Basic Information
Amoxicillin and Clavulanate Potassium
66685-1002
Regulatory Information
66685-1002
ANDA065117
C73584
September 16, 2022
USA
These highlights do not include all the information needed to use amoxicillin and clavulanate potassium safely and effectively. See full prescribing information for AMOXICILLIN AND CLAVULANATE POTASSIUM TABLETS, and AMOXICILLIN AND CLAVULANATE POTASSIUM FOR ORAL SUSPENSION. AMOXICILLIN and CLAVULANATE potassium tablets, and AMOXICILLIN and CLAVULANATE potassium for oral suspension, for oral useInitial U.S. Approval: 1984
HUMAN PRESCRIPTION DRUG LABEL
11
Company Information
005387188
Active Ingredients
SILICON DIOXIDE
Code: ETJ7Z6XBU4
Class Code: IACT
CROSCARMELLOSE SODIUM
Code: M28OL1HH48
Class Code: IACT
CROSPOVIDONE (15 MPA.S AT 5%)
Code: 68401960MK
Class Code: IACT
ETHYLCELLULOSE, UNSPECIFIED
Code: 7Z8S9VYZ4B
Class Code: IACT
MAGNESIUM STEARATE
Code: 70097M6I30
Class Code: IACT
HYDROXYPROPYL CELLULOSE (1600000 WAMW)
Code: RFW2ET671P
Class Code: IACT
MICROCRYSTALLINE CELLULOSE
Code: OP1R32D61U
Class Code: IACT
POLYSORBATE 80
Code: 6OZP39ZG8H
Class Code: IACT
TALC
Code: 7SEV7J4R1U
Class Code: IACT
TITANIUM DIOXIDE
Code: 15FIX9V2JP
Class Code: IACT
TRIETHYL CITRATE
Code: 8Z96QXD6UM
Class Code: IACT
Active Moieties
AMOXICILLIN ANHYDROUS
Code: 9EM05410Q9
CLAVULANIC ACID
Code: 23521W1S24