FDA.reportPublic FDA data

Application 210835

Type
ANDA
Sponsor
XIROMED

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001TESTOSTERONETESTOSTERONEGEL, METERED;TRANSDERMAL1.62% (20.25MG/1.25GM ACTUATION)NoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A210835-001TESTOSTERONETESTOSTERONE1.62% (20.25MG/1.25GM ACTUATION)GEL, METERED / TRANSDERMALAB2020-04-16

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A210835-001AB

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 22:54:322026-06A210835-001TESTOSTERONE1.62% (20.25MG/1.25GM ACTUATION)GEL, METERED / TRANSDERMALAB2020-04-16a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A210835-001AB1a50c72e98297…

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 · 4 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TestosteroneTESTOSTERONENorthstar Rx LLC65981b8a-d5cc-1964-7eac-a07f032c25712026-06-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210835
application number: ANDA210835
TestosteroneTESTOSTERONEXiromed, LLC28e8d504-5073-1d78-f351-bcb7c5188ee62026-05-12Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210835
application number: ANDA210835
ndc (product): 70700-112
TestosteroneTESTOSTERONEBryant Ranch Prepackc6c0a39e-0e75-4356-a052-c26c30c76b262025-11-04Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210835
application number: ANDA210835
TestosteroneTESTOSTERONEBryant Ranch Prepack6c7d2dec-6492-4d53-b110-61ffeae9ee612025-09-03Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210835
application number: ANDA210835
ndc (product): 63629-2352

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 5 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
63629-2352TestosteroneTestosteroneBryant Ranch PrepackANDACurrent
63629-2352TestosteroneTestosteroneBryant Ranch PrepackANDACurrent
63629-2352TestosteroneTestosteroneBryant Ranch PrepackANDACurrent
70700-112TestosteroneTestosteroneXiromed, LLCANDACurrent
70700-112TestosteroneTestosteroneXiromed, LLCANDACurrent