# 21 C.F.R. § 514.6 (2026): Amended applications

> Federal · Regulations · In force

URL: https://www.frixlaw.com/law-library/statutes/CFR_T21_P514_S514_6

## Section

- **Citation:** 21 C.F.R. § 514.6 (2026)
- **Heading:** Amended applications
- **Jurisdiction:** Federal
- **Kind:** Regulations
- **Status:** In force
- **Text as of:** August 14, 2026
- **Source:** Compiled text
- **Location:** Title 21 CFR: Food and Drugs / Chapter I: FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES / Part 514: NEW ANIMAL DRUG APPLICATIONS / Subpart A: General Provisions / § 514.6: § 514.6   Amended applications.

## Text

The applicant may submit an amendment to an application that is pending, including changes that may alter the conditions of use, the labeling, safety, effectiveness, identity, strength, quality, or purity of the drug or the adequacy of the manufacturing methods, facilities, and controls to preserve them, in which case the unamended application may be considered as withdrawn and the amended application may be considered resubmitted on the date on which the amendment is received by the Food and Drug Administration. The applicant will be notified of such date.

## Nearby sections

- [21 C.F.R. § 514.1 (2026) § 514.1   Applications.](https://www.frixlaw.com/law-library/statutes/CFR_T21_P514_S514_1.md)
- [21 C.F.R. § 514.3 (2026) § 514.3   Definitions.](https://www.frixlaw.com/law-library/statutes/CFR_T21_P514_S514_3.md)
- [21 C.F.R. § 514.4 (2026) § 514.4   Substantial evidence.](https://www.frixlaw.com/law-library/statutes/CFR_T21_P514_S514_4.md)
- [21 C.F.R. § 514.5 (2026) § 514.5   Presubmission conferences.](https://www.frixlaw.com/law-library/statutes/CFR_T21_P514_S514_5.md)
- [21 C.F.R. § 514.6 (2026) § 514.6   Amended applications.](https://www.frixlaw.com/law-library/statutes/CFR_T21_P514_S514_6.md)
- [21 C.F.R. § 514.7 (2026) § 514.7   Withdrawal of applications without prejudice.](https://www.frixlaw.com/law-library/statutes/CFR_T21_P514_S514_7.md)
- [21 C.F.R. § 514.8 (2026) § 514.8   Supplements and other changes to an approved application.](https://www.frixlaw.com/law-library/statutes/CFR_T21_P514_S514_8.md)
- [21 C.F.R. § 514.11 (2026) § 514.11   Confidentiality of data and information in a new animal drug application file.](https://www.frixlaw.com/law-library/statutes/CFR_T21_P514_S514_11.md)
- [21 C.F.R. § 514.12 (2026) § 514.12   Confidentiality of data and information in an investigational new animal drug notice.](https://www.frixlaw.com/law-library/statutes/CFR_T21_P514_S514_12.md)
- [21 C.F.R. § 514.15 (2026) § 514.15   Untrue statements in applications.](https://www.frixlaw.com/law-library/statutes/CFR_T21_P514_S514_15.md)

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Source: Frix Law Library, https://www.frixlaw.com/law-library/statutes/CFR_T21_P514_S514_6. Check the current official text before relying on it. Not legal advice.