fda approval no ?? need some info1!, page-2

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