Home Applications 214542 Application 214542
Type ANDA
Sponsor GENUS Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 CHLORPROMAZINE HYDROCHLORIDE CHLORPROMAZINE HYDROCHLORIDE CONCENTRATE;ORAL 30MG/ML No No 002 CHLORPROMAZINE HYDROCHLORIDE CHLORPROMAZINE HYDROCHLORIDE CONCENTRATE;ORAL 100MG/ML No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
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 A214542-001 CHLORPROMAZINE HYDROCHLORIDE CHLORPROMAZINE HYDROCHLORIDE 30MG/ML CONCENTRATE / ORAL AA RS 2021-06-02 A214542-002 CHLORPROMAZINE HYDROCHLORIDE CHLORPROMAZINE HYDROCHLORIDE 100MG/ML CONCENTRATE / ORAL AA RS 2021-06-02
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 2 of 2 · 72 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 2022-03-09 01:35 UTC 2022-03 A214542-001 CHLORPROMAZINE HYDROCHLORIDE 30MG/ML CONCENTRATE / ORAL RS 2021-06-02 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A214542-002 CHLORPROMAZINE HYDROCHLORIDE 100MG/ML CONCENTRATE / ORAL RS 2021-06-02 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A214542-001 CHLORPROMAZINE HYDROCHLORIDE 30MG/ML CONCENTRATE / ORAL RS 2021-06-02 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A214542-002 CHLORPROMAZINE HYDROCHLORIDE 100MG/ML CONCENTRATE / ORAL RS 2021-06-02 782e0a99824c…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A214542-001 CHLORPROMAZINE HYDROCHLORIDE 30MG/ML CONCENTRATE / ORAL RS 2021-06-02 6a51e52b5d6a…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A214542-002 CHLORPROMAZINE HYDROCHLORIDE 100MG/ML CONCENTRATE / ORAL RS 2021-06-02 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A214542-001 CHLORPROMAZINE HYDROCHLORIDE 30MG/ML CONCENTRATE / ORAL RS 2021-06-02 1c564ffb4f44…2024-02-18 07:12 UTC 2024-02 A214542-002 CHLORPROMAZINE HYDROCHLORIDE 100MG/ML CONCENTRATE / ORAL RS 2021-06-02 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A214542-001 CHLORPROMAZINE HYDROCHLORIDE 30MG/ML CONCENTRATE / ORAL RS 2021-06-02 ea1830bbd6c7…2023-12-20 04:57 UTC 2023-12 A214542-002 CHLORPROMAZINE HYDROCHLORIDE 100MG/ML CONCENTRATE / ORAL RS 2021-06-02 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A214542-001 CHLORPROMAZINE HYDROCHLORIDE 30MG/ML CONCENTRATE / ORAL RS 2021-06-02 a72a2bbeb626…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A214542-002 CHLORPROMAZINE HYDROCHLORIDE 100MG/ML CONCENTRATE / ORAL RS 2021-06-02 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A214542-001 CHLORPROMAZINE HYDROCHLORIDE 30MG/ML CONCENTRATE / ORAL RS 2021-06-02 9b2671bbb829…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A214542-002 CHLORPROMAZINE HYDROCHLORIDE 100MG/ML CONCENTRATE / ORAL RS 2021-06-02 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A214542-001 CHLORPROMAZINE HYDROCHLORIDE 30MG/ML CONCENTRATE / ORAL RS 2021-06-02 a67488948f0b…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A214542-002 CHLORPROMAZINE HYDROCHLORIDE 100MG/ML CONCENTRATE / ORAL RS 2021-06-02 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A214542-001 CHLORPROMAZINE HYDROCHLORIDE 30MG/ML CONCENTRATE / ORAL RS 2021-06-02 3f0d92c62455…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A214542-002 CHLORPROMAZINE HYDROCHLORIDE 100MG/ML CONCENTRATE / ORAL RS 2021-06-02 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A214542-001 CHLORPROMAZINE HYDROCHLORIDE 30MG/ML CONCENTRATE / ORAL RS 2021-06-02 053a50430f4f…2023-05-13 08:27 UTC 2023-05 A214542-002 CHLORPROMAZINE HYDROCHLORIDE 100MG/ML CONCENTRATE / ORAL RS 2021-06-02 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A214542-001 CHLORPROMAZINE HYDROCHLORIDE 30MG/ML CONCENTRATE / ORAL RS 2021-06-02 3bdfa0b2c4d7…2023-01-26 05:58 UTC 2023-01 A214542-002 CHLORPROMAZINE HYDROCHLORIDE 100MG/ML CONCENTRATE / ORAL RS 2021-06-02 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A214542-001 CHLORPROMAZINE HYDROCHLORIDE 30MG/ML CONCENTRATE / ORAL RS 2021-06-02 3a93d1ddd44b…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A214542-002 CHLORPROMAZINE HYDROCHLORIDE 100MG/ML CONCENTRATE / ORAL RS 2021-06-02 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A214542-001 CHLORPROMAZINE HYDROCHLORIDE 30MG/ML CONCENTRATE / ORAL RS 2021-06-02 f41ea6bd6efb…2022-10-28 04:53 UTC 2022-10 A214542-002 CHLORPROMAZINE HYDROCHLORIDE 100MG/ML CONCENTRATE / ORAL RS 2021-06-02 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A214542-001 CHLORPROMAZINE HYDROCHLORIDE 30MG/ML CONCENTRATE / ORAL RS 2021-06-02 e64feba35796…2022-09-29 23:25 UTC 2022-09 A214542-002 CHLORPROMAZINE HYDROCHLORIDE 100MG/ML CONCENTRATE / ORAL RS 2021-06-02 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A214542-001 CHLORPROMAZINE HYDROCHLORIDE 30MG/ML CONCENTRATE / ORAL RS 2021-06-02 cb3db0bc1861…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A214542-002 CHLORPROMAZINE HYDROCHLORIDE 100MG/ML CONCENTRATE / ORAL RS 2021-06-02 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A214542-001 CHLORPROMAZINE HYDROCHLORIDE 30MG/ML CONCENTRATE / ORAL AA RS 2021-06-02 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A214542-002 CHLORPROMAZINE HYDROCHLORIDE 100MG/ML CONCENTRATE / ORAL AA RS 2021-06-02 a50c72e98297…
Observed Orange Book normalized TE history# Observed Orange Book exclusivity 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 · 6 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 24338-403 Chlorpromazine Hydrochloride Chlorpromazine Hydrochloride Arbor Pharmaceuticals, LLC ANDA Current 24338-403 Chlorpromazine Hydrochloride Chlorpromazine Hydrochloride Azurity Pharmaceuticals, Inc. ANDA Current 24338-410 Chlorpromazine Hydrochloride Chlorpromazine Hydrochloride Arbor Pharmaceuticals, LLC ANDA Current 24338-410 Chlorpromazine Hydrochloride Chlorpromazine Hydrochloride Azurity Pharmaceuticals, Inc. ANDA Current 64950-240 Chlorpromazine Hydrochloride CHLORPROMAZINE HYDROCHLORIDE Genus Lifesciences Inc. ANDA Current 64950-241 Chlorpromazine Hydrochloride CHLORPROMAZINE HYDROCHLORIDE Genus Lifesciences Inc. ANDA Current
Documents# Document, Submission type, Date table Document Submission type Date 68083 ORIG 2021-07-14