Home Applications 020458 Application 020458
Type NDA
Sponsor TEVA Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 GALZIN ZINC ACETATE CAPSULE;ORAL EQ 25MG ZINC Yes No 002 GALZIN ZINC ACETATE CAPSULE;ORAL EQ 50MG ZINC Yes Yes
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
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 N020458-001 GALZIN ZINC ACETATE EQ 25MG ZINC CAPSULE / ORAL RLD 1997-01-28 N020458-002 GALZIN ZINC ACETATE EQ 50MG ZINC CAPSULE / ORAL RLD, RS 1997-01-28
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 · 82 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 N020458-001 GALZIN EQ 25MG ZINC CAPSULE / ORAL RLD 1997-01-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N020458-002 GALZIN EQ 50MG ZINC CAPSULE / ORAL RLD, RS 1997-01-28 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020458-001 GALZIN EQ 25MG ZINC CAPSULE / ORAL RLD 1997-01-28 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020458-002 GALZIN EQ 50MG ZINC CAPSULE / ORAL RLD, RS 1997-01-28 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N020458-001 GALZIN EQ 25MG ZINC CAPSULE / ORAL RLD 1997-01-28 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N020458-002 GALZIN EQ 50MG ZINC CAPSULE / ORAL RLD, RS 1997-01-28 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020458-001 GALZIN EQ 25MG ZINC CAPSULE / ORAL RLD 1997-01-28 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020458-002 GALZIN EQ 50MG ZINC CAPSULE / ORAL RLD, RS 1997-01-28 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020458-001 GALZIN EQ 25MG ZINC CAPSULE / ORAL RLD 1997-01-28 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020458-002 GALZIN EQ 50MG ZINC CAPSULE / ORAL RLD, RS 1997-01-28 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020458-001 GALZIN EQ 25MG ZINC CAPSULE / ORAL RLD 1997-01-28 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020458-002 GALZIN EQ 50MG ZINC CAPSULE / ORAL RLD, RS 1997-01-28 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020458-001 GALZIN EQ 25MG ZINC CAPSULE / ORAL RLD 1997-01-28 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020458-002 GALZIN EQ 50MG ZINC CAPSULE / ORAL RLD, RS 1997-01-28 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020458-001 GALZIN EQ 25MG ZINC CAPSULE / ORAL RLD 1997-01-28 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020458-002 GALZIN EQ 50MG ZINC CAPSULE / ORAL RLD, RS 1997-01-28 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020458-001 GALZIN EQ 25MG ZINC CAPSULE / ORAL RLD 1997-01-28 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020458-002 GALZIN EQ 50MG ZINC CAPSULE / ORAL RLD, RS 1997-01-28 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N020458-001 GALZIN EQ 25MG ZINC CAPSULE / ORAL RLD 1997-01-28 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N020458-002 GALZIN EQ 50MG ZINC CAPSULE / ORAL RLD, RS 1997-01-28 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N020458-001 GALZIN EQ 25MG ZINC CAPSULE / ORAL RLD 1997-01-28 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N020458-002 GALZIN EQ 50MG ZINC CAPSULE / ORAL RLD, RS 1997-01-28 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N020458-001 GALZIN EQ 25MG ZINC CAPSULE / ORAL RLD 1997-01-28 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N020458-002 GALZIN EQ 50MG ZINC CAPSULE / ORAL RLD, RS 1997-01-28 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N020458-001 GALZIN EQ 25MG ZINC CAPSULE / ORAL RLD 1997-01-28 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N020458-002 GALZIN EQ 50MG ZINC CAPSULE / ORAL RLD, RS 1997-01-28 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N020458-001 GALZIN EQ 25MG ZINC CAPSULE / ORAL RLD 1997-01-28 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N020458-002 GALZIN EQ 50MG ZINC CAPSULE / ORAL RLD, RS 1997-01-28 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N020458-001 GALZIN EQ 25MG ZINC CAPSULE / ORAL RLD 1997-01-28 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N020458-002 GALZIN EQ 50MG ZINC CAPSULE / ORAL RLD, RS 1997-01-28 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N020458-001 GALZIN EQ 25MG ZINC CAPSULE / ORAL RLD 1997-01-28 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N020458-002 GALZIN EQ 50MG ZINC CAPSULE / ORAL RLD, RS 1997-01-28 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N020458-001 GALZIN EQ 25MG ZINC CAPSULE / ORAL RLD 1997-01-28 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N020458-002 GALZIN EQ 50MG ZINC CAPSULE / ORAL RLD, RS 1997-01-28 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N020458-001 GALZIN EQ 25MG ZINC CAPSULE / ORAL RLD 1997-01-28 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N020458-002 GALZIN EQ 50MG ZINC CAPSULE / ORAL RLD, RS 1997-01-28 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N020458-001 GALZIN EQ 25MG ZINC CAPSULE / ORAL RLD 1997-01-28 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N020458-002 GALZIN EQ 50MG ZINC CAPSULE / ORAL RLD, RS 1997-01-28 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N020458-001 GALZIN EQ 25MG ZINC CAPSULE / ORAL RLD 1997-01-28 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N020458-002 GALZIN EQ 50MG ZINC CAPSULE / ORAL RLD, RS 1997-01-28 782e0a99824c…
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 · 16 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 57844-208 GALZIN Zinc Acetate Teva Select Brands NDA Current 57844-208 GALZIN Zinc Acetate Teva Pharmaceuticals USA, Inc. NDA Current 57844-208 GALZIN Zinc Acetate Teva Pharmaceuticals USA, Inc. NDA Current 57844-208 GALZIN Zinc Acetate Teva Pharmaceuticals USA, Inc. NDA Current 57844-208 GALZIN Zinc Acetate Teva Select Brands NDA Current 57844-208 GALZIN Zinc Acetate Teva Pharmaceuticals USA, Inc. NDA Current 57844-208 GALZIN Zinc Acetate Teva Pharmaceuticals USA, Inc. NDA Current 57844-208 GALZIN Zinc Acetate Teva Pharmaceuticals USA, Inc. NDA Current 57844-215 GALZIN Zinc Acetate Teva Select Brands NDA Current 57844-215 GALZIN Zinc Acetate Teva Pharmaceuticals USA, Inc. NDA Current 57844-215 GALZIN Zinc Acetate Teva Pharmaceuticals USA, Inc. NDA Current 57844-215 GALZIN Zinc Acetate Teva Pharmaceuticals USA, Inc. NDA Current 57844-215 GALZIN Zinc Acetate Teva Select Brands NDA Current 57844-215 GALZIN Zinc Acetate Teva Pharmaceuticals USA, Inc. NDA Current 57844-215 GALZIN Zinc Acetate Teva Pharmaceuticals USA, Inc. NDA Current 57844-215 GALZIN Zinc Acetate Teva Pharmaceuticals USA, Inc. NDA Current
Documents# Document, Submission type, Date table Document Submission type Date 78293 SUPPL 2024-04-29 78271 SUPPL 2024-04-26 24998 SUPPL 2002-03-14 20667 ORIG 1997-01-28