatidine Rebel Distributors Corp ANDA Current 42254-093 Nizatidine Nizatidine Rebel Distributors Corp ANDA Current 52959-824 Nizatidine Nizatidine H.J. Harkins Company, Inc. ANDA Current 68071-5043 Nizatidine Nizatidine NuCare Pharmaceuticals,Inc. ANDA Current 68071-5043 Nizatidine Nizatidine NuCare Pharmaceuticals,Inc. ANDA Current 68151-0017 Nizatidine Nizatidine Carilion Materials Management ANDA Current 68258-3006 Nizatidine Nizatidine Dispensing Solutions Inc. ANDA Current
Documents# Document, Submission type, Date table Document Submission type Date 30958 ORIG 2004-06-10