Knowledge Base

How many types of NDA Classification Codes are there?

8 December 2023
2 min read

There are 11 NDA Classification Codes. 
Type 1 — New Molecular Entity.

Type 2 - New Active Ingredient.

Type 3 — New Dosage Form.

Type 4 — New Combination. 

Type 5 — New Formulation or Other Differences (e.g., new indication, new applicant, new manufacturer). 

Type 6 — New Indication or Claim, Same Applicant. 

Type 7 — Previously Marketed But Without an Approved NDA.

Type 8 — Rx to OTC.

Type 9 — New Indication or Claim, Drug Not to be Marketed Under Type 9 NDA After Approval.

Type 10 — New Indication or Claim, Drug to be Marketed Under Type 10 NDA After Approval.

Medical Gas — A Designated Medical Gas Certification Request Submitted Under Section 576 of the FD&C Act. 

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