ABBOTT IMX TACROLIMUS II
FDA premarket approval P970007/S001 · decided 1999-09-22
Approval details
- PMA number
- P970007
- Supplement
- S001
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- ABBOTT IMX TACROLIMUS II
- Generic name
- ENZYME IMMUNOASSAY, TRACROLIMUS
- Applicant
- Abbott Laboratories
- Date received
- 1999-09-17
- Decision date
- 1999-09-22
- Days to decision
- 5 days
- Decision code
- APPR
- Product code
- MLM
- Advisory committee
- Clinical Toxicology
- Expedited review
- No
- Location
- Abbott Park, IL
- Statement
- Approval for adding "Caution: This Product Contains Natural Dry Rubber" to the labeling.
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