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FDA Approval

Chi-Myst

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

FDA Approval Summary

Company
Prescription Care LLC
DUNS: 080059076
Effective Date
August 19, 2016
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Bupivacaine(0.09 g in 30 mL)
Ketorolac(0.09 g in 30 mL)

Registrants1

Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.

Prescription Care LLC

080059076

Manufacturing Establishments1

FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.

Prescription Care LLC

Prescription Care LLC

Prescription Care LLC

080059076

Products1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Chi-Myst Topical

Product Details

NDC Product Code
70486-003
Route of Administration
TOPICAL
Effective Date
August 19, 2016
GLYCERINInactive
Code: PDC6A3C0OXClass: IACTQuantity: 0.3 mL in 30 mL
Code: 7TQO7W3VT8Class: ACTIRQuantity: 0.09 g in 30 mL
KetorolacActive
Code: 4EVE5946BQClass: ACTIMQuantity: 0.09 g in 30 mL
Code: SBD1A2I75NClass: ACTIBQuantity: 0.03 g in 30 mL
LACTIC ACID LACTATE, DL-Inactive
Code: N37QW3EK1LClass: IACTQuantity: 0.042 mL in 30 mL
WATERInactive
Code: 059QF0KO0RClass: IACTQuantity: 30 mL in 30 mL
SODIUM HYDROXIDEInactive
Code: 55X04QC32IClass: IACTQuantity: 0.0135 g in 30 mL
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