Home Applications 074664 Application 074664
Type ANDA
Sponsor HI TECH PHARMA Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 CIMETIDINE HYDROCHLORIDE CIMETIDINE HYDROCHLORIDE SOLUTION;ORAL EQ 300MG BASE/5ML No 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 A074664-001 CIMETIDINE HYDROCHLORIDE CIMETIDINE HYDROCHLORIDE EQ 300MG BASE/5ML SOLUTION / ORAL AA RS 1997-10-28
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A074664-001 AA
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 A074664-001 CIMETIDINE HYDROCHLORIDE EQ 300MG BASE/5ML SOLUTION / ORAL AA RS 1997-10-28 84e616aacf4f…2026-08-18 06:07:40 2026-07 A074664-001 CIMETIDINE HYDROCHLORIDE EQ 300MG BASE/5ML SOLUTION / ORAL AA RS 1997-10-28 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A074664-001 CIMETIDINE HYDROCHLORIDE EQ 300MG BASE/5ML SOLUTION / ORAL AA RS 1997-10-28 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A074664-001 CIMETIDINE HYDROCHLORIDE EQ 300MG BASE/5ML SOLUTION / ORAL AA RS 1997-10-28 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A074664-001 CIMETIDINE HYDROCHLORIDE EQ 300MG BASE/5ML SOLUTION / ORAL AA RS 1997-10-28 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A074664-001 CIMETIDINE HYDROCHLORIDE EQ 300MG BASE/5ML SOLUTION / ORAL AA RS 1997-10-28 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A074664-001 CIMETIDINE HYDROCHLORIDE EQ 300MG BASE/5ML SOLUTION / ORAL AA RS 1997-10-28 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A074664-001 CIMETIDINE HYDROCHLORIDE EQ 300MG BASE/5ML SOLUTION / ORAL AA RS 1997-10-28 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A074664-001 CIMETIDINE HYDROCHLORIDE EQ 300MG BASE/5ML SOLUTION / ORAL AA RS 1997-10-28 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A074664-001 CIMETIDINE HYDROCHLORIDE EQ 300MG BASE/5ML SOLUTION / ORAL 1997-10-28 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A074664-001 CIMETIDINE HYDROCHLORIDE EQ 300MG BASE/5ML SOLUTION / ORAL RS 1997-10-28 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A074664-001 CIMETIDINE HYDROCHLORIDE EQ 300MG BASE/5ML SOLUTION / ORAL RS 1997-10-28 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A074664-001 CIMETIDINE HYDROCHLORIDE EQ 300MG BASE/5ML SOLUTION / ORAL 1997-10-28 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A074664-001 CIMETIDINE HYDROCHLORIDE EQ 300MG BASE/5ML SOLUTION / ORAL 1997-10-28 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A074664-001 CIMETIDINE HYDROCHLORIDE EQ 300MG BASE/5ML SOLUTION / ORAL 1997-10-28 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A074664-001 CIMETIDINE HYDROCHLORIDE EQ 300MG BASE/5ML SOLUTION / ORAL 1997-10-28 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A074664-001 CIMETIDINE HYDROCHLORIDE EQ 300MG BASE/5ML SOLUTION / ORAL AA RS 1997-10-28 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A074664-001 CIMETIDINE HYDROCHLORIDE EQ 300MG BASE/5ML SOLUTION / ORAL AA RS 1997-10-28 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A074664-001 CIMETIDINE HYDROCHLORIDE EQ 300MG BASE/5ML SOLUTION / ORAL AA RS 1997-10-28 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A074664-001 CIMETIDINE HYDROCHLORIDE EQ 300MG BASE/5ML SOLUTION / ORAL AA RS 1997-10-28 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A074664-001 CIMETIDINE HYDROCHLORIDE EQ 300MG BASE/5ML SOLUTION / ORAL AA RS 1997-10-28 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A074664-001 CIMETIDINE HYDROCHLORIDE EQ 