FDA.reportPublic FDA data

Application 205659

Type
ANDA
Sponsor
PERRIGO UK FINCO

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ACYCLOVIRACYCLOVIROINTMENT;TOPICAL5%NoNo

Orange Book products#

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A205659-001ACYCLOVIRACYCLOVIR5%OINTMENT / TOPICAL2019-02-20

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.

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

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

warnings

WARNINGS Acyclovir Capsules are intended for oral ingestion only. Renal failure, in some cases resulting in death, has been observed with acyclovir therapy ( see ADVERSE REACTIONS: Observed During Clinical Practice and OVERDOSAGE ). Thrombotic thrombocytopenic purpura/hemolytic uremic syndrome (TTP/HUS), which has resulted in death, has occurred in immunocompromised patients receiving acyclovir therapy.

Adverse reactions cross-check#

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adverse reactions

ADVERSE REACTIONS Herpes Simplex: Short-Term Administration: The most frequent adverse events reported during clinical trials of treatment of genital herpes with acyclovir 200 mg administered orally 5 times daily every 4 hours for 10 days were nausea and/or vomiting in 8 of 298 patient treatments (2.7%). Nausea and/or vomiting occurred in 2 of 287 (0.7%) patients who received placebo. Long-Term Administration: The most frequent adverse events reported in a clinical trial for the prevention of recurrences with continuous administration of 400 mg (two 200-mg capsules) 2 times daily for 1 year in 586 patients treated with acyclovir were nausea (4.8%) and diarrhea (2.4%). The 589 control patients receiving intermittent treatment of recurrences with acyclovir for 1 year reported diarrhea (2.7%), nausea (2.4%) and headache (2.2%). Herpes Zoster: The most frequent adverse event reported during 3 clinical trials of treatment of herpes zoster (shingles) with 800 mg of oral acyclovir 5 times daily for 7 to 10 days in 323 patients was malaise (11.5%). The 323 placebo recipients reported malaise (11.1%). Chickenpox: The most frequent adverse event reported during 3 clinical trials of treatment of chickenpox with oral acyclovir at doses of 10 to 20 mg/kg 4 times daily for 5 to 7 days or 800 mg 4 times daily for 5 days in 495 patients was diarrhea (3.2%). The 498 patients receiving placebo reported diarrhea (2.2%). Observed During Clinical Practice: In addition to adverse events reported from clinical trials, the following events have been identified during post-approval use of acyclovir. Because they are reported voluntarily from a population of unknown size, estimates of frequency cannot be made. These events have been chosen for inclusion due to either their seriousness, frequency of reporting, potential causal connection to acyclovir, or a combination of these factors. General: Anaphylaxis, angioedema, fever, headache, pain, peripheral edema. Nervous: Aggressive behavior, agitation, ataxia, coma, confusion, decreased consciousness, delirium, dizziness, dysarthria, encephalopathy, hallucinations, paresthesia, psychosis, seizure, somnolence, tremors. These symptoms may be marked, particularly in older adults or in patients with renal impairment ( see PRECAUTIONS ). Digestive: Diarrhea, gastrointestinal distress, nausea. Hematologic and Lymphatic: Anemia, leukocytocla...