azithromycin 500 MG Oral Tablet

RxCUI
248656
RxNorm name
azithromycin 500 MG Oral Tablet
Display name
azithromycin 500 MG Oral Tablet
Full name
azithromycin 500 MG Oral Tablet
Term type
SCD
Status
DailyMed mapping
Updated
2026-06-04 23:39:17

RxNav Current And Historical NDCs#

RxNav current and historical NDC rows page 1 of 1 · 0 matching rows.

No records found.

UNII Substances#

UNII substance links page 1 of 1 · 0 matching rows.

No records found.

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 4 · 62 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AzithromycinAZITHROMYCINREMEDYREPACK INC.614cc2a4-3fc7-455d-9e8a-212c496f0fbf2026-08-05Warnings, Adverse reactionsExact identifier
rxcui: 248656
Azithromycin DihydrateAZITHROMYCIN DIHYDRATEREMEDYREPACK INC.c7ed6985-1d1d-48af-9df8-64b12821789e2026-08-04Warnings, Adverse reactionsExact identifier
rxcui: 248656
Azithromycin DihydrateAZITHROMYCIN DIHYDRATENuCare Pharmaceuticals,Inc.21c67de0-3a4e-caab-e063-6394a90ae3cd2026-07-30Warnings, Adverse reactionsExact identifier
rxcui: 248656
AzithromycinAZITHROMYCINA-S Medication Solutions882f71b1-b153-4856-b4a7-1a29ae9cf2472026-07-29Warnings, Adverse reactionsExact identifier
rxcui: 248656
Azithromycin DihydrateAZITHROMYCIN DIHYDRATEPD-Rx Pharmaceuticals, Inc.0c926669-62b2-4ad3-8289-173c5818a9c12026-07-29Warnings, Adverse reactionsExact identifier
rxcui: 248656
azithromycinAZITHROMYCINMajor Pharmaceuticals814abe38-da4a-48af-bf4b-2ce04a5aabd12026-07-27Warnings, Adverse reactionsExact identifier
rxcui: 248656
ZithromaxAZITHROMYCIN DIHYDRATEPfizer Laboratories Div Pfizer Incdb52b91e-79f7-4cc1-9564-f2eee8e31c452026-07-24Warnings, Adverse reactionsExact identifier
rxcui: 248656
AzithromycinAZITHROMYCINA-S Medication Solutions58308e8b-57bd-4e82-a2e8-24aac63194cd2026-07-23Warnings, Adverse reactionsExact identifier
rxcui: 248656
AzithromycinAZITHROMYCINBryant Ranch Prepack2a8010dc-700f-45d3-94ca-ebe4a51acc1b2026-07-20Warnings, Adverse reactionsExact identifier
rxcui: 248656
AzithromycinAZITHROMYCINREMEDYREPACK INC.943b9246-7733-44b1-875c-91d2ade78ac42026-06-29Warnings, Adverse reactionsExact identifier
rxcui: 248656
Azithromycin DihydrateAZITHROMYCIN DIHYDRATEBryant Ranch Prepack7d78cd8e-0c63-46d6-b018-939fcbbe42a62026-06-24Warnings, Adverse reactionsExact identifier
rxcui: 248656
AzithromycinAZITHROMYCINPreferred Pharmaceuticals Inc.661ff7a6-6394-493d-a307-a1f607e5d1172026-06-16Warnings, Adverse reactionsExact identifier
rxcui: 248656
Azithromycin DihydrateAZITHROMYCIN DIHYDRATEREMEDYREPACK INC.7711e846-0bb3-486c-8511-f445e264cd982026-06-12Warnings, Adverse reactionsExact identifier
rxcui: 248656
AzithromycinAZITHROMYCINBryant Ranch Prepackb5d79719-b1dc-469f-a19c-f8ba615138f02026-05-14Warnings, Adverse reactionsExact identifier
rxcui: 248656
AzithromycinAZITHROMYCINSportpharm LLC397471e5-76e2-462c-af30-bcc54fe002662026-04-24Warnings, Adverse reactionsExact identifier
rxcui: 248656
AzithromycinAZITHROMYCINAurobindo Pharma Limited795c13cd-e9ca-481b-9fa9-2890bdf9dac82026-04-16Warnings, Adverse reactionsExact identifier
rxcui: 248656
Azithromycin DihydrateAZITHROMYCIN DIHYDRATEPrecision Dose, Inc.3962bc34-8236-4ac1-8ffd-2edbd430c3eb2026-04-08Warnings, Adverse reactionsExact identifier
rxcui: 248656
AzithromycinAZITHROMYCINBryant Ranch Prepacka81212ef-76b6-4bd7-8706-3d2b05ee34f92026-03-30Warnings, Adverse reactionsExact identifier
rxcui: 248656
AzithromycinAZITHROMYCINA-S Medication Solutions24c07398-84ad-48e2-9625-e9073c28fb732026-03-24Warnings, Adverse reactionsExact identifier
rxcui: 248656
AzithromycinAZITHROMYCINA-S Medication Solutions77c5e4c6-6d16-40fe-bf36-cb441348f39b2026-03-24Warnings, Adverse reactionsExact identifier
rxcui: 248656

