GK-101E CARIES REMOVAL AGENT/SYSTEM
FDA premarket approval P830035 · decided 1984-07-06
Approval details
- PMA number
- P830035
- Trade name
- GK-101E CARIES REMOVAL AGENT/SYSTEM
- Generic name
- SOLUTION, REMOVAL, CARRIES
- Applicant
- Indevus Pharmaceuticals, Inc.
- Date received
- 1983-07-01
- Decision date
- 1984-07-06
- Days to decision
- 371 days
- Decision code
- APWD
- Product code
- LMW
- Advisory committee
- Dental
- Expedited review
- No
- Location
- Cranbury, NJ
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