SFDA item 24 · II. Quality changes · II.2 Finished product a) Description and composition
Change in concentration of a single-dose, total use parenteral product, where the amount of active substance per unit dose (i.e. the strength) remains the same
Variation category under SFDA, EU and US FDA rules for this change, with the variant wording as published.
SFDA Saudi Food and Drug Authority
Guidelines for Variation Requirements v6.3 (DS-G-006), item 24 — official PDF, p. 33 ↗
| Variant | Change | Type |
|---|---|---|
| - | Change in concentration of a single-dose, total use parenteral product, where the amount of active substance per unit dose (i.e. the strength) remains the same | Type II |
EU European Union
Commission Guidelines C/2025/5045 — EUR-Lex ↗
Q.II.a.5 · Change in concentration of a single-dose, total use parenteral product, where the amount of active substance per unit dose (i.e. the strength) remains the same
| Variant | Change | Type |
|---|---|---|
| - | Change in concentration of a single-dose, total use parenteral product, where the amount of active substance per unit dose (i.e. the strength) remains the same | Type II |
US FDA US Food and Drug Administration
21 CFR 314.70 and FDA guidance — 21 CFR 314.70(b)(2)(i) · 2004 Guidance §V, §IX.B.4
| Change | Category | Reference |
|---|---|---|
| Reformulation to a different concentration (quantitative formulation change) | Prior approval supplement | 2004 §V; 21 CFR 314.70(b)(2)(i) |
| Associated change in fill volume or container size of the sterile product | Prior approval supplement | 2004 §IX.B.4 |
Note: Both the formulation change and the sterile-container change are PAS, and the concentration and administration statements in the labeling change with them (314.70(b)(2)(v)(A)). ANDA parenterals must also keep inactive-ingredient sameness with the RLD (21 CFR 314.94(a)(9)(iii)).
Other items in II.2 Finished product a) Description and composition
- 20 · Change or addition of imprints, bossing or other markings including replacement, or addition of inks used for product marking.
- 21 · Change in the shape or dimensions of the pharmaceutical form*
- 22 · Changes in the composition (excipients) of the finished product
- 23 · Change in coating weight of oral dosage forms or change in weight of capsule shells
- 25 · Deletion of the solvent/diluent container from the pack
Not regulatory advice. The binding text is each regulator's current official document; confirm the category with the authority before filing. FDA publishes no classification table: the US category follows FDA guidance or, where the guidance does not name the change, the closest example under 21 CFR 314.70.