DailyMed RxNorm Mappings#

unique DailyMed labels mapped to this RxNorm concept page 1 of 3 · 93 matching rows.

Set ID, RxNorm mappings, Terms table
Set IDRxNorm mappingsTermsSPL versionLabelEffective
b5d79719-b1dc-469f-a19c-f8ba615138f0azithromycin 500 MG Oral Tablet [PSN] · azithromycin 500 MG Oral Tablet [SCD] · azithromycin 500 MG (as azithromycin monohydrate) Oral Tablet [SY]3103These highlights do not include all the information needed to use AZITHROMYCIN TABLETS safely and effectively. See full prescribing information for AZITHROMYCIN TABLETS. AZITHROMYCIN tablets, for oral use Initial U.S. Approval: 199120260514
db52b91e-79f7-4cc1-9564-f2eee8e31c45azithromycin 500 MG Oral Tablet [PSN] · azithromycin 500 MG Oral Tablet [SCD] · azithromycin 500 MG (as azithromycin monohydrate) Oral Tablet [SY]348These highlights do not include all the information needed to use ZITHROMAX ® safely and effectively. See full prescribing information for ZITHROMAX. ZITHROMAX (azithromycin) 250 mg and 500 mg tablets, for oral use ZITHROMAX (azithromycin) for oral suspension Initial U.S. Approval: 199120260107
f6a52c0b-45db-422e-8c22-e867a11b4439azithromycin 500 MG Oral Tablet [PSN] · azithromycin 500 MG Oral Tablet [SCD] · azithromycin 500 MG (as azithromycin monohydrate) Oral Tablet [SY]322These highlights do not include all the information needed to use AZITHROMYCIN TABLETS safely and effectively. See full prescribing information for AZITHROMYCIN TABLETS. AZITHROMYCIN tablets, for oral use Initial U.S. Approval: 199120230301
943b9246-7733-44b1-875c-91d2ade78ac4azithromycin 500 MG Oral Tablet [PSN] · azithromycin 500 MG Oral Tablet [SCD] · azithromycin 500 MG (as azithromycin monohydrate) Oral Tablet [SY]317These highlights do not include all the information needed to use AZITHROMYCIN TABLETS safely and effectively. See full prescribing information for AZITHROMYCIN TABLETS. AZITHROMYCIN tablets, for oral use Initial U.S. Approval: 199120260109
614cc2a4-3fc7-455d-9e8a-212c496f0fbfazithromycin 500 MG Oral Tablet [PSN] · azithromycin 500 MG Oral Tablet [SCD] · azithromycin 500 MG (as azithromycin monohydrate) Oral Tablet [SY]314These highlights do not include all the information needed to use AZITHROMYCIN TABLETS safely and effectively. See full prescribing information for AZITHROMYCIN TABLETS. AZITHROMYCIN tablets, for oral use Initial U.S. Approval: 199120260512
9977e757-7643-45ef-b5df-ee894438b466azithromycin 500 MG Oral Tablet [PSN] · azithromycin 500 MG Oral Tablet [SCD] · azithromycin 500 MG (as azithromycin monohydrate) Oral Tablet [SY]314These highlights do not include all the information needed to use AZITHROMYCIN TABLETS safely and effectively. See full prescribing information for AZITHROMYCIN TABLETS. AZITHROMYCIN tablets, for oral use Initial U.S. Approval: 199120180618
45410338-6bff-476b-b8e1-6c6238205a99azithromycin 500 MG Oral Tablet [PSN] · azithromycin 500 MG Oral Tablet [SCD] · azithromycin 500 MG (as azithromycin monohydrate) Oral Tablet [SY]312These highlights do not include all the information needed to use AZITHROMYCIN TABLETS safely and effectively. See full prescribing information for AZITHROMYCIN TABLETS. AZITHROMYCIN tablets, for oral use Initial U.S. Approval: 199120220225
