FDA.reportPublic FDA data

Application 206932

Type
ANDA
Sponsor
ABHAI 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 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
A206932-001METHYLPHENIDATE HYDROCHLORIDEMETHYLPHENIDATE HYDROCHLORIDE5MGTABLET / ORALAB2017-05-11
A206932-002METHYLPHENIDATE HYDROCHLORIDEMETHYLPHENIDATE HYDROCHLORIDE10MGTABLET / ORALAB2017-05-11
A206932-003METHYLPHENIDATE HYDROCHLORIDEMETHYLPHENIDATE HYDROCHLORIDE20MGTABLET / ORALAB2017-05-11

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A206932-001AB
A206932-002AB
A206932-003AB

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A206932-001METHYLPHENIDATE HYDROCHLORIDE5MGTABLET / ORALAB2017-05-11a50c72e98297…
2026-08-01 22:54:322026-06A206932-002METHYLPHENIDATE HYDROCHLORIDE10MGTABLET / ORALAB2017-05-11a50c72e98297…
2026-08-01 22:54:322026-06A206932-003METHYLPHENIDATE HYDROCHLORIDE20MGTABLET / ORALAB2017-05-11a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A206932-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A206932-002AB1a50c72e98297…
2026-08-01 22:54:322026-06A206932-003AB1a50c72e98297…

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 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Methylphenidate HydrochlorideMETHYLPHENIDATE HYDROCHLORIDEKVK-TECH, INC.1bf37f9f-29cf-4b09-9c81-eb369e35a0422026-01-02Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206932
application number: ANDA206932
ndc (product): 10702-102
ndc (product): 10702-101
ndc (product): 10702-100

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 9 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
10702-100Methylphenidate HydrochlorideMethylphenidate HydrochlorideKVK-TECH, INC.ANDACurrent
10702-100Methylphenidate HydrochlorideMethylphenidate HydrochlorideKVK-TECH, INC.ANDACurrent
10702-100Methylphenidate HydrochlorideMethylphenidate HydrochlorideKVK-TECH, INC.ANDACurrent
10702-101Methylphenidate HydrochlorideMethylphenidate HydrochlorideKVK-TECH, INC.ANDACurrent
10702-101Methylphenidate HydrochlorideMethylphenidate HydrochlorideKVK-TECH, INC.ANDACurrent
10702-101Methylphenidate HydrochlorideMethylphenidate HydrochlorideKVK-TECH, INC.ANDACurrent
10702-102Methylphenidate HydrochlorideMethylphenidate HydrochlorideKVK-TECH, INC.ANDACurrent
10702-102Methylphenidate HydrochlorideMethylphenidate HydrochlorideKVK-TECH, INC.ANDACurrent
10702-102Methylphenidate HydrochlorideMethylphenidate HydrochlorideKVK-TECH, INC.ANDACurrent