300MG BASE/5ML SOLUTION / ORAL AA RS 1997-10-28 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A074664-001 CIMETIDINE HYDROCHLORIDE EQ 300MG BASE/5ML SOLUTION / ORAL AA RS 1997-10-28 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A074664-001 CIMETIDINE HYDROCHLORIDE EQ 300MG BASE/5ML SOLUTION / ORAL AA RS 1997-10-28 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A074664-001 CIMETIDINE HYDROCHLORIDE EQ 300MG BASE/5ML SOLUTION / ORAL AA RS 1997-10-28 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A074664-001 CIMETIDINE HYDROCHLORIDE EQ 300MG BASE/5ML SOLUTION / ORAL AA RS 1997-10-28 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A074664-001 CIMETIDINE HYDROCHLORIDE EQ 300MG BASE/5ML SOLUTION / ORAL AA RS 1997-10-28 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A074664-001 CIMETIDINE HYDROCHLORIDE EQ 300MG BASE/5ML SOLUTION / ORAL AA RS 1997-10-28 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A074664-001 CIMETIDINE HYDROCHLORIDE EQ 300MG BASE/5ML SOLUTION / ORAL AA RS 1997-10-28 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A074664-001 CIMETIDINE HYDROCHLORIDE EQ 300MG BASE/5ML SOLUTION / ORAL 1997-10-28 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A074664-001 CIMETIDINE HYDROCHLORIDE EQ 300MG BASE/5ML SOLUTION / ORAL AA RS 1997-10-28 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A074664-001 CIMETIDINE HYDROCHLORIDE EQ 300MG BASE/5ML SOLUTION / ORAL AA RS 1997-10-28 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A074664-001 CIMETIDINE HYDROCHLORIDE EQ 300MG BASE/5ML SOLUTION / ORAL AA RS 1997-10-28 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A074664-001 CIMETIDINE HYDROCHLORIDE EQ 300MG BASE/5ML SOLUTION / ORAL AA RS 1997-10-28 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A074664-001 CIMETIDINE HYDROCHLORIDE EQ 300MG BASE/5ML SOLUTION / ORAL AA RS 1997-10-28 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A074664-001 CIMETIDINE HYDROCHLORIDE EQ 300MG BASE/5ML SOLUTION / ORAL AA RS 1997-10-28 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A074664-001 CIMETIDINE HYDROCHLORIDE EQ 300MG BASE/5ML SOLUTION / ORAL AA RS 1997-10-28 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A074664-001 CIMETIDINE HYDROCHLORIDE EQ 300MG BASE/5ML SOLUTION / ORAL AA RS 1997-10-28 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A074664-001 CIMETIDINE HYDROCHLORIDE EQ 300MG BASE/5ML SOLUTION / ORAL AA RS 1997-10-28 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A074664-001 CIMETIDINE HYDROCHLORIDE EQ 300MG BASE/5ML SOLUTION / ORAL AA RS 1997-10-28 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 · 1 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 · 5 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 50383-050 Cimetidine Hydrochloride Oral Solution Cimetidine Hydrochloride Oral Solution Akorn Operating Company LLC ANDA Current 50383-050 Cimetidine Hydrochloride Oral Solution Cimetidine Hydrochloride Oral Solution Hi-Tech Pharmacal Co., Inc. ANDA Current 50383-050 Cimetidine Hydrochloride Oral Solution Cimetidine Hydrochloride Oral Solution Hi-Tech Pharmacal Co., Inc. ANDA Current 50383-966 CIMETIDINE HYDROCHLORIDE CIMETIDINE HYDROCHLORIDE Akorn ANDA Current 50383-966 CIMETIDINE HYDROCHLORIDE CIMETIDINE HYDROCHLORIDE Hi-Tech Pharmacal Co., Inc. ANDA Current
Documents# Document, Submission type, Date table Document Submission type Date 42859 ORIG 2005-07-22 76423 ORIG 2004-05-26 8429 ORIG 2004-05-26