77c5e4c6-6d16-40fe-bf36-cb441348f39bazithromycin 500 MG Oral Tablet [PSN] · azithromycin 500 MG Oral Tablet [SCD] · azithromycin 500 MG (as azithromycin monohydrate) Oral Tablet [SY]311These highlights do not include all the information needed to use AZITHROMYCIN TABLETS safely and effectively. See full prescribing information for AZITHROMYCIN TABLETS. AZITHROMYCIN tablets, for oral use Initial U.S. Approval: 199120260324
c7ed6985-1d1d-48af-9df8-64b12821789eazithromycin 500 MG Oral Tablet [PSN] · azithromycin 500 MG Oral Tablet [SCD] · azithromycin 500 MG (as azithromycin monohydrate) Oral Tablet [SY]310These highlights do not include all the information needed to use AZITHROMYCIN TABLETS safely and effectively. See full prescribing information for AZITHROMYCIN TABLETS. AZITHROMYCIN tablets, for oral use Initial U.S. Approval: 199120260406
a2b0c06b-e93d-f5aa-e053-2995a90ac9aaazithromycin 500 MG Oral Tablet [PSN] · azithromycin 500 MG Oral Tablet [SCD] · azithromycin 500 MG (as azithromycin monohydrate) Oral Tablet [SY]39These highlights do not include all the information needed to use AZITHROMYCIN TABLETS safely and effectively. See full prescribing information for AZITHROMYCIN TABLETS. AZITHROMYCIN tablets, 250 mg and 500 mg Initial U.S. Approval: 199120250513
795c13cd-e9ca-481b-9fa9-2890bdf9dac8azithromycin 500 MG Oral Tablet [PSN] · azithromycin 500 MG Oral Tablet [SCD] · azithromycin 500 MG (as azithromycin monohydrate) Oral Tablet [SY]38These highlights do not include all the information needed to use AZITHROMYCIN TABLETS safely and effectively. See full prescribing information for AZITHROMYCIN TABLETS. AZITHROMYCIN tablets, for oral use Initial U.S. Approval: 199120260416
24c07398-84ad-48e2-9625-e9073c28fb73azithromycin 500 MG Oral Tablet [PSN] · azithromycin 500 MG Oral Tablet [SCD] · azithromycin 500 MG (as azithromycin monohydrate) Oral Tablet [SY]38These highlights do not include all the information needed to use AZITHROMYCIN TABLETS safely and effectively. See full prescribing information for AZITHROMYCIN TABLETS. AZITHROMYCIN tablets, for oral use Initial U.S. Approval: 199120260324
b635019e-7fd4-7f9e-e053-2a95a90a388cazithromycin 500 MG Oral Tablet [PSN] · azithromycin 500 MG Oral Tablet [SCD] · azithromycin 500 MG (as azithromycin monohydrate) Oral Tablet [SY]38Azithromycin Tablets, USP Rx Only These highlights do not include all the information needed to use AZITHROMYCIN TABLETS safely and effectively. See full prescribing information for AZITHROMYCIN TABLETS. Initial U.S. Approval: 199120260108
01649d79-4677-4577-a3e4-e054f3f9fc3bazithromycin 500 MG Oral Tablet [PSN] · azithromycin 500 MG Oral Tablet [SCD] · azithromycin 500 MG (as azithromycin monohydrate) Oral Tablet [SY]38These highlights do not include all the information needed to use AZITHROMYCIN TABLETS safely and effectively. See full prescribing information for AZITHROMYCIN TABLETS. AZITHROMYCIN tablets, 250 mg and 500 mg, for oral use Initial U.S. Approval: 199120251023
7e7c2f49-449c-4ba2-98ae-0ff0c040614cazithromycin 500 MG Oral Tablet [PSN] · azithromycin 500 MG Oral Tablet [SCD] · azithromycin 500 MG (as azithromycin monohydrate) Oral Tablet [SY]38AZITHROMYCIN Tablets USP 250 mg and 500 mg20221001
a5b4092d-ab72-f5d1-e053-2995a90ac582azithromycin 500 MG Oral Tablet [PSN] · azithromycin 500 MG Oral Tablet [SCD] · azithromycin 500 MG (as azithromycin monohydrate) Oral Tablet [SY]37AZITHROMYCIN20260317
