Application 207416

Type
ANDA
Sponsor
ASCENT PHARMS INC

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 42.

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
A207416-001METHYLPHENIDATE HYDROCHLORIDEMETHYLPHENIDATE HYDROCHLORIDE5MGTABLET / ORALAB2015-09-22
A207416-002METHYLPHENIDATE HYDROCHLORIDEMETHYLPHENIDATE HYDROCHLORIDE10MGTABLET / ORALAB2015-09-22
A207416-003METHYLPHENIDATE HYDROCHLORIDEMETHYLPHENIDATE HYDROCHLORIDE20MGTABLET / ORALAB2015-09-22

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A207416-001AB
A207416-002AB
A207416-003AB

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 · 126 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A207416-001METHYLPHENIDATE HYDROCHLORIDE5MGTABLET / ORALAB2015-09-22caaa826d4ba7…
2026-08-18 06:07:402026-07A207416-002METHYLPHENIDATE HYDROCHLORIDE10MGTABLET / ORALAB2015-09-22caaa826d4ba7…
2026-08-18 06:07:402026-07A207416-003METHYLPHENIDATE HYDROCHLORIDE20MGTABLET / ORALAB2015-09-22caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A207416-001METHYLPHENIDATE HYDROCHLORIDE5MGTABLET / ORALAB2015-09-22011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207416-002METHYLPHENIDATE HYDROCHLORIDE10MGTABLET / ORALAB2015-09-22011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207416-003METHYLPHENIDATE HYDROCHLORIDE20MGTABLET / ORALAB2015-09-22011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207416-001METHYLPHENIDATE HYDROCHLORIDE5MGTABLET / ORALAB2015-09-2231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207416-002METHYLPHENIDATE HYDROCHLORIDE10MGTABLET / ORALAB2015-09-2231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207416-003METHYLPHENIDATE HYDROCHLORIDE20MGTABLET / ORALAB2015-09-2231067a03dcf5…
2025-08-23 18:47 UTC2025-08A207416-001METHYLPHENIDATE HYDROCHLORIDE5MGTABLET / ORALAB2015-09-226a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207416-002METHYLPHENIDATE HYDROCHLORIDE10MGTABLET / ORALAB2015-09-226a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207416-003METHYLPHENIDATE HYDROCHLORIDE20MGTABLET / ORALAB2015-09-226a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207416-001METHYLPHENIDATE HYDROCHLORIDE5MGTABLET / ORALAB2015-09-22fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207416-002METHYLPHENIDATE HYDROCHLORIDE10MGTABLET / ORALAB2015-09-22fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207416-003METHYLPHENIDATE HYDROCHLORIDE20MGTABLET / ORALAB2015-09-22fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207416-001METHYLPHENIDATE HYDROCHLORIDE5MGTABLET / ORALAB2015-09-22b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207416-002METHYLPHENIDATE HYDROCHLORIDE10MGTABLET / ORALAB2015-09-22b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207416-003METHYLPHENIDATE HYDROCHLORIDE20MGTABLET / ORALAB2015-09-22b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207416-001METHYLPHENIDATE HYDROCHLORIDE5MGTABLET / ORALAB2015-09-2203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207416-002METHYLPHENIDATE HYDROCHLORIDE10MGTABLET / ORALAB2015-09-2203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207416-003METHYLPHENIDATE HYDROCHLORIDE20MGTABLET / ORALAB2015-09-2203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207416-001METHYLPHENIDATE HYDROCHLORIDE5MGTABLET / ORALAB2015-09-222680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207416-002METHYLPHENIDATE HYDROCHLORIDE10MGTABLET / ORALAB2015-09-222680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207416-003METHYLPHENIDATE HYDROCHLORIDE20MGTABLET / ORALAB2015-09-222680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207416-001METHYLPHENIDATE HYDROCHLORIDE5MGTABLET / ORALAB2015-09-225bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207416-002METHYLPHENIDATE HYDROCHLORIDE10MGTABLET / ORALAB2015-09-225bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207416-003METHYLPHENIDATE HYDROCHLORIDE20MGTABLET / ORALAB2015-09-225bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207416-001METHYLPHENIDATE HYDROCHLORIDE5MGTABLET / ORALAB2015-09-22d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207416-002METHYLPHENIDATE HYDROCHLORIDE10MGTABLET / ORALAB2015-09-22d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207416-003METHYLPHENIDATE HYDROCHLORIDE20MGTABLET / ORALAB2015-09-22d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A207416-001METHYLPHENIDATE HYDROCHLORIDE5MGTABLET / ORALAB2015-09-22d06236e962d9…
2024-10-29 15:01 UTC2024-10A207416-002METHYLPHENIDATE HYDROCHLORIDE10MGTABLET / ORALAB2015-09-22d06236e962d9…
2024-10-29 15:01 UTC2024-10A207416-003METHYLPHENIDATE HYDROCHLORIDE20MGTABLET / ORALAB2015-09-22d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A207416-001METHYLPHENIDATE HYDROCHLORIDE5MGTABLET / ORALAB2015-09-2279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A207416-002METHYLPHENIDATE HYDROCHLORIDE10MGTABLET / ORALAB2015-09-2279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A207416-003METHYLPHENIDATE HYDROCHLORIDE20MGTABLET / ORALAB2015-09-2279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A207416-001METHYLPHENIDATE HYDROCHLORIDE5MGTABLET / ORALAB2015-09-22301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A207416-002METHYLPHENIDATE HYDROCHLORIDE10MGTABLET / ORALAB2015-09-22301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A207416-003METHYLPHENIDATE HYDROCHLORIDE20MGTABLET / ORALAB2015-09-22301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A207416-001METHYLPHENIDATE HYDROCHLORIDE5MGTABLET / ORALAB2015-09-221e350fbaab3a…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 126 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A207416-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A207416-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A207416-003AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A207416-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207416-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207416-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207416-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207416-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207416-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A207416-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207416-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207416-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207416-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207416-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207416-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207416-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207416-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207416-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207416-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207416-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207416-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207416-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207416-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207416-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207416-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207416-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207416-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207416-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207416-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207416-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A207416-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A207416-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A207416-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A207416-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A207416-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A207416-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A207416-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A207416-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A207416-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A207416-001AB11e350fbaab3a…

