The information below is a non-exhaustive list that references certain statutory and regulatory requirements and resources for an Abbreviated New Drug Application (ANDA) post approval. The requirements and resources listed apply to ANDAs that have received final approval. However, they do not cover all requirements that may apply to an approved ANDA. For the most updated guidances, see the FDA guidances search page.
- Changes to an Approved ANDA: Under section 506A of the Federal Food, Drug, and Cosmetic Act (FD&C Act), certain changes in the conditions described in approved ANDAs require an approved supplemental application before the change may be made. See also 21 CFR 314.70 and 314.97; Guidance for Industry, Changes to an Approved NDA or ANDA.
- Postmarketing reporting: Postmarketing reporting requirements applicable to ANDAs are set forth at 21 CFR 314.80-81 and 314.98. Among other things, FDA regulations require ANDA holders to notify the Agency of the marketing status of drug products approved under ANDAs, and section 506I of the FD&C Act imposes additional marketing status reporting requirements in certain circumstances. See Guidance for Industry, Marketing Status Notifications Under Section 506I of the Federal Food, Drug, and Cosmetic Act; Content and Format.
- Combination product safety reporting: ANDA products that are combination products as defined by 21 CFR 3.2(e) are subject to postmarketing safety reporting (PMSR) requirements for combination products. See 21 CFR Part 4, Subpart B; see also Guidance for Industry and FDA Staff, Postmarketing Safety Reporting for Combination Products.
- Promotional Materials: Applicants must submit specimens of mailing pieces and any other labeling or advertising devised for promotion of the drug product at the time of initial dissemination of the labeling and at the time of initial publication of the advertisement for a prescription drug product (21 CFR 314.81(b)(3)(i)).
- Each submission (also referred to as a 2253 submission) is required to be accompanied by a completed fillable Form FDA 2253 (Transmittal of Advertisements and Promotional Labeling for Drugs and Biologics for Human Use) and is required to include a copy of the product’s current professional labeling (21 CFR 314.81(b)(3)(i)). See also Guidance for Industry, Providing Regulatory Submissions in Electronic and Non-Electronic Format — Promotional Labeling and Advertising Materials for Human Prescription Drugs.
- For more information on the Office of Prescription Drug Promotion (OPDP) and related materials, see the OPDP website.
- Annual Facility Fees: The Generic Drug User Fee Amendments (GDUFA) requires owners of facilities producing generic drug products, active pharmaceutical ingredients (API), and certain other sites and organizations that support the manufacture or approval of these products to electronically self-identify with FDA and update that information annually. Most facilities that self-identify are required to pay an annual facility user fee. See section 744B(a)(4) and (f) of the FD&C Act; see also Guidance for Industry, Self-Identification of Generic Drug Facilities, Sites, and Organizations and FDA’s GDUFA website.
- Content of Labeling: FDA has issued regulations (the electronic labeling rule) requiring the submission of the content of labeling in electronic format for marketing applications (see 68 FR 69009).
- The requirements of the electronic labeling rule can be found in 21 CFR 314.94(d) for ANDAs and 21 CFR 314.81(b) for annual reports to marketing applications. See also Guidance for Industry, Providing Regulatory Submissions in Electronic Format — Content of Labeling. FDA currently accepts content of labeling in structured product labeling (SPL) format. For additional information, refer to the Structured Product Labeling Resources page.
Additional Helpful Documents
For the most updated Manuals of Policies and Procedures (MAPPs), see the search page for Center for Drug Evaluation and Research (CDER) MAPPs. MAPPs that may be helpful for ANDA applicants and holders include:
- MAPP 5220.2: Conversion of ANDA Approval to Tentative Approval Because of Court Order
- MAPP 5200.7: ANDA Amendments and Supplements Reviewed by the Division of Filing Review