ANDA #091316
Unless your contact is working for the FDA and or Dr Reddy's and specifically on this approval I doubt they could provide anything further than what we know and we know that:
- All sections have been reviewed
- Chemistry, Manufacturing and Controls (CMC)
- Labeling
- Microbiology
- Bioequivalence
- Other (Packaging, Device)
* Awaiting approval from FDA
- Pre-approval inspection of fill-finisher complete
- Part of routine inspection
- CMO currently FDA approved
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- fda approval no ?? need some info1!
fda approval no ?? need some info1!, page-2
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