Description
Tablets and capsules are widely manufactured and prescribed and may provide a number of advantages over other dosage forms, including ease of storage, portability, ease of administration, and accuracy in dosing.
Scope & Applicability
Product Classes
4Reference Listed Drug used as the basis for an ANDA submission.
Agency recommends that generic oral tablets and capsules intended to be swallowed intact should be of a similar size to the corresponding RLD
The drug product identified by the applicant for comparison; Comparison of ANDA product to RLD for pH adjuster differences
Subject of the guidance document
Stakeholders
1Entity responsible for maintaining generic drug labeling
Regulatory Context
Attributes
4strategy to quantify changes in shape
refers to the length of oval or capsule shaped tablets or the diameter of round tablets
Physical attribute affecting esophageal transit
Physical attribute affecting patient compliance and swallowing
Identified Hazards
Hazards
2adverse events related to swallowing difficulties
Risk associated with larger tablets and capsules
Related CFR Sections (2)
- 21CFR320.22§ 320.22 Criteria for waiver of evidence of in vivo bioavailability or bioequivalence.
(a) Any person submitting a full or abbreviated new drug application, or a supplemental application proposing any of the changes set forth in § 320.21(c) , may request FDA to waive the requirement for the submission of evidence measuring the in vivo bioavailability or demonstrating the in vivo bioeqRead full regulation →
- 21CFR314.3§ 314.3 Definitions.
(a) The definitions and interpretations contained in section 201 of the Federal Food, Drug, and Cosmetic Act apply to those terms when used in this part and part 320 of this chapter .Read full regulation →
See Also (8)
- PET Drug Applications - Content and Format for NDAs and ANDAs_2011 (Status: Final)
- Bioavailability and Bioequivalence Studies Submitted in NDAs or INDs — General Considerations (Status: Draft)
- ANDA Submissions — Refuse to Receive for Lack of Justification of Impurity Limits: Guidance for Industry (Status: Final)
- Botanical Drug Development: Guidance for Industry (Status: Final)
- The Use of Physiologically Based Pharmacokinetic Analyses — Biopharmaceutics Applications for Oral Drug Product Development, Manufacturing Changes, and Controls : Draft Guidance for Industry (Status: Draft)
- Bioequivalence Studies With Pharmacokinetic Endpoints for Drugs Submitted Under an Abbreviated New Drug Application (Status: Draft)
- Bioavailability Studies Submitted in NDAs or INDs – General Considerations (Status: Final)
- Evaluation of Therapeutic Equivalence (Status: Draft)