Answer / b.gangatharan

NDA means New Drug Application,sponsor of new drug must submit evidence of drug safety&effectiveness to meet FDA requirements for marketing approval,hence sponsor submits to FDA a New Drug Application(NDA)......ANDA means Abbreviated New Drug Application which is an application for US generic drug approval for an existing licensed medication or approved drug.
Thanks,
B.Gangatharan,
Caplin Point laboratory,
Puducherry.

Why pH range is maximum 14.0

6 Answers   UPL,

---

what is Fourier Transform

3 Answers   Graviti Pharmaceuticals, GVK,

---

What are the different types of columns used in HPLC

3 Answers   Wockhardt,

---

what is the difference between potentiometric titration and karl fischer titration?

0 Answers  

---

CAN WE DETERMINE THE PEAK PURITY IN GAS CHROMATOGRAPHY ANALYSIS?

0 Answers  

---

How require to develop GC method? how to select diluent, GAS, column selection and other chromatographic conditions?

0 Answers  

---

why did uyou choose analytical chemistry?

1 Answers  

---

In Dissolution Test why limit is define Q+5% what is the role of +5%.

0 Answers  

---

In which cases factor of KF Reaget got higher side

2 Answers  

---

What is difference b/w IR&NIR

1 Answers   Apotex,

---

what is MCG dilution in HPLC & GC analysis

1 Answers   Amoli Organics, Cipla,

---

[3/28, 20:52] Manoj P Venkatpurwar: how many impurities require to inject in assay specificity that how we can find out? and in Rs also how?

0 Answers  

---