FDA.reportPublic FDA data

Application 206633

Type
ANDA
Sponsor
FOUGERA PHARMS INC

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
A206633-001ACYCLOVIRACYCLOVIR5%OINTMENT / TOPICALAB2016-05-11

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A206633-001AB

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 22:54:322026-06A206633-001ACYCLOVIR5%OINTMENT / TOPICALAB2016-05-11a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A206633-001AB1a50c72e98297…

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 9 · 178 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
acyclovirACYCLOVIRPD-Rx Pharmaceuticals, Inc.86c43bdf-c5bf-47cd-8dfd-8112638258782026-07-24Warnings, Adverse reactionsName fallback
brand name: acyclovir
generic name: ACYCLOVIR
AcyclovirACYCLOVIRREMEDYREPACK INC.6d0e492e-5359-49e8-812d-8c8e2e5d42f82026-07-24Warnings, Adverse reactionsName fallback
brand name: Acyclovir
generic name: ACYCLOVIR
AcyclovirACYCLOVIRREMEDYREPACK INC.736679be-469e-4bdb-8e15-b10751c3dd602026-07-24Warnings, Adverse reactionsName fallback
brand name: Acyclovir
generic name: ACYCLOVIR
AcyclovirACYCLOVIRREMEDYREPACK INC.38547daa-7d2f-4a7b-84d3-6e164984f9582026-07-17Warnings, Adverse reactionsName fallback
brand name: Acyclovir
generic name: ACYCLOVIR
ACYCLOVIRACYCLOVIRMajor Pharmaceuticals9b254eed-8ea1-469b-bf27-f5670cd99e8d2026-07-14Warnings, Adverse reactionsName fallback
brand name: ACYCLOVIR
generic name: ACYCLOVIR
AcyclovirACYCLOVIRATLANTIC BIOLOGICALS CORP.da5a809c-6ddc-4609-9a34-ccb3d2d439762026-07-10Warnings, Adverse reactionsName fallback
brand name: Acyclovir
generic name: ACYCLOVIR
ACYCLOVIRACYCLOVIRHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.85332671-0e3a-4445-a337-e1266886b9cf2026-07-08Warnings, Adverse reactionsName fallback
brand name: ACYCLOVIR
generic name: ACYCLOVIR
acyclovirACYCLOVIRREMEDYREPACK INC.499c6a98-0614-4ded-8526-909942bae8a42026-06-26Warnings, Adverse reactionsName fallback
brand name: acyclovir
generic name: ACYCLOVIR
AcyclovirACYCLOVIRREMEDYREPACK INC.37a51d9c-1f39-4065-8c7d-6528ac6de91c2026-06-23Warnings, Adverse reactionsName fallback
brand name: Acyclovir
generic name: ACYCLOVIR
ACYCLOVIRACYCLOVIRAlembic Pharmaceuticals Inc.878615c2-09ea-44ce-8c30-7a7f16acb20c2026-06-18Warnings, Adverse reactionsName fallback
brand name: ACYCLOVIR
generic name: ACYCLOVIR
acyclovirACYCLOVIRBryant Ranch Prepackdb35fce0-d7a3-4589-ba60-d78cdb1119cb2026-06-18Warnings, Adverse reactionsName fallback
brand name: acyclovir
generic name: ACYCLOVIR
AcyclovirACYCLOVIRRedpharm Drug53cbca4d-3ddc-b11e-e063-6394a90a04fa2026-06-09Warnings, Adverse reactionsName fallback
brand name: Acyclovir
generic name: ACYCLOVIR
AcyclovirACYCLOVIRSt. Mary's Medical Park Pharmacy1493e22d-455d-b613-e063-6294a90afede2026-06-04Warnings, Adverse reactionsName fallback
brand name: Acyclovir
generic name: ACYCLOVIR
AcyclovirACYCLOVIRBryant Ranch Prepackdbdb7903-0991-413d-b1ad-ab0f1ae2d8f42026-06-04Warnings, Adverse reactionsName fallback
brand name: Acyclovir
generic name: ACYCLOVIR
AcyclovirACYCLOVIRPD-Rx Pharmaceuticals, Inc.db0a0ce5-dc39-4bd3-8b97-21ce9c9999f02026-05-27Warnings, Adverse reactionsName fallback
brand name: Acyclovir
generic name: ACYCLOVIR
ACYCLOVIRACYCLOVIRBryant Ranch Prepack2b600b5d-ce91-461f-b9d1-75b969daf8e92026-05-21Warnings, Adverse reactionsName fallback
brand name: ACYCLOVIR
generic name: ACYCLOVIR
AcyclovirACYCLOVIRBryant Ranch Prepack0e78d5e8-ae2d-4e84-b8c2-6765b1299c122026-05-21Warnings, Adverse reactionsName fallback
brand name: Acyclovir
generic name: ACYCLOVIR
ACYCLOVIRACYCLOVIRCardinal Health 107, LLC4cc7d67f-35fa-4238-a581-4810645083cf2026-05-14Warnings, Adverse reactionsName fallback
brand name: ACYCLOVIR
generic name: ACYCLOVIR
AcyclovirACYCLOVIRWestminster Pharmaceuticals, LLCf352a641-988e-4878-8016-2b69cd6ee5482026-05-11Warnings, Adverse reactionsName fallback
brand name: Acyclovir
generic name: ACYCLOVIR
ACYCLOVIRACYCLOVIRMajor Pharmaceuticals864d96b9-e2de-45a8-850b-6f7b72ceefe12026-05-04Warnings, Adverse reactionsName fallback
brand name: ACYCLOVIR
generic name: ACYCLOVIR

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 3 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0168-0825acycloviracyclovirE. Fougera & Co. a division of Fougera Pharmaceuticals Inc.ANDACurrent
0168-0825acycloviracyclovirE. Fougera & Co. a division of Fougera Pharmaceuticals Inc.ANDACurrent
0168-0825acycloviracyclovirE. Fougera & Co. a division of Fougera Pharmaceuticals Inc.ANDACurrent