Home Applications 021278 Application 021278
Type NDA
Sponsor NOVARTIS Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 FOCALIN DEXMETHYLPHENIDATE HYDROCHLORIDE TABLET;ORAL 2.5MG Yes No 002 FOCALIN DEXMETHYLPHENIDATE HYDROCHLORIDE TABLET;ORAL 5MG Yes No 003 FOCALIN DEXMETHYLPHENIDATE HYDROCHLORIDE TABLET;ORAL 10MG Yes Yes
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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 N021278-001 FOCALIN DEXMETHYLPHENIDATE HYDROCHLORIDE 2.5MG TABLET / ORAL AB RLD 2001-11-13 N021278-002 FOCALIN DEXMETHYLPHENIDATE HYDROCHLORIDE 5MG TABLET / ORAL AB RLD 2001-11-13 N021278-003 FOCALIN DEXMETHYLPHENIDATE HYDROCHLORIDE 10MG TABLET / ORAL AB RLD, RS 2001-11-13
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 4 · 129 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 N021278-001 FOCALIN 2.5MG TABLET / ORAL AB RLD 2001-11-13 84e616aacf4f…2026-09-14 22:38:34 2026-08 N021278-002 FOCALIN 5MG TABLET / ORAL AB RLD 2001-11-13 84e616aacf4f…2026-09-14 22:38:34 2026-08 N021278-003 FOCALIN 10MG TABLET / ORAL AB RLD, RS 2001-11-13 84e616aacf4f…2026-08-18 06:07:40 2026-07 N021278-001 FOCALIN 2.5MG TABLET / ORAL AB RLD 2001-11-13 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N021278-002 FOCALIN 5MG TABLET / ORAL AB RLD 2001-11-13 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N021278-003 FOCALIN 10MG TABLET / ORAL AB RLD, RS 2001-11-13 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N021278-001 FOCALIN 2.5MG TABLET / ORAL AB RLD 2001-11-13 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021278-002 FOCALIN 5MG TABLET / ORAL AB RLD 2001-11-13 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021278-003 FOCALIN 10MG TABLET / ORAL AB RLD, RS 2001-11-13 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021278-001 FOCALIN 2.5MG TABLET / ORAL AB RLD 2001-11-13 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021278-002 FOCALIN 5MG TABLET / ORAL AB RLD 2001-11-13 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021278-003 FOCALIN 10MG TABLET / ORAL AB RLD, RS 2001-11-13 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N021278-001 FOCALIN 2.5MG TABLET / ORAL AB RLD 2001-11-13 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021278-002 FOCALIN 5MG TABLET / ORAL AB RLD 2001-11-13 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021278-003 FOCALIN 10MG TABLET / ORAL AB RLD, RS 2001-11-13 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021278-001 FOCALIN 2.5MG TABLET / ORAL AB RLD 2001-11-13 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021278-002 FOCALIN 5MG TABLET / ORAL AB RLD 2001-11-13 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021278-003 FOCALIN 10MG TABLET / ORAL AB RLD, RS 2001-11-13 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021278-001 FOCALIN 2.5MG TABLET / ORAL AB RLD 2001-11-13 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021278-002 FOCALIN 5MG TABLET / ORAL AB RLD 2001-11-13 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021278-003 FOCALIN 10MG TABLET / ORAL AB RLD, RS 2001-11-13 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021278-001 FOCALIN 2.5MG TABLET / ORAL AB RLD 2001-11-13 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021278-002 FOCALIN 5MG TABLET / ORAL AB RLD 2001-11-13 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021278-003 FOCALIN 10MG TABLET / ORAL AB RLD, RS 2001-11-13 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021278-001 FOCALIN 2.5MG TABLET / ORAL AB RLD 2001-11-13 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021278-002 FOCALIN 5MG TABLET / ORAL AB RLD 2001-11-13 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021278-003 FOCALIN 10MG TABLET / ORAL AB RLD, RS 2001-11-13 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021278-001 FOCALIN 2.5MG TABLET / ORAL AB RLD 2001-11-13 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021278-002 FOCALIN 5MG TABLET / ORAL AB RLD 2001-11-13 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021278-003 FOCALIN 10MG TABLET / ORAL AB RLD, RS 2001-11-13 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021278-001 FOCALIN 2.5MG TABLET / ORAL AB RLD 2001-11-13 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021278-002 FOCALIN 5MG