003307c5-3f73-4a5d-a704-bfdea3c656e8azithromycin 500 MG Oral Tablet [PSN] · azithromycin 500 MG Oral Tablet [SCD] · azithromycin 500 MG (as azithromycin monohydrate) Oral Tablet [SY]37These highlights do not include all the information needed to use AZITHROMYCIN TABLETS safely and effectively. See full prescribing information for AZITHROMYCIN TABLETS. AZITHROMYCIN tablets, for oral use Initial U.S. Approval: 199120260316
859bb02c-a4bc-46fa-9fc9-def1219b5dfbazithromycin 500 MG Oral Tablet [PSN] · azithromycin 500 MG Oral Tablet [SCD] · azithromycin 500 MG (as azithromycin monohydrate) Oral Tablet [SY]37These highlights do not include all the information needed to use AZITHROMYCIN TABLETS safely and effectively. See full prescribing information for AZITHROMYCIN TABLETS. AZITHROMYCIN tablets, for oral use Initial U.S. Approval: 199120251204
2c8c977f-6acf-40f9-8a5b-253eb0188ed2azithromycin 500 MG Oral Tablet [PSN] · azithromycin 500 MG Oral Tablet [SCD] · azithromycin 500 MG (as azithromycin monohydrate) Oral Tablet [SY]37These highlights do not include all the information needed to use AZITHROMYCIN TABLETS safely and effectively. See full prescribing information for AZITHROMYCIN TABLETS. AZITHROMYCIN tablets, for oral use Initial U.S. Approval: 199120180828
a81212ef-76b6-4bd7-8706-3d2b05ee34f9azithromycin 500 MG Oral Tablet [PSN] · azithromycin 500 MG Oral Tablet [SCD] · azithromycin 500 MG (as azithromycin monohydrate) Oral Tablet [SY]36These highlights do not include all the information needed to use AZITHROMYCIN TABLETS safely and effectively. See full prescribing information for AZITHROMYCIN TABLETS. AZITHROMYCIN tablets, for oral use Initial U.S. Approval: 199120260330
0c926669-62b2-4ad3-8289-173c5818a9c1azithromycin 500 MG Oral Tablet [PSN] · azithromycin 500 MG Oral Tablet [SCD] · azithromycin 500 MG (as azithromycin monohydrate) Oral Tablet [SY]36These highlights do not include all the information needed to use AZITHROMYCIN TABLETS safely and effectively. See full prescribing information for AZITHROMYCIN TABLETS. AZITHROMYCIN tablets, for oral use Initial U.S. Approval: 199120260105
fb2f83a2-507b-4cf3-81ea-d10c46c0f8eaazithromycin 500 MG Oral Tablet [PSN] · azithromycin 500 MG Oral Tablet [SCD] · azithromycin 500 MG (as azithromycin monohydrate) Oral Tablet [SY]36These highlights do not include all the information needed to use AZITHROMYCIN TABLETS safely and effectively. See full prescribing information for AZITHROMYCIN TABLETS. AZITHROMYCIN tablets, for oral use Initial U.S. Approval: 199120231204
334fc377-ab51-418e-ad4b-2a243718095eazithromycin 500 MG Oral Tablet [PSN] · azithromycin 500 MG Oral Tablet [SCD] · azithromycin 500 MG (as azithromycin monohydrate) Oral Tablet [SY]36These highlights do not include all the information needed to use AZITHROMYCIN TABLETS safely and effectively. See full prescribing information for AZITHROMYCIN TABLETS. AZITHROMYCIN tablets, for oral use Initial U.S. Approval: 199120230607
0494df57-f514-4274-8e38-dd79023fedb0azithromycin 500 MG Oral Tablet [PSN] · azithromycin 500 MG Oral Tablet [SCD] · azithromycin 500 MG (as azithromycin monohydrate) Oral Tablet [SY]36These highlights do not include all the information needed to use AZITHROMYCIN TABLETS safely and effectively. See full prescribing information for AZITHROMYCIN TABLETS. AZITHROMYCIN tablets, for oral use Initial U.S. Approval: 199120211028
