Data required to be submitted by an applicant forconduct of clinical trial of an approved new drug with new claims, namely, new indication or new dosage form or new route of administration or new strength

Number and date of permission or license already granted for the approved new drug.
Therapeutic justification for new claim- new indication or modified dosage form/new route of administration Chemical and Pharmaceutical information
Chemical name, code name or number, if any; non-proprietary or generic name, if any, structure; physico-chemical properties
- Dosage form and its composition
- Test specifications
  - active ingredients
  - inactive ingredients
- Tests for identification of the active ingredients and method of its assay
- Specifications of finished product
- Outline of the method of manufacture of active ingredient and finished product
- Stability data
Therapeutic justification for new claim or modified dosage form
Animal pharmacological and toxicological data as referred in clause 1, clause 2 and clause 3 of this Schedule
Clinical trial data as referred in clause 1 of this Schedule.
Regulatory status in other countries
Marketing information:
- Proposed package insert or promotional literature
- Draft specimen of the label and carton

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