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 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
METHYLPHENIDATE HYDROCHLORIDEMETHYLPHENIDATE HYDROCHLORIDECamber Pharmaceutical Inc778190da-1528-4def-94bf-ee23ee5268a52025-08-06Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207416
application number: ANDA207416
ndc (product): 31722-175
ndc (product): 31722-173
ndc (product): 31722-174
METHYLPHENIDATE HYDROCHLORIDEMETHYLPHENIDATE HYDROCHLORIDEBryant Ranch Prepackec3d9304-13bc-4f0b-bf14-1a1ea824bd912024-10-31Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207416
application number: ANDA207416
ndc (product): 71335-1219
METHYLPHENIDATE HYDROCHLORIDEMETHYLPHENIDATE HYDROCHLORIDEXLCare Pharmaceuticals Inc94dc74d4-b4ef-45bc-b502-54ec692e9bd52021-08-18Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207416
application number: ANDA207416
ndc (product): 72865-124
ndc (product): 72865-122
ndc (product): 72865-123

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 46 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
16714-821METHYLPHENIDATE HYDROCHLORIDEMETHYLPHENIDATE HYDROCHLORIDENorthstar Rx LLCANDACurrent
16714-821METHYLPHENIDATE HYDROCHLORIDEMETHYLPHENIDATE HYDROCHLORIDENorthstar Rx LLCANDACurrent
16714-821METHYLPHENIDATE HYDROCHLORIDEMETHYLPHENIDATE HYDROCHLORIDENorthstar Rx LLCANDACurrent
16714-821METHYLPHENIDATE HYDROCHLORIDEMETHYLPHENIDATE HYDROCHLORIDENorthStar Rx LLCANDACurrent
16714-822METHYLPHENIDATE HYDROCHLORIDEMETHYLPHENIDATE HYDROCHLORIDENorthstar Rx LLCANDACurrent
16714-822METHYLPHENIDATE HYDROCHLORIDEMETHYLPHENIDATE HYDROCHLORIDENorthstar Rx LLCANDACurrent
16714-822METHYLPHENIDATE HYDROCHLORIDEMETHYLPHENIDATE HYDROCHLORIDENorthstar Rx LLCANDACurrent
16714-822METHYLPHENIDATE HYDROCHLORIDEMETHYLPHENIDATE HYDROCHLORIDENorthStar Rx LLCANDACurrent
16714-823METHYLPHENIDATE HYDROCHLORIDEMETHYLPHENIDATE HYDROCHLORIDENorthstar Rx LLCANDACurrent
16714-823METHYLPHENIDATE HYDROCHLORIDEMETHYLPHENIDATE HYDROCHLORIDENorthstar Rx LLCANDACurrent
16714-823METHYLPHENIDATE HYDROCHLORIDEMETHYLPHENIDATE HYDROCHLORIDENorthstar Rx LLCANDACurrent
16714-823METHYLPHENIDATE HYDROCHLORIDEMETHYLPHENIDATE HYDROCHLORIDENorthStar Rx LLCANDACurrent
31722-173METHYLPHENIDATE HYDROCHLORIDEMETHYLPHENIDATE HYDROCHLORIDECamber Pharmaceutical IncANDACurrent
31722-173METHYLPHENIDATE HYDROCHLORIDEMETHYLPHENIDATE HYDROCHLORIDECamber Pharmaceutical IncANDACurrent
31722-173METHYLPHENIDATE HYDROCHLORIDEMETHYLPHENIDATE HYDROCHLORIDECamber Pharmaceutical IncANDACurrent
31722-173METHYLPHENIDATE HYDROCHLORIDEMETHYLPHENIDATE HYDROCHLORIDECamber Pharmaceuticals Inc.ANDACurrent
31722-174METHYLPHENIDATE HYDROCHLORIDEMETHYLPHENIDATE HYDROCHLORIDECamber Pharmaceutical IncANDACurrent
31722-174METHYLPHENIDATE HYDROCHLORIDEMETHYLPHENIDATE HYDROCHLORIDECamber Pharmaceutical IncANDACurrent
