Application Nr Approved Date Route Status External Links
ANDA040124 1996-01-24 Oral RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Carisoprodol Tablets, Usp Are Indicated For The Relief Of Discomfort Associated With Acute, Painful Musculoskeletal Conditions In Adults. Carisoprodol Tablets Should Only Be Used For Short Periods (up To Two Or Three Weeks) Because Adequate Evidence Of Effectiveness For More Prolonged Use Has Not Been Established And Because Acute, Painful Musculoskeletal Conditions Are Generally Of Short Duration. [see Dosage And Administration (2)]. Carisoprodol Tablets, Usp Are Indicated For The Relief Of Discomfort Associated With Acute, Painful Musculoskeletal Conditions. (1) Important Limitations: Should Only Be Used For Acute Treatment Periods Up To Two Or Three Weeks (1) Not Recommended In Pediatric Patients Less Than 16 Years Of Age (8.4)

All Formulated Excipients (6 Total)

Name Structure Kind Function Status
1. Lactose Monohydrate LACTOSE MONOHYDRATE Molecular
2. Magnesium Stearate MAGNESIUM STEARATE Molecular AF-Antifoaming (or defoaming) agent , MISC-Miscellaneous REG-Food additives for which a petition has been filed and a regulation issued.
3. Cellulose, Microcrystalline CELLULOSE, MICROCRYSTALLINE Unresolved
4. Methylcelluloses METHYLCELLULOSES Unresolved
5. Povidones POVIDONES Unresolved
6. Sodium Lauryl Sulfate SODIUM LAURYL SULFATE Molecular AF-Antifoaming (or defoaming) agent , CTG-Component or coating , EMUL-Emulsifier , SANI-Sanitizing agent , SDA-Solubilizing & dispersing agent REG-Food additives for which a petition has been filed and a regulation issued.

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Carisoprodol CARISOPRODOL ZINC1530950

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