Application 202892

Type
ANDA
Sponsor
OXFORD PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001METHYLPHENIDATE HYDROCHLORIDEMETHYLPHENIDATE HYDROCHLORIDETABLET;ORAL5MGNoNo
002METHYLPHENIDATE HYDROCHLORIDEMETHYLPHENIDATE HYDROCHLORIDETABLET;ORAL10MGNoNo
003METHYLPHENIDATE HYDROCHLORIDEMETHYLPHENIDATE HYDROCHLORIDETABLET;ORAL20MGNoNo

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A202892-001METHYLPHENIDATE HYDROCHLORIDEMETHYLPHENIDATE HYDROCHLORIDE5MGTABLET / ORALAB2014-09-23
A202892-002METHYLPHENIDATE HYDROCHLORIDEMETHYLPHENIDATE HYDROCHLORIDE10MGTABLET / ORALAB2014-09-23
A202892-003METHYLPHENIDATE HYDROCHLORIDEMETHYLPHENIDATE HYDROCHLORIDE20MGTABLET / ORALAB2014-09-23

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
A202892-001AB
A202892-002AB
A202892-003AB

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 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A202892-001METHYLPHENIDATE HYDROCHLORIDE5MGTABLET / ORALAB2014-09-23011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202892-002METHYLPHENIDATE HYDROCHLORIDE10MGTABLET / ORALAB2014-09-23011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202892-003METHYLPHENIDATE HYDROCHLORIDE20MGTABLET / ORALAB2014-09-23011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202892-001METHYLPHENIDATE HYDROCHLORIDE5MGTABLET / ORALAB2014-09-2331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202892-002METHYLPHENIDATE HYDROCHLORIDE10MGTABLET / ORALAB2014-09-2331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202892-003METHYLPHENIDATE HYDROCHLORIDE20MGTABLET / ORALAB2014-09-2331067a03dcf5…
2025-08-23 18:47 UTC2025-08A202892-001METHYLPHENIDATE HYDROCHLORIDE5MGTABLET / ORALAB2014-09-236a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202892-002METHYLPHENIDATE HYDROCHLORIDE10MGTABLET / ORALAB2014-09-236a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202892-003METHYLPHENIDATE HYDROCHLORIDE20MGTABLET / ORALAB2014-09-236a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202892-001METHYLPHENIDATE HYDROCHLORIDE5MGTABLET / ORALAB2014-09-23fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202892-002METHYLPHENIDATE HYDROCHLORIDE10MGTABLET / ORALAB2014-09-23fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202892-003METHYLPHENIDATE HYDROCHLORIDE20MGTABLET / ORALAB2014-09-23fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202892-001METHYLPHENIDATE HYDROCHLORIDE5MGTABLET / ORALAB2014-09-23b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202892-002METHYLPHENIDATE HYDROCHLORIDE10MGTABLET / ORALAB2014-09-23b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202892-003METHYLPHENIDATE HYDROCHLORIDE20MGTABLET / ORALAB2014-09-23b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202892-001METHYLPHENIDATE HYDROCHLORIDE5MGTABLET / ORALAB2014-09-2303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202892-002METHYLPHENIDATE HYDROCHLORIDE10MGTABLET / ORALAB2014-09-2303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202892-003METHYLPHENIDATE HYDROCHLORIDE20MGTABLET / ORALAB2014-09-2303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202892-001METHYLPHENIDATE HYDROCHLORIDE5MGTABLET / ORALAB2014-09-232680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202892-002METHYLPHENIDATE HYDROCHLORIDE10MGTABLET / ORALAB2014-09-232680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202892-003METHYLPHENIDATE HYDROCHLORIDE20MGTABLET / ORALAB2014-09-232680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202892-001METHYLPHENIDATE HYDROCHLORIDE5MGTABLET / ORALAB2014-09-235bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202892-002METHYLPHENIDATE HYDROCHLORIDE10MGTABLET / ORALAB2014-09-235bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202892-003METHYLPHENIDATE HYDROCHLORIDE20MGTABLET / ORALAB2014-09-235bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202892-001METHYLPHENIDATE HYDROCHLORIDE5MGTABLET / ORALAB2014-09-23d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202892-002METHYLPHENIDATE HYDROCHLORIDE10MGTABLET / ORALAB2014-09-23d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202892-003METHYLPHENIDATE HYDROCHLORIDE20MGTABLET / ORALAB2014-09-23d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A202892-001METHYLPHENIDATE HYDROCHLORIDE5MGTABLET / ORALAB2014-09-23d06236e962d9…
2024-10-29 15:01 UTC2024-10A202892-002METHYLPHENIDATE HYDROCHLORIDE10MGTABLET / ORALAB2014-09-23d06236e962d9…
