ENUCLENE(R) OPHTHALMIC SOLUTION
FDA premarket approval N13787/S003 · decided 1999-12-10
Approval details
- PMA number
- N13787
- Supplement
- S003
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Express GMP Supplement
- Trade name
- ENUCLENE(R) OPHTHALMIC SOLUTION
- Generic name
- Solution, cleaning / lubricating, artificial eye
- Applicant
- Alcon Research, Ltd.
- Date received
- 1999-10-25
- Decision date
- 1999-12-10
- Days to decision
- 46 days
- Decision code
- APPR
- Product code
- MSI
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Fort Worth, TX
- Statement
- Approval for the alternate manufacturing facility located at Alcon Laboratories, Inc., ASPEX Manufacturing Facility, 6201 South Freeway, Fort Worth, TX 76134.
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