de58d218-7127-46f2-8578-e7a5c02140d1azithromycin 500 MG Oral Tablet [PSN] · azithromycin 500 MG Oral Tablet [SCD] · azithromycin 500 MG (as azithromycin monohydrate) Oral Tablet [SY]36These highlights do not include all the information needed to use AZITHROMYCIN TABLETS safely and effectively. See full prescribing information for AZITHROMYCIN TABLETS. AZITHROMYCIN tablets, 250 mg and 500 mg, for oral use Initial U.S. Approval: 199120180614
2fd1f4b5-6c32-3075-e063-6294a90a0d4bazithromycin 500 MG Oral Tablet [PSN] · azithromycin 500 MG Oral Tablet [SCD] · azithromycin 500 MG (as azithromycin monohydrate) Oral Tablet [SY]35These highlights do not include all the information needed to use AZITHROMYCIN TABLETS safely and effectively. See full prescribing information for AZITHROMYCIN TABLETS. AZITHROMYCIN tablets, for oral use Initial U.S. Approval: 199120251227
94e17ae5-0871-67a0-e053-2995a90ae0aeazithromycin 500 MG Oral Tablet [PSN] · azithromycin 500 MG Oral Tablet [SCD] · azithromycin 500 MG (as azithromycin monohydrate) Oral Tablet [SY]35These highlights do not include all the information needed to use AZITHROMYCIN TABLETS safely and effectively. See full prescribing information for AZITHROMYCIN TABLETS. AZITHROMYCIN tablets, for oral use Initial U.S. Approval: 199120251219
814abe38-da4a-48af-bf4b-2ce04a5aabd1azithromycin 500 MG Oral Tablet [PSN] · azithromycin 500 MG Oral Tablet [SCD] · azithromycin 500 MG (as azithromycin monohydrate) Oral Tablet [SY]35These highlights do not include all the information needed to use AZITHROMYCIN TABLETS safely and effectively. See full prescribing information for AZITHROMYCIN TABLETS. AZITHROMYCIN tablets, 250 mg and 500 mg, for oral use Initial U.S. Approval: 199120250703
0f36ba37-a742-41c1-ad2d-b890a1d49c55azithromycin 500 MG Oral Tablet [PSN] · azithromycin 500 MG Oral Tablet [SCD] · azithromycin 500 MG (as azithromycin monohydrate) Oral Tablet [SY]35These highlights do not include all the information needed to use AZITHROMYCIN TABLETS safely and effectively. See full prescribing information for AZITHROMYCIN TABLETS. AZITHROMYCIN tablets, for oral use Initial U.S. Approval: 199120230206
962bd404-62b5-4a7f-8ad4-45284228ac0fazithromycin 500 MG Oral Tablet [PSN] · azithromycin 500 MG Oral Tablet [SCD] · azithromycin 500 MG (as azithromycin monohydrate) Oral Tablet [SY]35These highlights do not include all the information needed to use AZITHROMYCIN TABLETS safely and effectively. See full prescribing information for AZITHROMYCIN TABLETS. AZITHROMYCIN Tablets, for oral use Initial U.S. Approval: 199120220209
fe52f9fe-da0f-47e5-899e-a5513fb7688dazithromycin 500 MG Oral Tablet [PSN] · azithromycin 500 MG Oral Tablet [SCD] · azithromycin 500 MG (as azithromycin monohydrate) Oral Tablet [SY]35These highlights do not include all the information needed to use AZITHROMYCIN TABLETS safely and effectively. See full prescribing information for AZITHROMYCIN TABLETS. AZITHROMYCIN tablets, for oral use Initial U.S. Approval: 199120211027
cd108535-4bc5-4d5b-a3c1-6fb9f533194dazithromycin 500 MG Oral Tablet [PSN] · azithromycin 500 MG Oral Tablet [SCD] · azithromycin 500 MG (as azithromycin monohydrate) Oral Tablet [SY]35These highlights do not include all the information needed to use AZITHROMYCIN TABLETS safely and effectively. See full prescribing information for AZITHROMYCIN TABLETS. AZITHROMYCIN tablets, for oral use Initial U.S. Approval: 199120201215
