FDA.reportPublic FDA data

Application 201501

Type
ANDA
Sponsor
XIROMED

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ACYCLOVIRACYCLOVIROINTMENT;TOPICAL5%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
A201501-001ACYCLOVIRACYCLOVIR5%OINTMENT / TOPICALAB2020-01-29

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A201501-001AB

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 22:54:322026-06A201501-001ACYCLOVIR5%OINTMENT / TOPICALAB2020-01-29a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A201501-001AB1a50c72e98297…

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
AcyclovirACYCLOVIRBryant Ranch Prepacka4c15f29-313f-49ca-acfa-c0e6910f64fb2024-01-25Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201501
application number: ANDA201501
AcyclovirACYCLOVIRBryant Ranch Prepacke2b2c88a-84d2-42e6-ad18-819f7e78dbd62024-01-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201501
application number: ANDA201501
ndc (product): 63629-2328
AcyclovirACYCLOVIRBryant Ranch Prepackd04c696f-c072-46f7-9a92-9cbb476c827b2024-01-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201501
application number: ANDA201501
ndc (product): 63629-2327
AcyclovirACYCLOVIRXiromed, LLC3e222423-3bf2-6584-6d54-447b1b26dc422020-01-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201501
application number: ANDA201501
ndc (product): 70700-107

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 7 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
63629-2327AcyclovirAcyclovirBryant Ranch PrepackANDACurrent
63629-2327AcyclovirAcyclovirBryant Ranch PrepackANDACurrent
63629-2328AcyclovirAcyclovirBryant Ranch PrepackANDACurrent
63629-2328AcyclovirAcyclovirBryant Ranch PrepackANDACurrent
70700-107AcyclovirAcyclovirXiromed, LLCANDACurrent
70700-107AcyclovirAcyclovirXiromed, LLCANDACurrent
70700-107AcyclovirAcyclovirXiromed, LLCANDACurrent