GK-101E CARIES REMOVAL AGENT/SYSTEM
FDA premarket approval P830035/S001 · decided 1985-04-18
Approval details
- PMA number
- P830035
- Supplement
- S001
- Trade name
- GK-101E CARIES REMOVAL AGENT/SYSTEM
- Generic name
- SOLUTION, REMOVAL, CARRIES
- Applicant
- Indevus Pharmaceuticals, Inc.
- Date received
- 1984-10-01
- Decision date
- 1985-04-18
- Days to decision
- 199 days
- Decision code
- APPR
- Product code
- LMW
- Advisory committee
- Dental
- Expedited review
- No
- Location
- Cranbury, NJ
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