3962bc34-8236-4ac1-8ffd-2edbd430c3ebazithromycin 500 MG Oral Tablet [PSN] · azithromycin 500 MG Oral Tablet [SCD] · azithromycin 500 MG (as azithromycin monohydrate) Oral Tablet [SY]34These highlights do not include all the information needed to use AZITHROMYCIN TABLETS safely and effectively. See full prescribing information for AZITHROMYCIN TABLETS. AZITHROMYCIN tablets, for oral use Initial U.S. Approval: 199120260408
a6426d5f-5518-3c69-e053-2995a90af50fazithromycin 500 MG Oral Tablet [PSN] · azithromycin 500 MG Oral Tablet [SCD] · azithromycin 500 MG (as azithromycin monohydrate) Oral Tablet [SY]34AZITHROMYCIN20260317
dc633b7d-5154-7e43-e053-2a95a90ad2a6azithromycin 500 MG Oral Tablet [PSN] · azithromycin 500 MG Oral Tablet [SCD] · azithromycin 500 MG (as azithromycin monohydrate) Oral Tablet [SY]34Azithromycin Tablets, USP Rx Only These highlights do not include all the information needed to use AZITHROMYCIN TABLETS safely and effectively. See full prescribing information for AZITHROMYCIN TABLETS. Initial U.S. Approval: 199120260317
de5b0c2b-9a7d-46e9-8169-4100442efa9bazithromycin 500 MG Oral Tablet [PSN] · azithromycin 500 MG Oral Tablet [SCD] · azithromycin 500 MG (as azithromycin monohydrate) Oral Tablet [SY]34These highlights do not include all the information needed to use AZITHROMYCIN TABLETS safely and effectively. See full prescribing information for AZITHROMYCIN TABLETS. AZITHROMYCIN tablets, for oral use Initial U.S. Approval: 199120260303
6169e56c-10fb-448d-ab0f-14e54fcf2817azithromycin 500 MG Oral Tablet [PSN] · azithromycin 500 MG Oral Tablet [SCD] · azithromycin 500 MG (as azithromycin monohydrate) Oral Tablet [SY]34These highlights do not include all the information needed to use AZITHROMYCIN TABLETS safely and effectively. See full prescribing information for AZITHROMYCIN TABLETS. AZITHROMYCIN tablets, 250 mg and 500 mg, for oral use Initial U.S. Approval: 199120250612
ec619299-e0ef-44dd-acdb-8c53bbfc5b8aazithromycin 500 MG Oral Tablet [PSN] · azithromycin 500 MG Oral Tablet [SCD] · azithromycin 500 MG (as azithromycin monohydrate) Oral Tablet [SY]34These highlights do not include all the information needed to use AZITHROMYCIN TABLETS safely and effectively. See full prescribing information for AZITHROMYCIN TABLETS. AZITHROMYCIN tablets for oral use Initial U.S. Approval: 199120220121
77f12139-2e38-4298-b4f4-c24976cf0636azithromycin 500 MG Oral Tablet [PSN] · azithromycin 500 MG Oral Tablet [SCD] · azithromycin 500 MG (as azithromycin monohydrate) Oral Tablet [SY]34These highlights do not include all the information needed to use AZITHROMYCIN TABLETS safely and effectively. See full prescribing information for AZITHROMYCIN TABLETS. AZITHROMYCIN tablets, for oral use Initial U.S. Approval: 199120170221
00dab70c-53ab-4a08-a6f0-1d78cbe43926azithromycin 500 MG Oral Tablet [PSN] · azithromycin 500 MG Oral Tablet [SCD] · azithromycin 500 MG (as azithromycin monohydrate) Oral Tablet [SY]33These highlights do not include all the information needed to use AZITHROMYCIN TABLETS safely and effectively. See full prescribing information for AZITHROMYCIN TABLETS. AZITHROMYCIN tablets, for oral use Initial U.S. Approval: 199120230607