31722-174METHYLPHENIDATE HYDROCHLORIDEMETHYLPHENIDATE HYDROCHLORIDECamber Pharmaceutical IncANDACurrent
31722-174METHYLPHENIDATE HYDROCHLORIDEMETHYLPHENIDATE HYDROCHLORIDECamber Pharmaceuticals Inc.ANDACurrent
31722-175METHYLPHENIDATE HYDROCHLORIDEMETHYLPHENIDATE HYDROCHLORIDECamber Pharmaceutical IncANDACurrent
31722-175METHYLPHENIDATE HYDROCHLORIDEMETHYLPHENIDATE HYDROCHLORIDECamber Pharmaceutical IncANDACurrent
31722-175METHYLPHENIDATE HYDROCHLORIDEMETHYLPHENIDATE HYDROCHLORIDECamber Pharmaceutical IncANDACurrent
31722-175METHYLPHENIDATE HYDROCHLORIDEMETHYLPHENIDATE HYDROCHLORIDECamber Pharmaceuticals Inc.ANDACurrent
50268-528METHYLPHENIDATE HYDROCHLORIDEMETHYLPHENIDATE HYDROCHLORIDEAvPAKANDACurrent
50268-528METHYLPHENIDATE HYDROCHLORIDEMETHYLPHENIDATE HYDROCHLORIDEAvPAKANDACurrent
50268-529METHYLPHENIDATE HYDROCHLORIDEMETHYLPHENIDATE HYDROCHLORIDEAvPAKANDACurrent
50268-529METHYLPHENIDATE HYDROCHLORIDEMETHYLPHENIDATE HYDROCHLORIDEAvPAKANDACurrent
50268-529METHYLPHENIDATE HYDROCHLORIDEMETHYLPHENIDATE HYDROCHLORIDEAvPAKANDACurrent
63629-1920METHYLPHENIDATE HYDROCHLORIDEMETHYLPHENIDATE HYDROCHLORIDEBryant Ranch PrepackANDACurrent
63629-1920METHYLPHENIDATE HYDROCHLORIDEMETHYLPHENIDATE HYDROCHLORIDEBryant Ranch PrepackANDACurrent
63629-1920METHYLPHENIDATE HYDROCHLORIDEMETHYLPHENIDATE HYDROCHLORIDEBryant Ranch PrepackANDACurrent
63629-1922METHYLPHENIDATE HYDROCHLORIDEMETHYLPHENIDATE HYDROCHLORIDEBryant Ranch PrepackANDACurrent
63629-1922METHYLPHENIDATE HYDROCHLORIDEMETHYLPHENIDATE HYDROCHLORIDEBryant Ranch PrepackANDACurrent
63629-1922METHYLPHENIDATE HYDROCHLORIDEMETHYLPHENIDATE HYDROCHLORIDEBryant Ranch PrepackANDACurrent
63629-1924METHYLPHENIDATE HYDROCHLORIDEMETHYLPHENIDATE HYDROCHLORIDEBryant Ranch PrepackANDACurrent
63629-1924METHYLPHENIDATE HYDROCHLORIDEMETHYLPHENIDATE HYDROCHLORIDEBryant Ranch PrepackANDACurrent
63629-1924METHYLPHENIDATE HYDROCHLORIDEMETHYLPHENIDATE HYDROCHLORIDEBryant Ranch PrepackANDACurrent
71335-1219METHYLPHENIDATE HYDROCHLORIDEMETHYLPHENIDATE HYDROCHLORIDEBryant Ranch PrepackANDACurrent
71335-1219METHYLPHENIDATE HYDROCHLORIDEMETHYLPHENIDATE HYDROCHLORIDEBryant Ranch PrepackANDACurrent
72865-122METHYLPHENIDATE HYDROCHLORIDEMETHYLPHENIDATE HYDROCHLORIDEXLCare Pharmaceuticals IncANDACurrent
72865-122METHYLPHENIDATE HYDROCHLORIDEMETHYLPHENIDATE HYDROCHLORIDEXLCare Pharmaceuticals IncANDACurrent
72865-123METHYLPHENIDATE HYDROCHLORIDEMETHYLPHENIDATE HYDROCHLORIDEXLCare Pharmaceuticals IncANDACurrent
72865-123METHYLPHENIDATE HYDROCHLORIDEMETHYLPHENIDATE HYDROCHLORIDEXLCare Pharmaceuticals IncANDACurrent
72865-124METHYLPHENIDATE HYDROCHLORIDEMETHYLPHENIDATE HYDROCHLORIDEXLCare Pharmaceuticals IncANDACurrent
72865-124METHYLPHENIDATE HYDROCHLORIDEMETHYLPHENIDATE HYDROCHLORIDEXLCare Pharmaceuticals IncANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
10616ORIG2015-09-24