`
`APPLICA TION NUMBER:
`
`‘
`
`50-790 / 8-002 ’
`
`. CHEMISTRY REVIEWg S!
`
`
`
`SUPPLEMENT REVIEW
`
`DIVISION OF ANTI-INFLAMMATORY, ANALGESIC, & OPHTHALMIC DRUG PRODUCTS
`Review of Chemistry, Manufacturing, and Controls
`
`Chemistry Review # 1
`
`1. Division
`HFD-550
`
`2. NDA Number
`50-790
`
`3. Name and Address of Applicant
`Allergan
`2525 Dupont Drive
`PO Box 19534
`Irvine, CA
`
`5. Name of Drug
`Restasis
`
`7. Supplement Provides for:
`Provide additional '
`product.
`
`This is a CBE 30 supplement
`
`4. Supplement: SCS
`Number
`Letter Date
`S-002
`6/27/03
`
`Stamp Date
`6/30/03
`
`Due Date
`
`‘
`
`6. Nonproprietary Name.
`cyclosporine
`
`.
`
`of finished drug
`
`8. Amendment(s)
`SCS-002 BC, 7/29/03
`
`Signature
`
`9. Pharmacological Category
`Immunomodulator and anti-inflammatory.agent
`
`10. How Dispensed
`
`11. Related Documents
`
`12. Dosage Form
`Emulsion
`
`13. Potency(ies)
`0.05 %
`
`14. Chemical Name and Structure see USAN
`
`15. Comments:
`
`The supplement requests approval for the addition of tm
`
`W“ ,I
`
`Vin amendment dated 7/29/03
`
`Microbiologist recommended approval on the basis of product quality microbiology
`
`16. Conclusion:
`
`The supplementlS reCommended for approval from a chemistry, manufacturing, and control, standpoint
`
`Structure:
`
`
`
`WITHHOLD
`99%
`
`5L
`
`PAGE(S)
`
`
`
`This is a representation of an electronic record that was signed electronically and
`this page is the manifestation of the electronic signature.
`
`Su Tso
`
`9/10/03 04:22:18 PM
`CHEMIST
`
`Chemist’s review
`
`Linda Ng
`9/10/03 04:53:36 PM
`CHEMIST
`
`PM to prepare AP letter
`
`
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