TABLET / ORAL AB RLD 2001-11-13 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021278-003 FOCALIN 10MG TABLET / ORAL AB RLD, RS 2001-11-13 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N021278-001 FOCALIN 2.5MG TABLET / ORAL AB RLD 2001-11-13 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N021278-002 FOCALIN 5MG TABLET / ORAL AB RLD 2001-11-13 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N021278-003 FOCALIN 10MG TABLET / ORAL AB RLD, RS 2001-11-13 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021278-001 FOCALIN 2.5MG TABLET / ORAL AB RLD 2001-11-13 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021278-002 FOCALIN 5MG TABLET / ORAL AB RLD 2001-11-13 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021278-003 FOCALIN 10MG TABLET / ORAL AB RLD, RS 2001-11-13 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021278-001 FOCALIN 2.5MG TABLET / ORAL AB RLD 2001-11-13 301d65b070ca…
Observed Orange Book normalized TE history# Normalized TE history page 4 of 4 · 129 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 · 1 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Focalin DEXMETHYLPHENIDATE HYDROCHLORIDE Sandoz Inc 2016f5c2-95d2-4655-af65-c588c2bf5e6d 2024-05-30 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 021278 application number: NDA021278
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 · 27 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0078-0380 Focalin dexmethylphenidate hydrochloride Novartis Pharmaceuticals Corporation NDA Current 0078-0380 Focalin dexmethylphenidate hydrochloride Novartis Pharmaceuticals Corporation NDA Current 0078-0380 Focalin dexmethylphenidate hydrochloride Novartis Pharmaceuticals Corporation NDA Current 0078-0380 Focalin dexmethylphenidate hydrochloride Novartis Pharmaceuticals Corporation NDA Current 0078-0380 Focalin dexmethylphenidate hydrochloride Novartis Pharmaceuticals Corporation NDA Current 0078-0380 Focalin dexmethylphenidate hydrochloride Novartis Pharmaceuticals Corporation NDA Current 0078-0380 Focalin dexmethylphenidate hydrochloride Novartis Pharmaceuticals Corporation NDA Current 0078-0381 Focalin dexmethylphenidate hydrochloride Novartis Pharmaceuticals Corporation NDA Current 0078-0381 Focalin dexmethylphenidate hydrochloride Novartis Pharmaceuticals Corporation NDA Current 0078-0381 Focalin dexmethylphenidate hydrochloride Novartis Pharmaceuticals Corporation NDA Current 0078-0381 Focalin dexmethylphenidate hydrochloride Novartis Pharmaceuticals Corporation NDA Current 0078-0381 Focalin dexmethylphenidate hydrochloride Novartis Pharmaceuticals Corporation NDA Current 0078-0381 Focalin dexmethylphenidate hydrochloride Novartis Pharmaceuticals Corporation NDA Current 0078-0381 Focalin dexmethylphenidate hydrochloride Novartis Pharmaceuticals Corporation NDA Current 0078-0382 Focalin dexmethylphenidate hydrochloride Novartis Pharmaceuticals Corporation NDA Current 0078-0382 Focalin dexmethylphenidate hydrochloride Novartis Pharmaceuticals Corporation NDA Current 0078-0382 Focalin dexmethylphenidate hydrochloride Novartis Pharmaceuticals Corporation NDA Current 0078-0382 Focalin dexmethylphenidate hydrochloride Novartis Pharmaceuticals Corporation NDA Current 0078-0382 Focalin dexmethylphenidate hydrochloride Novartis Pharmaceuticals Corporation NDA Current 0078-0382 Focalin dexmethylphenidate hydrochloride Novartis Pharmaceuticals Corporation NDA Current 0078-0382 Focalin dexmethylphenidate hydrochloride Novartis Pharmaceuticals Corporation NDA Current 0781-5676 Dexmethylphenidate Hydrochloride Dexmethylphenidate Hydrochloride Sandoz Inc NDA AUTHORIZED GENERIC Current 0781-5676 Dexmethylphenidate Hydrochloride Dexmethylphenidate Hydrochloride Sandoz Inc NDA AUTHORIZED GENERIC Current 0781-5689 Dexmethylphenidate Hydrochloride Dexmethylphenidate Hydrochloride Sandoz Inc NDA AUTHORIZED GENERIC Current 0781-5689 Dexmethylphenidate Hydrochloride Dexmethylphenidate Hydrochloride Sandoz Inc NDA AUTHORIZED GENERIC Current 0781-5691 Dexmethylphenidate Hydrochloride Dexmethylphenidate Hydrochloride Sandoz Inc NDA AUTHORIZED GENERIC Current 0781-5691 Dexmethylphenidate Hydrochloride Dexmethylphenidate Hydrochloride Sandoz Inc NDA AUTHORIZED GENERIC Current