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FDA Approval Routing Summary – ANDA 076485 for Isotretinoin Capsules 30 mg (Approved Aug 25, 2015)
FDA Approval Routing Summary – ANDA 076485 for Isotretinoin Capsules 30 mg (Approved Aug 25, 2015)
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Original Request Contents: Approval Routing Summary for ANDA 076485 for Isotretinoin Capsules, 30 mg, approved August 25, 2015
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity
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