2024-10-29 15:01 UTC2024-10A202892-003METHYLPHENIDATE HYDROCHLORIDE20MGTABLET / ORALAB2014-09-23d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202892-001METHYLPHENIDATE HYDROCHLORIDE5MGTABLET / ORALAB2014-09-2379d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202892-002METHYLPHENIDATE HYDROCHLORIDE10MGTABLET / ORALAB2014-09-2379d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202892-003METHYLPHENIDATE HYDROCHLORIDE20MGTABLET / ORALAB2014-09-2379d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202892-001METHYLPHENIDATE HYDROCHLORIDE5MGTABLET / ORALAB2014-09-23301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202892-002METHYLPHENIDATE HYDROCHLORIDE10MGTABLET / ORALAB2014-09-23301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202892-003METHYLPHENIDATE HYDROCHLORIDE20MGTABLET / ORALAB2014-09-23301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A202892-001METHYLPHENIDATE HYDROCHLORIDE5MGTABLET / ORALAB2014-09-231e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A202892-002METHYLPHENIDATE HYDROCHLORIDE10MGTABLET / ORALAB2014-09-231e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A202892-003METHYLPHENIDATE HYDROCHLORIDE20MGTABLET / ORALAB2014-09-231e350fbaab3a…
2024-05-31 18:47 UTC2024-05A202892-001METHYLPHENIDATE HYDROCHLORIDE5MGTABLET / ORALAB2014-09-238072bd15b7f6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A202892-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202892-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202892-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202892-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202892-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202892-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A202892-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202892-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202892-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202892-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202892-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202892-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202892-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202892-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202892-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202892-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202892-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202892-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202892-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202892-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202892-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202892-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202892-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202892-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202892-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202892-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202892-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A202892-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A202892-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A202892-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202892-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202892-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202892-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202892-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202892-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202892-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A202892-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A202892-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A202892-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A202892-001AB18072bd15b7f6…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 5 · 81 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
METHYLPHENIDATE HYDROCHLORIDEMETHYLPHENIDATE HYDROCHLORIDEGranules Pharmaceuticals Inc.45d33807-88b2-4b42-9c86-e5b05d7adec12026-07-17Boxed warning, Warnings, Adverse reactionsName fallback
brand name: METHYLPHENIDATE HYDROCHLORIDE
generic name: METHYLPHENIDATE HYDROCHLORIDE
Methylphenidate HydrochlorideMETHYLPHENIDATE HYDROCHLORIDERhodes Pharmaceuticals LLCf7a7ffd1-bc30-4db8-8391-dddf76acd6392026-05-29Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Methylphenidate Hydrochloride
generic name: METHYLPHENIDATE HYDROCHLORIDE
Methylphenidate HydrochlorideMETHYLPHENIDATE HYDROCHLORIDELannett Company, Inc.44737c1d-fe75-409e-8a58-591696d3d7aa2026-05-28Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Methylphenidate Hydrochloride
generic name: METHYLPHENIDATE HYDROCHLORIDE
Methylphenidate HydrochlorideMETHYLPHENIDATE HYDROCHLORIDEAmneal Pharmaceuticals of New York LLC10aa0dc0-bd0e-4927-a19a-8722d78ad67d2026-05-27Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Methylphenidate Hydrochloride
