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FDA ANDA 078553 Submission Documents – Diclofenac Sodium Ophthalmic Solution, 0.1%
FDA ANDA 078553 Submission Documents – Diclofenac Sodium Ophthalmic Solution, 0.1%
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Original Request: Diclofenac Sodium Ophthalmic Solution, 0.1% ANDA 078553 eCTD sequence from 0001 to 0006 and 0012. We are intending to manufacture this product at an alternate contract manufacturing organization (CMO). We would like to file a supplement submission with FDA with supporting data and planning to launch the product after approval. Therefore, we kindly request that the FDA promptly provide us with the above requested submitted copies.
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.
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