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FDA Product

Carbamazepine

Product approved by U.S. Food and Drug Administration (US)

Basic Information

Carbamazepine

51672-4047

Regulatory Information

51672-4047

ANDA076729

C73584

March 29, 2024

USA

Carbamazepine Tablets USP, (Chewable), 100 mg and 200 mg Carbamazepine Tablets USP, 200 mg Carbamazepine Extended-Release Tablets USP, 100 mg, 200 mg, and 400 mg Carbamazepine Oral Suspension USP, 100 mg/5 mL

HUMAN PRESCRIPTION DRUG LABEL

8

Company Information

145186370

Active Ingredients

FD&C YELLOW NO. 6

Code: H77VEI93A8

Class Code: IACT

CITRIC ACID MONOHYDRATE

Code: 2968PHW8QP

Class Code: IACT

POLOXAMER 188

Code: LQA7B6G8JG

Class Code: IACT

PROPYLENE GLYCOL

Code: 6DC9Q167V3

Class Code: IACT

POTASSIUM SORBATE

Code: 1VPU26JZZ4

Class Code: IACT

XANTHAN GUM

Code: TTV12P4NEE

Class Code: IACT

CARBAMAZEPINE

Quantity: 100 mg in 5 mL

Code: 33CM23913M

Class Code: ACTIB

SORBITOL

Code: 506T60A25R

Class Code: IACT

SUCROSE

Code: C151H8M554

Class Code: IACT

WATER

Code: 059QF0KO0R

Class Code: IACT

Active Moieties

CARBAMAZEPINE

Code: 33CM23913M

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