Interested to Buy Any Domain ? << Click Here >> for more details...
which type of data need to file ANDA submission in USA ?
- 3 Answers
- 8576 Views
- I also Faced
- E-Mail Answers
Answers were Sorted based on User's Feedback
Answer / navinpatel
The 1984 Hatch-Waxman Act effectively extended the
Abbreviated New Drug Application (ANDA) processes that
existed for to all generic drugs. ANDA is filed for the
approval of Generic drug in US after the expiration of DATA
Exclusivity of innovator.
ANDAs do not contain clinical studies but are required to
contain information establishing bioequivalence to the
originator.
ANDA can be filed using the Para filing as below:
Para 1 – Drug has not been patented
Para 2 - Patent has already expired
Para 3 - Date on which the patent will expire and that the
generic drug will not go on the market until that date passes
Para 4 - Patent is not infringed or is invalid
Content of ANDA in ICH CTD format:
1. Application form
2. Table of contents
3. Basis for abbreviated new drug application submission
4. Conditions of use
5. Active ingredients
6. Route of administration, dosage form, and strength
7. Bioequivalence
8. Labeling
9. Chemistry, manufacturing, and controls
10.Samples
11.Patent information
ANDA submission with Para 4 certification will get 180 days
market exclusivity.
| Is This Answer Correct ? | 5 Yes | 0 No |
Answer / darose
information on drug substance- API (DMF)+ EXCIPIENTS
INFORMATION ON FINISHED PRODUCT, MANUFACTURING AND PACKAGING
(CMC)
INFORMATION ON DEVELOPMENT (R&D)
INFORMATION ON STABILITY OF FINISHED PODUCT
LABELING
| Is This Answer Correct ? | 3 Yes | 1 No |
What is the difference between Deviation and Out of Specification ?
what is immunity?
5 Answers GSK GlaxoSmithKline,
define process validation
Hi Sir?Mam, If i complete SAS CLINICAL in India, can i step forward to USA for job trials? How far is it possible? Am a B.pharm student ,willing to make up my Master's degree too,will this both M.Pharm and SAS help me out to get a job in USA? Please help me out with a good answer.
Tolerance limit for dissolution media rpm sampling point.
What is the role of buffers (ex: KH2PO4) in HPLC analysis,
how many persons involed for an internal audits?and who will audit the qa persons?
Anyone have any idea when to conduct Uniformity of Weight (UOW) and when need to conduct Uniformity of Dosage Units (UOD) or when need both? I read BP it only said if average weight < or = 0.04g then just conduct UOD, no need UOW. Under UOD section, it doesnt say when need to conduct UOD but just said UOD got two type, one is Mass Variation (MV), another is Content Uniformity (CU) and under what conditions to conduct them. For USP, no UOW section, only got UOD section.
0 Answers Alchem, Getz Pharma Research, Hovid Berhad,
concomitant administration of 6-mercaptopurine and which product results in severe bonemarrow suppression?
why use toline in resolution in uv calibration
what is the mechanism of action of local anaesthetics?
pls send me last two years solved papers of health & malaria inspector to kumar.santosh087@yahoo.com
Pharmacy 