generic name: METHYLPHENIDATE HYDROCHLORIDE
MethylphenidateMETHYLPHENIDATE HYDROCHLORIDEKVK-Tech, Inc.2cf1b26b-199d-4c7f-ab64-4805a9def2cc2026-05-11Boxed warning, Warnings, Adverse reactionsName fallback
generic name: METHYLPHENIDATE HYDROCHLORIDE
Methylphenidate HydrochlorideMETHYLPHENIDATE HYDROCHLORIDELannett Company, Inc.3d1f5aff-5d39-496c-b5ed-7f3c70ec641c2026-05-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Methylphenidate Hydrochloride
generic name: METHYLPHENIDATE HYDROCHLORIDE
Methylphenidate HydrochlorideMETHYLPHENIDATE HYDROCHLORIDEActavis Pharma, Inc.85ef422d-af27-4126-9841-6892af1871d62026-04-30Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Methylphenidate Hydrochloride
generic name: METHYLPHENIDATE HYDROCHLORIDE
Methylphenidate HydrochlorideMETHYLPHENIDATE HYDROCHLORIDETrigen Laboratories, LLCc45dc1de-adfa-4b3c-a7dc-cffbc8eac74f2026-04-24Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Methylphenidate Hydrochloride
generic name: METHYLPHENIDATE HYDROCHLORIDE
Methylphenidate HydrochlorideMETHYLPHENIDATE HYDROCHLORIDESun Pharmaceutical Industries, Inc.18024571-4505-6d51-e063-6294a90a19722026-04-24Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Methylphenidate Hydrochloride
generic name: METHYLPHENIDATE HYDROCHLORIDE
METHYLPHENIDATE HYDROCHLORIDEMETHYLPHENIDATE HYDROCHLORIDEGolden State Medical Supply, Inc.98be5c84-b348-6b8e-e053-2995a90ae4cc2026-04-23Boxed warning, Warnings, Adverse reactionsName fallback
brand name: METHYLPHENIDATE HYDROCHLORIDE
generic name: METHYLPHENIDATE HYDROCHLORIDE
Methylphenidate HydrochlorideMETHYLPHENIDATE HYDROCHLORIDEGolden State Medical Supply, Inc.22e5ddfa-7264-fbb1-e063-6394a90a64832026-04-23Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Methylphenidate Hydrochloride
generic name: METHYLPHENIDATE HYDROCHLORIDE
CONCERTAMETHYLPHENIDATE HYDROCHLORIDEJanssen Pharmaceuticals, Inc.1a88218c-5b18-4220-8f56-526de1a276cd2026-04-20Boxed warning, Warnings, Adverse reactionsName fallback
generic name: METHYLPHENIDATE HYDROCHLORIDE
QuilliChew ERMETHYLPHENIDATE HYDROCHLORIDENextWave Pharmaceuticals, Incdefc1205-8e90-4b1e-b862-05e4c35c73642026-04-08Boxed warning, Warnings, Adverse reactionsName fallback
generic name: METHYLPHENIDATE HYDROCHLORIDE
Methylphenidate HydrochlorideMETHYLPHENIDATE HYDROCHLORIDENorthstar Rx LLC768bf181-d0d8-49e5-9c87-cacbb069e0b22026-04-02Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Methylphenidate Hydrochloride
generic name: METHYLPHENIDATE HYDROCHLORIDE
Quillivant XRMETHYLPHENIDATE HYDROCHLORIDENextWave Pharmaceuticals, Incc2dc2109-44a6-4797-b04e-18761dd9d45a2026-03-24Boxed warning, Warnings, Adverse reactionsName fallback
generic name: METHYLPHENIDATE HYDROCHLORIDE
Methylphenidate HydrochlorideMETHYLPHENIDATE HYDROCHLORIDEBryant Ranch Prepackcd2c1226-fa19-4734-b62d-89fea73dcb0d2026-03-17Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Methylphenidate Hydrochloride
generic name: METHYLPHENIDATE HYDROCHLORIDE
Methylphenidate HydrochlorideMETHYLPHENIDATE HYDROCHLORIDEBryant Ranch Prepack5a29687b-5294-4b27-a556-514b092a877d2026-03-17Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Methylphenidate Hydrochloride
generic name: METHYLPHENIDATE HYDROCHLORIDE
Methylphenidate HydrochlorideMETHYLPHENIDATE HYDROCHLORIDEKVK-TECH, INC.1bf37f9f-29cf-4b09-9c81-eb369e35a0422026-01-02Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Methylphenidate Hydrochloride
generic name: METHYLPHENIDATE HYDROCHLORIDE
Methylphenidate HydrochlorideMETHYLPHENIDATE HYDROCHLORIDEAmerican Health Packagingf6581305-cd1e-4171-8c1b-e184c7bde0332025-12-04Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Methylphenidate Hydrochloride
generic name: METHYLPHENIDATE HYDROCHLORIDE
Methylphenidate Hydrochloride Extended-ReleaseMETHYLPHENIDATE HYDROCHLORIDESpecGx LLC9e11e093-4ff3-4bed-8fe9-3ee460b473032025-12-01Boxed warning, Warnings, Adverse reactionsName fallback
generic name: METHYLPHENIDATE HYDROCHLORIDE

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 6 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0603-4576Methylphenidate Hydrochloridemethylphenidate hydrochloridePar PharmaceuticalANDACurrent
0603-4576Methylphenidate Hydrochloridemethylphenidate hydrochloridePar PharmaceuticalANDACurrent
0603-4577Methylphenidate Hydrochloridemethylphenidate hydrochloridePar PharmaceuticalANDACurrent
0603-4577Methylphenidate Hydrochloridemethylphenidate hydrochloridePar PharmaceuticalANDACurrent
0603-4578Methylphenidate Hydrochloridemethylphenidate hydrochloridePar PharmaceuticalANDACurrent
0603-4578Methylphenidate Hydrochloridemethylphenidate hydrochloridePar PharmaceuticalANDACurrent