Home Applications 213325 Application 213325
Type ANDA
Sponsor ACME LABS Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 CINACALCET HYDROCHLORIDE CINACALCET HYDROCHLORIDE TABLET;ORAL EQ 30MG BASE No No 002 CINACALCET HYDROCHLORIDE CINACALCET HYDROCHLORIDE TABLET;ORAL EQ 60MG BASE No No 003 CINACALCET HYDROCHLORIDE CINACALCET HYDROCHLORIDE TABLET;ORAL EQ 90MG BASE No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A213325-001 CINACALCET HYDROCHLORIDE CINACALCET HYDROCHLORIDE EQ 30MG BASE TABLET / ORAL AB 2020-05-18 A213325-002 CINACALCET HYDROCHLORIDE CINACALCET HYDROCHLORIDE EQ 60MG BASE TABLET / ORAL AB 2020-05-18 A213325-003 CINACALCET HYDROCHLORIDE CINACALCET HYDROCHLORIDE EQ 90MG BASE TABLET / ORAL AB 2020-05-18
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 3 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 · 111 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 A213325-001 CINACALCET HYDROCHLORIDE EQ 30MG BASE TABLET / ORAL AB 2020-05-18 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A213325-002 CINACALCET HYDROCHLORIDE EQ 60MG BASE TABLET / ORAL AB 2020-05-18 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A213325-003 CINACALCET HYDROCHLORIDE EQ 90MG BASE TABLET / ORAL AB 2020-05-18 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A213325-001 CINACALCET HYDROCHLORIDE EQ 30MG BASE TABLET / ORAL AB 2020-05-18 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A213325-002 CINACALCET HYDROCHLORIDE EQ 60MG BASE TABLET / ORAL AB 2020-05-18 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A213325-003 CINACALCET HYDROCHLORIDE EQ 90MG BASE TABLET / ORAL AB 2020-05-18 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A213325-001 CINACALCET HYDROCHLORIDE EQ 30MG BASE TABLET / ORAL AB 2020-05-18 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A213325-002 CINACALCET HYDROCHLORIDE EQ 60MG BASE TABLET / ORAL AB 2020-05-18 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A213325-003 CINACALCET HYDROCHLORIDE EQ 90MG BASE TABLET / ORAL AB 2020-05-18 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A213325-001 CINACALCET HYDROCHLORIDE EQ 30MG BASE TABLET / ORAL AB 2020-05-18 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A213325-002 CINACALCET HYDROCHLORIDE EQ 60MG BASE TABLET / ORAL AB 2020-05-18 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A213325-003 CINACALCET HYDROCHLORIDE EQ 90MG BASE TABLET / ORAL AB 2020-05-18 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A213325-001 CINACALCET HYDROCHLORIDE EQ 30MG BASE TABLET / ORAL AB 2020-05-18 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A213325-002 CINACALCET HYDROCHLORIDE EQ 60MG BASE TABLET / ORAL AB 2020-05-18 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A213325-003 CINACALCET HYDROCHLORIDE EQ 90MG BASE TABLET / ORAL AB 2020-05-18 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A213325-001 CINACALCET HYDROCHLORIDE EQ 30MG BASE TABLET / ORAL AB 2020-05-18 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A213325-002 CINACALCET HYDROCHLORIDE EQ 60MG BASE TABLET / ORAL AB 2020-05-18 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A213325-003 CINACALCET HYDROCHLORIDE EQ 90MG BASE TABLET / ORAL AB 2020-05-18 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A213325-001 CINACALCET HYDROCHLORIDE EQ 30MG BASE TABLET / ORAL AB 2020-05-18 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A213325-002 CINACALCET HYDROCHLORIDE EQ 60MG BASE TABLET / ORAL AB 2020-05-18 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A213325-003 CINACALCET HYDROCHLORIDE EQ 90MG BASE TABLET / ORAL AB 2020-05-18 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A213325-001 CINACALCET HYDROCHLORIDE EQ 30MG BASE TABLET / ORAL AB 2020-05-18 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A213325-002 CINACALCET HYDROCHLORIDE EQ 60MG BASE TABLET / ORAL AB 2020-05-18 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A213325-003 CINACALCET HYDROCHLORIDE EQ 90MG BASE TABLET / ORAL AB 2020-05-18 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A213325-001 CINACALCET HYDROCHLORIDE EQ 30MG BASE TABLET / ORAL AB 2020-05-18 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A213325-002 CINACALCET HYDROCHLORIDE EQ 60MG BASE TABLET / ORAL AB 2020-05-18 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A213325-003 CINACALCET HYDROCHLORIDE EQ 90MG BASE TABLET / ORAL AB 2020-05-18 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A213325-001 CINACALCET HYDROCHLORIDE EQ 30MG BASE TABLET / ORAL AB 2020-05-18 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A213325-002 CINACALCET HYDROCHLORIDE EQ 60MG BASE TABLET / ORAL AB 2020-05-18 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A213325-003 CINACALCET HYDROCHLORIDE EQ 90MG BASE TABLET / ORAL AB 2020-05-18 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A213325-001 CINACALCET HYDROCHLORIDE EQ 30MG BASE TABLET / ORAL AB 2020-05-18 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A213325-002 CINACALCET HYDROCHLORIDE EQ 60MG BASE TABLET / ORAL AB 2020-05-18 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A213325-003 CINACALCET HYDROCHLORIDE EQ 90MG BASE TABLET / ORAL AB 2020-05-18 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A213325-001 CINACALCET HYDROCHLORIDE EQ 30MG BASE TABLET / ORAL AB 2020-05-18 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A213325-002 CINACALCET HYDROCHLORIDE EQ 60MG BASE TABLET / ORAL AB 2020-05-18 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A213325-003 CINACALCET HYDROCHLORIDE EQ 90MG BASE TABLET / ORAL AB 2020-05-18 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A213325-001 CINACALCET HYDROCHLORIDE EQ 30MG BASE TABLET / ORAL AB 2020-05-18 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A213325-002 CINACALCET HYDROCHLORIDE EQ 60MG BASE TABLET / ORAL AB 2020-05-18 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A213325-003 CINACALCET HYDROCHLORIDE EQ 90MG BASE TABLET / ORAL AB 2020-05-18 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A213325-001 CINACALCET HYDROCHLORIDE EQ 30MG BASE TABLET / ORAL AB 2020-05-18 8072bd15b7f6…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 111 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 · 2 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 71093-152 Cinacalcet Cinacalcet Hydrochloride ACI Healthcare USA, Inc ANDA Current 71093-152 Cinacalcet Cinacalcet Hydrochloride ACI Healthcare USA, Inc ANDA Current 71093-152 Cinacalcet Cinacalcet Hydrochloride ACI Healthcare USA, Inc ANDA Current 71093-153 Cinacalcet Cinacalcet Hydrochloride ACI Healthcare USA, Inc ANDA Current 71093-153 Cinacalcet Cinacalcet Hydrochloride ACI Healthcare USA, Inc ANDA Current 71093-153 Cinacalcet Cinacalcet Hydrochloride ACI Healthcare USA, Inc ANDA Current 71093-154 Cinacalcet Cinacalcet Hydrochloride ACI Healthcare USA, Inc ANDA Current 71093-154 Cinacalcet Cinacalcet Hydrochloride ACI Healthcare USA, Inc ANDA Current 71093-154 Cinacalcet Cinacalcet Hydrochloride ACI Healthcare USA, Inc ANDA Current