FDA.reportPublic FDA data

Application 064101

Type
ANDA
Sponsor
HI TECH PHARMA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ERYTHRO-STATINERYTHROMYCINSOLUTION;TOPICAL2%NoNo

Orange Book products#

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A064101-001ERYTHRO-STATINERYTHROMYCIN2%SOLUTION / TOPICAL1996-10-22

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
ErythromycinERYTHROMYCINSportpharm LLC790d3e3e-df69-45f7-97d5-da65faa465562026-07-21Adverse reactionsName fallback
ErythromycinERYTHROMYCINNuCare Pharmaceuticals,Inc.50c8d6b3-4660-e829-e063-6294a90a919b2026-05-01Adverse reactionsName fallback
ErythromycinERYTHROMYCINCardinal Health 107, LLCba4f06c3-ebce-4896-a5cc-59bb5c2cb4e52026-04-27Adverse reactionsName fallback
ErythromycinERYTHROMYCINGolden State Medical Supply, Inc.0c05e1f7-a3d4-8e69-e063-6394a90aecc32026-04-21Warnings, Adverse reactionsName fallback
ErythromycinERYTHROMYCINPreferred Pharmaceuticals, Inc.ee3d806e-65ce-42e1-b170-7b35bcb7b06a2026-04-10Adverse reactionsName fallback
ErythromycinERYTHROMYCINSentiss Pharmaceuticals LLC4da0e351-383f-55da-e063-6394a90a8eba2026-03-31Adverse reactionsName fallback
ERYTHROMYCINERYTHROMYCINDirect Rx9ac4dcd2-8cac-404d-b651-da74062d30ed2026-03-17Adverse reactionsName fallback
ErythromycinERYTHROMYCINTorrent Pharmaceuticals Limited933049f6-61b9-4ed5-b6b7-60c5037e21152026-03-05Warnings, Adverse reactionsName fallback
ErythromycinERYTHROMYCINREMEDYREPACK INC.c49ad63b-c2fd-4535-bec0-6415c93cf8472026-01-09Adverse reactionsName fallback
ErythromycinERYTHROMYCINRedpharm Drug301ee5ad-3b6c-1152-e063-6294a90a54e72025-12-23Adverse reactionsName fallback
ErythromycinERYTHROMYCINA-S Medication Solutions2be16639-b153-407b-b43d-3a2bcf66151e2025-12-03Adverse reactionsName fallback
EryERYTHROMYCINPadagis Israel Pharmaceuticals Ltd9a63da11-01be-4c63-a260-e6bdbb4a7a692025-10-31Warnings, Adverse reactionsName fallback
ErythromycinERYTHROMYCINPD-Rx Pharmaceuticals, Inc.e54d66fa-93bb-4339-a75e-194a2e4488aa2025-10-20Warnings, Adverse reactionsName fallback
ErythromycinERYTHROMYCINBryant Ranch Prepack10ad1391-32fc-40c0-96d0-675f3c91429f2025-10-20Warnings, Adverse reactionsName fallback
ERYTHROMYCINERYTHROMYCINAscend Laboratories, LLC3b415e31-e5d4-4990-8021-78459af733722025-10-17Warnings, Adverse reactionsName fallback
erythromycinERYTHROMYCINDr. Reddy's Labratories Inc.a2dcb48a-212c-1b0c-ec35-ee2ade85847f2025-09-25Warnings, Adverse reactionsName fallback
ErythromycinERYTHROMYCINA-S Medication Solutions99eb7dbc-6ba9-4122-ad1e-5cae731869322025-05-02Warnings, Adverse reactionsName fallback
Erythromycin EthylsuccinateERYTHROMYCINAmneal Pharmaceuticals NY LLC581d7430-1a80-42a6-befb-4c3ae81403922025-04-25Warnings, Adverse reactionsName fallback
ErythromycinERYTHROMYCINBausch & Lomb Incorporated061ddd20-94a6-4e3c-ba84-1ebd8529eea62025-04-22Adverse reactionsName fallback
ErythromycinERYTHROMYCINST. MARY'S MEDICAL PARK PHARMACY2cc726c2-3746-6dbf-e063-6294a90a789f2025-01-28Adverse reactionsName fallback

Adverse reactions cross-check#

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

adverse reactions

ADVERSE REACTIONS The most frequently reported adverse reactions are minor ocular irritations, redness, and hypersensitivity reactions. To report SUSPECTED ADVERSE REACTIONS, contact Bausch & Lomb Incorporated at 1-800-553-5340 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.