The U.S. Food and Drug Administration has issued approval for ANDA 076507, submitted by TARO, covering oral Fluconazole tablets.
The application lists four tablet products (product numbers 001‑004) with strengths of 50 mg, 100 mg, 150 mg, and 200 mg. All are designated as discontinued marketing status.
Submission history includes an original filing on 29 July 2004 and multiple labeling supplements (submission numbers 1‑7) with the most recent on 19 Mar 2015. A manufacturing (CMC) supplement was filed on 9 Jan 2008.
No reference drug or reference standard is indicated for these products.
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