Home Applications 019090 Application 019090
Type NDA
Sponsor TELIGENT Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 ZANTAC RANITIDINE HYDROCHLORIDE INJECTABLE;INJECTION EQ 25MG BASE/ML Yes Yes
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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 N019090-001 ZANTAC RANITIDINE HYDROCHLORIDE EQ 25MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION RLD 1984-10-19
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 · 43 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 N019090-001 ZANTAC EQ 25MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION RLD 1984-10-19 84e616aacf4f…2026-08-18 06:07:40 2026-07 N019090-001 ZANTAC EQ 25MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION RLD 1984-10-19 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N019090-001 ZANTAC EQ 25MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION RLD 1984-10-19 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N019090-001 ZANTAC EQ 25MG BASE/ML INJECTABLE / INJECTION RLD 1984-10-19 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N019090-001 ZANTAC EQ 25MG BASE/ML INJECTABLE / INJECTION RLD 1984-10-19 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N019090-001 ZANTAC EQ 25MG BASE/ML INJECTABLE / INJECTION RLD 1984-10-19 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N019090-001 ZANTAC EQ 25MG BASE/ML INJECTABLE / INJECTION RLD 1984-10-19 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N019090-001 ZANTAC EQ 25MG BASE/ML INJECTABLE / INJECTION RLD 1984-10-19 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N019090-001 ZANTAC EQ 25MG BASE/ML INJECTABLE / INJECTION RLD 1984-10-19 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N019090-001 ZANTAC EQ 25MG BASE/ML INJECTABLE / INJECTION RLD 1984-10-19 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N019090-001 ZANTAC EQ 25MG BASE/ML INJECTABLE / INJECTION RLD 1984-10-19 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N019090-001 ZANTAC EQ 25MG BASE/ML INJECTABLE / INJECTION RLD 1984-10-19 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N019090-001 ZANTAC EQ 25MG BASE/ML INJECTABLE / INJECTION RLD 1984-10-19 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N019090-001 ZANTAC EQ 25MG BASE/ML INJECTABLE / INJECTION RLD 1984-10-19 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N019090-001 ZANTAC EQ 25MG BASE/ML INJECTABLE / INJECTION RLD 1984-10-19 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N019090-001 ZANTAC EQ 25MG BASE/ML INJECTABLE / INJECTION RLD 1984-10-19 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N019090-001 ZANTAC EQ 25MG BASE/ML INJECTABLE / INJECTION AP RLD, RS 1984-10-19 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N019090-001 ZANTAC EQ 25MG BASE/ML INJECTABLE / INJECTION AP RLD, RS 1984-10-19 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N019090-001 ZANTAC EQ 25MG BASE/ML INJECTABLE / INJECTION AP RLD, RS 1984-10-19 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N019090-001 ZANTAC EQ 25MG BASE/ML INJECTABLE / INJECTION AP RLD, RS 1984-10-19 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N019090-001 ZANTAC EQ 25MG BASE/ML INJECTABLE / INJECTION AP RLD, RS 1984-10-19 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N019090-001 ZANTAC EQ 25MG BASE/ML INJECTABLE / INJECTION AP RLD, RS 1984-10-19 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N019090-001 ZANTAC EQ 25MG BASE/ML INJECTABLE / INJECTION AP RLD, RS 1984-10-19 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N019090-001 ZANTAC EQ 25MG BASE/ML INJECTABLE / INJECTION AP RLD, RS 1984-10-19 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N019090-001 ZANTAC EQ 25MG BASE/ML INJECTABLE / INJECTION AP RLD, RS 1984-10-19 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N019090-001 ZANTAC EQ 25MG BASE/ML INJECTABLE / INJECTION AP RLD, RS 1984-10-19 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N019090-001 ZANTAC EQ 25MG BASE/ML INJECTABLE / INJECTION AP RLD, RS 1984-10-19 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N019090-001 ZANTAC EQ 25MG BASE/ML INJECTABLE / INJECTION AP RLD, RS 1984-10-19 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N019090-001 ZANTAC EQ 25MG BASE/ML INJECTABLE / INJECTION AP RLD, RS 1984-10-19 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N019090-001 ZANTAC EQ 25MG BASE/ML INJECTABLE / INJECTION RLD 1984-10-19 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N019090-001 ZANTAC EQ 25MG BASE/ML INJECTABLE / INJECTION RLD 1984-10-19 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N019090-001 ZANTAC EQ 25MG BASE/ML INJECTABLE / INJECTION RLD 1984-10-19 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N019090-001 ZANTAC EQ 25MG BASE/ML INJECTABLE / INJECTION RLD 1984-10-19 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N019090-001 ZANTAC EQ 25MG BASE/ML INJECTABLE / INJECTION RLD 1984-10-19 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N019090-001 ZANTAC EQ 25MG BASE/ML INJECTABLE / INJECTION RLD 1984-10-19 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N019090-001 ZANTAC EQ 25MG BASE/ML INJECTABLE / INJECTION RLD 1984-10-19 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N019090-001 ZANTAC EQ 25MG BASE/ML INJECTABLE / INJECTION AP RLD, RS 1984-10-19 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N019090-001 ZANTAC EQ 25MG BASE/ML INJECTABLE / INJECTION AP RLD, RS 1984-10-19 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N019090-001 ZANTAC EQ 25MG BASE/ML INJECTABLE / INJECTION AP RLD, RS 1984-10-19 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N019090-001 ZANTAC EQ 25MG BASE/ML INJECTABLE / INJECTION AP RLD, RS 1984-10-19 f41ea6bd6efb…
Observed Orange Book normalized TE history# 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.
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 · 9 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 52565-096 ZANTAC ranitidine hydrochloride Teligent Pharma, Inc. NDA Current 52565-096 ZANTAC ranitidine hydrochloride Teligent, Inc. NDA Current 52565-096 ZANTAC ranitidine hydrochloride Teligent Pharma, Inc. NDA Current 52565-101 ZANTAC ranitidine hydrochloride Teligent Pharma, Inc. NDA Current 52565-101 ZANTAC ranitidine hydrochloride Teligent Pharma, Inc. NDA Current 52565-101 ZANTAC ranitidine hydrochloride Teligent Pharma, Inc. NDA Current 52565-102 ZANTAC ranitidine hydrochloride Teligent Pharma, Inc. NDA Current 52565-102 ZANTAC ranitidine hydrochloride Teligent Pharma, Inc. NDA Current 52565-102 ZANTAC ranitidine hydrochloride Teligent Pharma, Inc. NDA Current
Documents# Document, Submission type, Date table Document Submission type Date 16194 SUPPL 2009-11-12 33697 SUPPL 2009-10-06 33696 SUPPL 2009-03-27 1226 SUPPL 2009-02-19 16193 SUPPL 2006-07-21 16191 SUPPL 2004-07-01 20205 SUPPL 2003-04-29 16192 SUPPL 2002-01-07