United States · Food and Drug Administration · Generics
Review target
304 days
performance goal
Legal time limit
-
Not published
Steps
3
4 requirements
Application fee
$375,684
FY2027
The route for a generic copy of an approved drug. The company shows that its product is bioequivalent to the reference listed drug instead of repeating clinical trials. The first applicants to challenge a patent can earn a 180-day exclusivity period. A copy of an approved drug that is bioequivalent to the reference listed drug.
The official review target is 304 days (performance goal, met in 90% of cases). Time the applicant takes to answer questions (clock stops) is not counted. Targets are not actual review times.
The anda application fee is $375,684 for FY2027.
1. Send the ANDA; 2. Assessment (304 days); 3. Decision.
Outcome: Approval, or a complete response letter.
Legal basis: Section 505(j) of the Federal Food, Drug, and Cosmetic Act; 21 CFR Part 314 Subpart C
Each box is one step; arrows show the order. Dashed boxes happen only in some cases; the orange arrows go back (for example after questions).
About 304 days end to end with the official step targets. Targets, not actual times.
From the official approvals data of this market, all products of this pathway type and segment
In order, with the official target for each step
What the applicant must provide or meet
Targets, not actual review times
| First review cycleperformance goal. About 8 months for priority ANDAs when a complete pre-submission facility correspondence is sent on time. This is an official target, not an actual review time. | 243 days |
| Review targetperformance goal, met in 90% of cases. About 10 months from submission for 90 percent of standard original ANDAs. This is an official target, not an actual review time. | 304 days |
Official amounts in the local currency
| Fee | Amount |
|---|---|
| Generic drug applicant program fee, largeYearly · FY2027 | $1,927,291 |
| ANDA application feeApplication · FY2027 · Facility fees and a yearly program fee also apply. | $375,684 |
Other routes in United States: New drug application (full, new active ingredient), New drug application relying on other data (505(b)(2)), Over-the-counter monograph order, Prescription to nonprescription switch, Breakthrough therapy designation, Fast track designation, Accelerated approval, Priority review, Orphan drug designation, National priority voucher (pilot), Emergency use authorization, Expanded access (compassionate use), Pediatric study requirements. See all routes on the United States page or explore them in the .
Not legal or regulatory advice. Check the current official rules before you act. This summary was checked against the official laws, regulations and regulator guidance on October 3, 2026 (9 facts checked). Parts of the approvals data are official open data reused under open licences. Data sources.
| Finished dosage form facility, outside the USEstablishment · FY2027 | $245,033 |
| Finished dosage form facility, USEstablishment · FY2027 | $230,033 |
| Generic drug applicant program fee, small businessYearly · FY2027 | $192,729 |
| Drug master fileOther · FY2027 | $109,899 |